II 

117TH CONGRESS 

2D SESSION S. 4348 

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 

the user-fee programs for prescription drugs, medical devices, generic 

drugs, and biosimilar biological products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 26, 2022 

Mrs. MURRAY (for herself and Mr. BURR) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

revise and extend the user-fee programs for prescription 

drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Food and Drug Administration Safety and Landmark 

6 Advancements Act of 2022’’ or the ‘‘FDASLA Act of 

7 2022’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents for 

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use drug fees. 

Sec. 104. Reauthorization; reporting requirement. 

Sec. 105. Sunset dates. 

Sec. 106. Effective date. 

Sec. 107. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 201. Short title; finding. 

Sec. 202. Definitions. 

Sec. 203. Authority to assess and use device fees. 

Sec. 204. Accreditation programs. 

Sec. 205. Sunset dates. 

Sec. 206. Effective date. 

Sec. 207. Savings clause. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title; finding. 

Sec. 302. Authority to assess and use human generic drug fees. 

Sec. 303. Reauthorization; reporting requirements. 

Sec. 304. Sunset dates. 

Sec. 305. Effective date. 

Sec. 306. Savings clause. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 

PRODUCTS 

Sec. 401. Short title; finding. 

Sec. 402. Definitions. 

Sec. 403. Authority to assess and use biosimilar biological product fees. 

Sec. 404. Reauthorization; reporting requirements. 

Sec. 405. Sunset dates. 

Sec. 406. Effective date. 

Sec. 407. Savings clause. 

TITLE V—IMPROVING REGULATION OF DRUGS AND BIOLOGICAL 

PRODUCTS 

Sec. 501. Alternatives to animal testing. 

Sec. 502. Safer disposal of opioids. 

Sec. 503. Clarifications to exclusivity provisions for first interchangeable biosimilar biological products. 

Sec. 504. Improvements to the Purple Book. 

Sec. 505. Therapeutic equivalence evaluations. 

Sec. 506. Modernizing accelerated approval. 


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TITLE VI—OTHER REAUTHORIZATIONS 

Sec. 601. Reauthorization of the critical path public-private partnership. 

Sec. 602. Reauthorization of the best pharmaceuticals for children program. 

Sec. 603. Reauthorization of the humanitarian device exemption incentive. 

Sec. 604. Reauthorization of the pediatric device consortia program. 

Sec. 605. Reauthorization of provision pertaining to drugs containing single 

enantiomers. 

Sec. 606. Reauthorization of orphan drug grants. 

Sec. 607. Reauthorization of certain device inspections. 

TITLE VII—ENHANCING FDA HIRING AUTHORITIES 

Sec. 701. Enhancing FDA hiring authority for scientific, technical, and professional personnel. 

Sec. 702. Strategic workforce plan and report. 

TITLE VIII—ADVANCING REGULATION OF COSMETICS, DIETARY 

SUPPLEMENTS, AND LABORATORY DEVELOPED TESTS 

Subtitle A—Cosmetics 

Sec. 801. Short title. 

Sec. 802. Amendments to cosmetic requirements. 

Sec. 803. Enforcement and conforming amendments. 

Sec. 804. Records inspection. 

Sec. 805. Talc-containing cosmetics. 

Sec. 806. PFAS in cosmetics. 

Sec. 807. Funding. 

Subtitle B—Dietary Supplements 

Sec. 811. Regulation of dietary supplements. 

Subtitle C—In Vitro Clinical Tests 

Sec. 821. Short title; table of contents. 

Sec. 822. Definitions. 

Sec. 823. Regulation of in vitro clinical tests. 

Sec. 824. Enforcement and other provisions. 

Sec. 825. Transition. 

Sec. 826. Emergency use authorization. 

Sec. 827. Antimicrobial susceptibility tests. 

Sec. 828. Combination products. 

Sec. 829. Resources. 

Sec. 830. Authorization of appropriations. 

TITLE IX—OTHER PROVISIONS 

Sec. 901. Facilities management. 

Sec. 902. Annual report on inspections. 

Sec. 903. User fee program transparency and accountability. 

Sec. 904. OTC hearing aids final rule. 

Sec. 905. Enhance intra-agency coordination and public health assessment with 

regard to compliance activities. 


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1 TITLE I—FEES RELATING TO 

2 DRUGS 

3 SEC. 101. SHORT TITLE; FINDING. 

4 (a) SHORT TITLE.—This title may be cited as the 

5 ‘‘Prescription Drug User Fee Amendments of 2022’’. 

6 (b) FINDING.—Congress finds that the fees author7 ized by the amendments made in this title will be dedi8 cated toward expediting the drug development process and 

9 the process for the review of human drug applications, in10 cluding postmarket drug safety activities, as set forth in 

11 the goals identified for purposes of part 2 of subchapter 

12 C of chapter VII of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 379g et seq.), in the letters from the Sec14 retary of Health and Human Services to the Chairman 

15 of the Committee on Health, Education, Labor, and Pen16 sions of the Senate and the Chairman of the Committee 

17 on Energy and Commerce of the House of Representa18 tives, as set forth in the Congressional Record. 

19 SEC. 102. DEFINITIONS. 

20 Section 735 of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 379g) is amended— 

22 (1) in paragraph (1), in the matter following 

23 subparagraph (B), by striking ‘‘an allergenic extract 

24 product, or’’ and inserting ‘‘does not include an ap25 plication with respect to an allergenic extract prodVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 uct licensed before October 1, 2022, does not include 

2 an application with respect to a standardized aller3 genic extract product submitted pursuant to a notifi4 cation to the applicant from the Secretary regarding 

5 the existence of a potency test that measures the al6 lergenic activity of an allergenic extract product li7 censed by the applicant before October 1, 2022, does 

8 not include an application with respect to’’; 

9 (2) in paragraph (3), in the matter following 

10 subparagraph (C)— 

11 (A) by inserting ‘‘licensed before October 

12 1, 2022, a standardized allergenic extract prod13 uct submitted pursuant to a notification to the 

14 applicant from the Secretary regarding the ex15 istence of a potency test that measures the al16 lergenic activity of an allergenic extract product 

17 licensed by the applicant before October 1, 

18 2022,’’ after ‘‘an allergenic extract product’’; 

19 (B) by adding at the end the following: ‘‘If 

20 a written request to place a product in the dis21 continued section of either of the lists described 

22 in subparagraph (C) is submitted to the Sec23 retary on behalf of an applicant, and the re24 quest identifies the date the product is, or will 

25 be, withdrawn from sale, then, for purposes of 


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1 assessing the prescription drug program fee 

2 under section 736(a)(2), the Secretary shall 

3 consider such product to have been included in 

4 the discontinued section on the later of (i) the 

5 date such request was received, or (ii) if the 

6 product will be withdrawn from sale on a future 

7 date, such future date when the product is 

8 withdrawn from sale. For purposes of subpara9 graph (C), a product shall be considered with10 drawn from sale once the applicant has ceased 

11 its own distribution of the product, whether or 

12 not the applicant has ordered recall of all pre13 viously distributed lots of the product, except 

14 that a routine, temporary interruption in supply 

15 shall not render a product withdrawn from 

16 sale.’’; and 

17 (C) by adding at the end the following: 

18 ‘‘(12) The term ‘skin-test diagnostic product’— 

19 ‘‘(A) means a product— 

20 ‘‘(i) for prick, scratch, intradermal, or 

21 subcutaneous administration; 

22 ‘‘(ii) expected to produce a limited, 

23 local reaction at the site of administration 

24 (if positive), rather than a systemic effect; 


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1 ‘‘(iii) not intended to be a preventive 

2 or therapeutic intervention; and 

3 ‘‘(iv) intended to detect an immediate 

4 or delayed-type skin hypersensitivity reac5 tion to aid in the diagnosis of— 

6 ‘‘(I) an allergy to an anti7 microbial agent; 

8 ‘‘(II) an allergy that is not to an 

9 antimicrobial agent, if the diagnostic 

10 product was authorized for marketing 

11 prior to October 1, 2022; or 

12 ‘‘(III) infection with fungal or 

13 mycobacterial pathogens; and 

14 ‘‘(B) includes positive and negative con15 trols required to interpret the results of a prod16 uct described in subparagraph (A).’’. 

17 SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 

18 (a) TYPES OF FEES.—Section 736(a) of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is 

20 amended— 

21 (1) in the matter preceding paragraph (1), by 

22 striking ‘‘2018’’ and inserting ‘‘2023’’; 

23 (2) in paragraph (1)— 


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1 (A) in subparagraph (A), by striking ‘‘sub2 section (c)(5)’’ each place it appears and insert3 ing ‘‘subsection (c)(6)’’; 

4 (B) in subparagraph (C), by inserting 

5 ‘‘prior to approval’’ after ‘‘or was withdrawn’’; 

6 and 

7 (C) by adding at the end the following: 

8 ‘‘(H) EXCEPTION FOR SKIN-TEST DIAG9 NOSTIC PRODUCTS.—A human drug application 

10 for a skin-test diagnostic product shall not be 

11 subject to a fee under subparagraph (A).’’; and 

12 (3) in paragraph (2)— 

13 (A) in subparagraph (A)— 

14 (i) by striking ‘‘subsection (c)(5)’’ and 

15 inserting ‘‘subsection (c)(6)’’; 

16 (ii) by striking ‘‘Except as provided’’ 

17 and inserting the following: 

18 ‘‘(i) PAYMENT OF FEES.—Except as 

19 provided’’; and 

20 (iii) by adding at the end the fol21 lowing: 

22 ‘‘(ii) PREVIOUSLY DISCONTINUED

23 DRUG PRODUCTS.—If a drug product that 

24 is identified in a human drug application 

25 approved as of October 1 of a fiscal year 


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1 is not a prescription drug product as of 

2 that date because the drug product is in 

3 the discontinued section of a list identified 

4 in section 735(3), and on any subsequent 

5 day during such fiscal year the drug prod6 uct is a prescription drug product, then ex7 cept as provided in subparagraphs (B) and 

8 (C), each person who is named as the ap9 plicant in a human drug application with 

10 respect to such product, and who, after 

11 September 1, 1992, had pending before the 

12 Secretary a human drug application or 

13 supplement, shall pay the annual prescrip14 tion drug program fee established for a fis15 cal year under subsection (c)(6) for such 

16 prescription drug product. Such fee shall 

17 be due on the last business day of such fis18 cal year and shall be paid only once for 

19 each product for a fiscal year in which the 

20 fee is payable.’’; and 

21 (B) by amending subparagraph (B) to read 

22 as follows: 

23 ‘‘(B) EXCEPTION FOR CERTAIN PRESCRIP24 TION DRUG PRODUCTS.—A prescription drug 

25 program fee shall not be assessed for a preVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 scription drug product under subparagraph (A) 

2 if such product is— 

3 ‘‘(i) a large volume parenteral product 

4 (a sterile aqueous drug product packaged 

5 in a single-dose container with a volume 

6 greater than or equal to 100 mL, not in7 cluding powders for reconstitution or phar8 macy bulk packages) identified on the list 

9 compiled under section 505(j)(7); 

10 ‘‘(ii) pharmaceutically equivalent (as 

11 defined in section 314.3 of title 21, Code 

12 of Federal Regulations (or any successor 

13 regulations)), to another product on the 

14 list of products compiled under section 

15 505(j)(7) (not including the discontinued 

16 section of such list); or 

17 ‘‘(iii) a skin-test diagnostic product.’’. 

18 (b) FEE REVENUE AMOUNTS.—Section 736(b) of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 379h(b)) is amended— 

21 (1) in paragraph (1)— 

22 (A) in the matter preceding subparagraph 

23 (A), by striking ‘‘2018 through 2022’’ and in24 serting ‘‘2023 through 2027’’; 


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1 (B) by redesignating subparagraphs (C) 

2 through (F) as subparagraphs (D) through (G), 

3 respectively; 

4 (C) by inserting after subparagraph (B) 

5 the following: 

6 ‘‘(C) The dollar amount equal to the stra7 tegic hiring and retention adjustment for the 

8 fiscal year (as determined under subsection 

9 (c)(2));’’; 

10 (D) in subparagraph (D), as so redesig11 nated, by striking ‘‘(c)(2)’’ and inserting 

12 ‘‘(c)(3)’’; 

13 (E) in subparagraph (E), as so redesig14 nated, by striking ‘‘(c)(3)’’ and inserting 

15 ‘‘(c)(4)’’; 

16 (F) in subparagraph (F), as so redesig17 nated, by striking ‘‘(c)(4)’’ and inserting 

18 ‘‘(c)(5)’’; and 

19 (G) in subparagraph (G), as so redesig20 nated, by striking clauses (i) through (v) and 

21 inserting the following: 

22 ‘‘(i) $65,773,693 for fiscal year 2023. 

23 ‘‘(ii) $25,097,671 for fiscal year 2024. 

24 ‘‘(iii) $14,154,169 for fiscal year 

25 2025. 


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1 ‘‘(iv) $4,864,860 for fiscal year 2026. 

2 ‘‘(v) $1,314,620 for fiscal year 

3 2027.’’; and 

4 (2) in paragraph (3)— 

5 (A) in subparagraph (A), by striking 

6 ‘‘2018, $878,590,000’’ and inserting ‘‘2023, 

7 $1,151,522,958’’; and 

8 (B) in subparagraph (B)— 

9 (i) by striking ‘‘2019 through 2022’’ 

10 and inserting ‘‘2024 through 2027’’; and 

11 (ii) by striking ‘‘subsection (c)(3) or 

12 (c)(4)’’ and inserting ‘‘subsection (c)(4) or 

13 (c)(5)’’. 

14 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 

15 736(c) of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 379h(c)) is amended— 

17 (1) in paragraph (1)(B)(ii), by striking ‘‘Wash18 ington-Baltimore, DC–MD–VA–WV’’ and inserting 

19 ‘‘Washington–Arlington–Alexandria, DC–VA–MD– 

20 WV’’; 

21 (2) by redesignating paragraphs (2) through 

22 (6) as paragraphs (3) through (7), respectively; 

23 (3) by inserting after paragraph (1) the fol24 lowing: 


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1 ‘‘(2) STRATEGIC HIRING AND RETENTION AD2 JUSTMENT.—For each fiscal year, after the annual 

3 base revenue established in subsection (b)(1)(A) is 

4 adjusted for inflation in accordance with paragraph 

5 (1), the Secretary shall further increase the fee rev6 enue and fees— 

7 ‘‘(A) for fiscal year 2023, by $9,000,000; 

8 and 

9 ‘‘(B) for fiscal year 2024 and each subse10 quent fiscal year, by $4,000,000.’’; 

11 (4) in paragraph (3), as so redesignated— 

12 (A) in subparagraph (A)— 

13 (i) by striking ‘‘for inflation’’; and 

14 (ii) by striking ‘‘paragraph (1)’’ and 

15 inserting ‘‘paragraphs (1) and (2)’’; 

16 (B) by amending subparagraph (B) to read 

17 as follows: 

18 ‘‘(B) METHODOLOGY.—For purposes of 

19 this paragraph, the Secretary shall employ the 

20 capacity planning methodology utilized by the 

21 Secretary in setting fees for fiscal year 2021, as 

22 described in the notice titled ‘Prescription Drug 

23 User Fee Rates for Fiscal Year 2021’ (85 Fed. 

24 Reg. 46651; August 3, 2020). The workload 

25 categories used in forecasting shall include only 


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1 the activities described in such notice and, as 

2 feasible, additional activities that are directly 

3 related to the direct review of applications and 

4 supplements, including additional formal meet5 ing types, the direct review of postmarketing 

6 commitments and requirements, the direct re7 view of risk evaluation and mitigation strate8 gies, and the direct review of annual reports for 

9 approved prescription drug products. Subject to 

10 the exceptions in the preceding sentence, the 

11 Secretary shall not include as workload cat12 egories in forecasting any non-core review ac13 tivities, including any activities that the Sec14 retary referenced for potential future use in 

15 such notice but did not utilize in the setting 

16 fees for fiscal year 2021.’’; 

17 (C) by striking subparagraph (C); 

18 (D) by redesignating subparagraphs (D) 

19 and (E) as subparagraphs (C) and (D), respec20 tively; 

21 (E) in subparagraph (C), as so redesig22 nated— 

23 (i) by striking ‘‘year) and’’ and insert24 ing ‘‘year),’’; and 


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1 (ii) by inserting ‘‘, and subsection 

2 (b)(1)(C) (the dollar amount of the stra3 tegic hiring and retention adjustment).’’; 

4 and 

5 (F) in subparagraph (D), as so redesig6 nated, by striking ‘‘paragraph (5)’’ and insert7 ing ‘‘paragraph (6)’’; 

8 (5) in paragraph (4), as so redesignated— 

9 (A) by amending subparagraph (A) to read 

10 as follows: 

11 ‘‘(A) INCREASE.—For fiscal year 2023 and 

12 subsequent fiscal years, the Secretary shall, in 

13 addition to adjustments under paragraphs (1), 

14 (2), and (3), further increase the fee revenue 

15 and fees if such an adjustment is necessary to 

16 provide for at least the following amounts of op17 erating reserves of carryover user fees for the 

18 process for the review of human drug applica19 tions for each fiscal year, as follows: 

20 ‘‘(i) For fiscal year 2023, at least 8 

21 weeks of operating reserves. 

22 ‘‘(ii) For fiscal year 2024, at least 9 

23 weeks of operating reserves. 


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1 ‘‘(iii) For fiscal year 2025 and subse2 quent fiscal years, at least 10 weeks of op3 erating reserves.’’; and 

4 (B) in subparagraph (C), by striking 

5 ‘‘paragraph (5)’’ and inserting ‘‘paragraph 

6 (6)’’; 

7 (6) by amending paragraph (5), as so redesig8 nated, to read as follows: 

9 ‘‘(5) ADDITIONAL DIRECT COST ADJUST10 MENT.—The Secretary shall, in addition to adjust11 ments under paragraphs (1), (2), (3), and (4), fur12 ther increase the fee revenue and fees— 

13 ‘‘(A) for fiscal year 2023, by $44,386,150; 

14 and 

15 ‘‘(B) for fiscal years 2024 through 2027, 

16 by the amount set forth in clauses (i) through 

17 (iv), as applicable, multiplied by the Consumer 

18 Price Index for urban consumers (Washington– 

19 Arlington–Alexandria, DC–VA–MD–WV; Not 

20 Seasonally Adjusted; All Items; Annual Index) 

21 for the most recent year of available data, di22 vided by such Index for 2021— 

23 ‘‘(i) for fiscal year 2024, $60,967,993; 

24 ‘‘(ii) for fiscal year 2025, 

25 $35,799,314; 


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1 ‘‘(iii) for fiscal year 2026, 

2 $35,799,314; and 

3 ‘‘(iv) for fiscal year 2027, 

4 $35,799,314.’’; and 

5 (7) in paragraph (6), as so redesignated, by 

6 striking ‘‘2017’’ and inserting ‘‘2022’’. 

7 (d) CREDITING AND AVAILABILITY OF FEES.—Sec8 tion 736(g)(3) of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 379h(g)(3)) is amended by striking ‘‘2018 

10 through 2022’’ and inserting ‘‘2023 through 2027’’. 

11 (e) WRITTEN REQUESTS FOR WAIVERS, REDUC12 TIONS, AND REFUNDS.—Section 736(i) of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is 

14 amended to read as follows: 

15 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC16 TIONS, EXEMPTIONS, AND RETURNS; DISPUTES CON17 CERNING FEES.—To qualify for consideration for a waiver 

18 or reduction under subsection (d), an exemption under 

19 subsection (k), or the return of any fee paid under this 

20 section, including if the fee is claimed to have been paid 

21 in error, a person shall submit to the Secretary a written 

22 request justifying such waiver, reduction, exemption, or 

23 return not later than 180 days after such fee is due. A 

24 request submitted under this paragraph shall include any 

25 legal authorities under which the request is made.’’. 


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1 (f) ORPHAN DRUGS.—Section 736(k) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is 

3 amended— 

4 (1) in paragraph (1)(B), by striking ‘‘during 

5 the previous year’’ and inserting ‘‘, as determined 

6 under paragraph (2)’’; and 

7 (2) in paragraph (2), by striking ‘‘that its gross 

8 annual revenues’’ and all that follows through the 

9 period at the end and inserting ‘‘supported by tax 

10 returns submitted to the Internal Revenue Service, 

11 or, as necessary, by other appropriate financial in12 formation, that its gross annual revenues did not ex13 ceed $50,000,000 for the last calendar year ending 

14 prior to the fiscal year for which the exemption is 

15 requested.’’. 

16 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENT. 

17 Section 736B of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 379h–2) is amended— 

19 (1) by striking ‘‘2018’’ each place it appears 

20 and inserting ‘‘2023’’; 

21 (2) by striking ‘‘Prescription Drug User Fee 

22 Amendments of 2017’’ each place it appears and in23 serting ‘‘Prescription Drug User Fee Amendments 

24 of 2022’’; 


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1 (3) in subsection (a)(4), by striking ‘‘2020’’ and 

2 inserting ‘‘2023’’; and 

3 (4) in subsection (f), by striking ‘‘2022’’ each 

4 place it appears and inserting ‘‘2027’’. 

5 SEC. 105. SUNSET DATES. 

6 (a) AUTHORIZATION.—Sections 735 and 736 of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 

8 379h) shall cease to be effective October 1, 2027. 

9 (b) REPORTING REQUIREMENTS.—Section 736B of 

10 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 379h–2) shall cease to be effective January 31, 2028. 

12 (c) PREVIOUS SUNSET PROVISION.—Effective Octo13 ber 1, 2022, subsections (a) and (b) of section 104 of the 

14 FDA Reauthorization Act of 2017 (Public Law 115–52) 

15 are repealed. 

16 SEC. 106. EFFECTIVE DATE. 

17 The amendments made by this title shall take effect 

18 on October 1, 2022, or the date of the enactment of this 

19 Act, whichever is later, except that fees under part 2 of 

20 subchapter C of chapter VII of the Federal Food, Drug, 

21 and Cosmetic Act (21 U.S.C. 379g et seq.) shall be as22 sessed for all human drug applications received on or after 

23 October 1, 2022, regardless of the date of the enactment 

24 of this Act. 


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1 SEC. 107. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

3 part 2 of subchapter C of chapter VII of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in 

5 effect on the day before the date of the enactment of this 

6 title, shall continue to be in effect with respect to human 

7 drug applications and supplements (as defined in such 

8 part as of such day) that were accepted by the Food and 

9 Drug Administration for filing on or after October 1, 

10 2017, but before October 1, 2022, with respect to assess11 ing and collecting any fee required by such part for a fiscal 

12 year prior to fiscal year 2023. 

13 TITLE II—FEES RELATING TO 

14 DEVICES 

15 SEC. 201. SHORT TITLE; FINDING. 

16 (a) SHORT TITLE.—This title may be cited as the 

17 ‘‘Medical Device User Fee Amendments of 2022’’. 

18 (b) FINDING.—Congress finds that the fees author19 ized under the amendments made by this title will be dedi20 cated toward expediting the process for the review of de21 vice applications and for assuring the safety and effective22 ness of devices, as set forth in the goals identified for pur23 poses of part 3 of subchapter C of chapter VII of the Fed24 eral Food, Drug, and Cosmetic Act in the letters from the 

25 Secretary of Health and Human Services to the Chairman 

26 of the Committee on Health, Education, Labor, and PenVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 sions of the Senate and the Chairman of the Committee 

2 on Energy and Commerce of the House of Representa3 tives, as set forth in the Congressional Record. 

4 SEC. 202. DEFINITIONS. 

5 Section 737 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 379i) is amended— 

7 (1) in paragraph (9)— 

8 (A) in the matter preceding subparagraph 

9 (A), by striking ‘‘and premarket notification 

10 submissions’’ and inserting ‘‘premarket notifica11 tion submissions, and de novo classification re12 quests’’; 

13 (B) in subparagraph (D), by striking ‘‘and 

14 submissions’’ and inserting ‘‘submissions, and 

15 de novo classification requests’’; 

16 (C) in subparagraph (F), by striking ‘‘and 

17 premarket notification submissions’’ and insert18 ing ‘‘premarket notification submissions, and de 

19 novo classification requests’’; 

20 (D) in subparagraphs (G) and (H), by 

21 striking ‘‘or submissions’’ each place it appears 

22 and inserting ‘‘submissions, or requests’’; and 

23 (E) in subparagraph (K), by striking ‘‘or 

24 premarket notification submissions’’ and insertVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 ing ‘‘premarket notification submissions, or de 

2 novo classification requests’’; and 

3 (2) in paragraph (11), by striking ‘‘2016’’ and 

4 inserting ‘‘2021’’. 

5 SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

6 (a) TYPES OF FEES.—Section 738(a) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is 

8 amended— 

9 (1) in paragraph (1), by striking ‘‘2018’’ and 

10 inserting ‘‘2023’’; and 

11 (2) in paragraph (2)— 

12 (A) in subparagraph (A)— 

13 (i) in the matter preceding clause (i), 

14 by striking ‘‘2017’’ and inserting ‘‘2022’’; 

15 (ii) in clause (iii), by striking ‘‘75 per16 cent’’ and inserting ‘‘80 percent’’; and 

17 (iii) in clause (viii), by striking ‘‘3.4 

18 percent’’ and inserting ‘‘4.5 percent’’; 

19 (B) in subparagraph (B)(iii), by striking 

20 ‘‘or premarket notification submission’’ and in21 serting ‘‘premarket notification submission, or 

22 de novo classification request’’; and 

23 (C) in subparagraph (C), by striking ‘‘or 

24 periodic reporting concerning a class III device’’ 

25 and inserting ‘‘periodic reporting concerning a 


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1 class III device, or de novo classification re2 quest’’. 

3 (b) FEE AMOUNTS.—Section 738(b) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is 

5 amended— 

6 (1) in paragraph (1), by striking ‘‘2018 

7 through 2022’’ and inserting ‘‘2023 through 2027’’; 

8 (2) by amending the table in paragraph (2) to 

9 read as follows: 

‘‘Fee Type 

Fiscal 

Year 

2023 

Fiscal 

Year 

2024 

Fiscal 

Year 

2025 

Fiscal 

Year 

2026 

Fiscal 

Year 

2027 

Premarket Application ........ $425,000 $435,000 $445,000 $455,000 $470,000

Establishment 

Registration .. $6,250 $6,875 $7,100 $7,575 $8,465’’; 

10 and 

11 (3) in paragraph (3), by amending subpara12 graphs (A) through (E) to read as follows: 

13 ‘‘(A) $312,606,000 for fiscal year 2023. 

14 ‘‘(B) $335,750,000 for fiscal year 2024. 

15 ‘‘(C) $350,746,400 for fiscal year 2025. 

16 ‘‘(D) $366,486,300 for fiscal year 2026. 

17 ‘‘(E) $418,343,000 for fiscal year 2027.’’. 

18 (c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 

19 738(c) of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 379j(c)) is amended— 


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1 (1) in paragraph (1), by striking ‘‘2017’’ and 

2 inserting ‘‘2022’’; 

3 (2) in paragraph (2)— 

4 (A) by striking ‘‘2018’’ each place it ap5 pears and inserting ‘‘2023’’; 

6 (B) in subparagraph (B)(ii), by striking 

7 ‘‘2016’’ and inserting ‘‘2022’’; 

8 (C) in subparagraph (C)(i)(II), by striking 

9 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ 

10 and inserting ‘‘Washington–Arlington–Alexan11 dria, DC–VA–MD–WV’’; and 

12 (D) in subparagraph (D), by striking 

13 ‘‘2022’’ and inserting ‘‘2027’’; 

14 (3) in paragraph (3), by striking ‘‘2018 

15 through 2022’’ and inserting ‘‘2023 through 2027’’; 

16 (4) by redesignating paragraphs (4) and (5) as 

17 paragraphs (7) and (8), respectively; and 

18 (5) by inserting after paragraph (3) the fol19 lowing: 

20 ‘‘(4) PERFORMANCE IMPROVEMENT ADJUST21 MENT.— 

22 ‘‘(A) IN GENERAL.—For each of fiscal 

23 years 2025 through 2027, after the adjustment 

24 under paragraph (3), the base establishment 

25 registration fee amounts for such fiscal year 


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1 shall be increased to reflect changes in the re2 source needs of the Secretary due to improved 

3 review performance goals for the process for the 

4 review of device applications identified in the 

5 letters described in section 201(b) of the Med6 ical Device User Fee Amendments of 2022, as 

7 the Secretary determines necessary to achieve 

8 an increase in total fee collections for such fis9 cal year, equal to the following amounts, as ap10 plicable: 

11 ‘‘(i) For fiscal year 2025, the product 

12 of— 

13 ‘‘(I) the amount determined 

14 under subparagraph (B)(i)(I); and 

15 ‘‘(II) the applicable inflation ad16 justment under paragraph (2)(B) for 

17 such fiscal year. 

18 ‘‘(ii) For fiscal year 2026, the product 

19 of— 

20 ‘‘(I) the sum of the amounts de21 termined under subparagraphs 

22 (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); 

23 and 


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1 ‘‘(II) the applicable inflation ad2 justment under paragraph (2)(B) for 

3 such fiscal year. 

4 ‘‘(iii) For fiscal year 2027, the prod5 uct of— 

6 ‘‘(I) the sum of the amounts de7 termined under subparagraphs 

8 (B)(i)(III), (B)(ii)(II), and 

9 (B)(iii)(II); and 

10 ‘‘(II) the applicable inflation ad11 justment under paragraph (2)(B) for 

12 such fiscal year. 

13 ‘‘(B) AMOUNTS.— 

14 ‘‘(i) PRESUBMISSION AMOUNT.—For 

15 purposes of subparagraph (A), with respect 

16 to the presubmission written feedback goal, 

17 the amounts determined under this sub18 paragraph are as follows: 

19 ‘‘(I) For fiscal year 2025, 

20 $15,396,600 if the goal for fiscal year 

21 2023 is met. 

22 ‘‘(II) For fiscal year 2026— 

23 ‘‘(aa) $15,396,600 if the 

24 goal for fiscal year 2023 is met 


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1 and the goal for fiscal year 2024 

2 is missed; or 

3 ‘‘(bb) $36,792,200 if the 

4 goal for fiscal year 2024 is met. 

5 ‘‘(III) For fiscal year 2027— 

6 ‘‘(aa) $15,396,600 if the 

7 goal for fiscal year 2023 is met 

8 and the goal for each of fiscal 

9 years 2024 and 2025 is missed; 

10 ‘‘(bb) $36,792,200 if the 

11 goal for fiscal year 2024 is met 

12 and the goal for fiscal year 2025 

13 is missed; or 

14 ‘‘(cc) $40,572,600 if the 

15 goal for fiscal year 2025 is met. 

16 ‘‘(ii) DE NOVO CLASSIFICATION RE17 QUEST AMOUNT.—For purposes of sub18 paragraph (A), with respect to the de novo 

19 decision goal, the amounts determined 

20 under this subparagraph are as follows: 

21 ‘‘(I) For fiscal year 2026, 

22 $6,323,500 if the goal for fiscal year 

23 2023 is met. 

24 ‘‘(II) For fiscal year 2027— 


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1 ‘‘(aa) $6,323,500 if the goal 

2 for fiscal year 2023 is met and 

3 the goal for fiscal year 2024 is 

4 missed; or 

5 ‘‘(bb) $11,765,400 if the 

6 goal for fiscal year 2024 is met. 

7 ‘‘(iii) PREMARKET NOTIFICATION AND

8 PREMARKET APPROVAL AMOUNT.—For 

9 purposes of subparagraph (A), with respect 

10 to the 510(k) decision goal, 510(k) shared 

11 outcome total time to decision goal, PMA 

12 decision goal, and PMA shared outcome 

13 total time to decision goal, the amounts de14 termined under this subparagraph are as 

15 follows: 

16 ‘‘(I) For fiscal year 2026, 

17 $1,020,000 if the 4 goals for fiscal 

18 year 2023 are met. 

19 ‘‘(II) For fiscal year 2027— 

20 ‘‘(aa) $1,020,000 if the 4 

21 goals for fiscal year 2023 are met 

22 and one or more of the 4 goals 

23 for fiscal year 2024 is missed; or 


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1 ‘‘(bb) $3,906,000 if the 4 

2 goals for fiscal year 2024 are 

3 met. 

4 ‘‘(C) PERFORMANCE CALCULATION.—For 

5 purposes of this paragraph, performance of the 

6 following goals shall be determined as specified 

7 in the letters described in section 201(b) of the 

8 Medical Device User Fee Amendments of 2022 

9 and based on data available as of the applicable 

10 dates as follows: 

11 ‘‘(i) The performance of the pre12 submission written feedback goal— 

13 ‘‘(I) for fiscal year 2023, shall be 

14 based on data available as of March 

15 31, 2024; 

16 ‘‘(II) for fiscal year 2024, shall 

17 be based on data available as of 

18 March 31, 2025; and 

19 ‘‘(III) for fiscal year 2025, shall 

20 be based on data available as of 

21 March 31, 2026. 

22 ‘‘(ii) The performance of the de novo 

23 decision goal, 510(k) decision goal, 510(k) 

24 shared outcome total time to decision goal, 


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1 PMA decision goal, and PMA shared out2 come total time to decision goal— 

3 ‘‘(I) for fiscal year 2023, shall be 

4 based on data available as of March 

5 31, 2025; and 

6 ‘‘(II) for fiscal year 2024, shall 

7 be based on data available as of 

8 March 31, 2026. 

9 ‘‘(D) DEFINITIONS.—For purposes of this 

10 paragraph, the terms ‘presubmission written 

11 feedback goal’, ‘de novo decision goal’, ‘510(k) 

12 decision goal’, ‘510(k) shared outcome total 

13 time to decision goal’, ‘PMA decision goal’, and 

14 ‘PMA shared outcome total time to decision 

15 goal’ have the meanings given such terms in the 

16 goals identified in the letters described in sec17 tion 201(b) of the Medical Device User Fee 

18 Amendments of 2022. 

19 ‘‘(5) HIRING ADJUSTMENT.— 

20 ‘‘(A) IN GENERAL.—For each of fiscal 

21 years 2025 through 2027, after the adjust22 ments under paragraphs (3) and (4), if applica23 ble, the base establishment registration fee 

24 amounts shall be decreased as the Secretary de25 termines necessary to achieve a reduction in 


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1 total fee collections equal to the hiring adjust2 ment amount under subparagraph (B), if the 

3 number of hires to support the process for the 

4 review of device applications falls below the fol5 lowing thresholds for the applicable fiscal years: 

6 ‘‘(i) For fiscal year 2025, 85 percent 

7 of the hiring goal specified in subpara8 graph (C) for fiscal year 2023. 

9 ‘‘(ii) For fiscal year 2026, 90 percent 

10 of the hiring goal specified in subpara11 graph (C) for fiscal year 2024. 

12 ‘‘(iii) For fiscal year 2027, 90 percent 

13 of the hiring goal specified in subpara14 graph (C) for fiscal year 2025. 

15 ‘‘(B) HIRING ADJUSTMENT AMOUNT.—The 

16 hiring adjustment amount for fiscal year 2025 

17 and each subsequent fiscal year is the product 

18 of— 

19 ‘‘(i) the number of hires by which the 

20 hiring goal specified in subparagraph (C) 

21 for the fiscal year before the prior fiscal 

22 year was missed; 

23 ‘‘(ii) $72,877; and 


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1 ‘‘(iii) the applicable inflation adjust2 ment under paragraph (2)(B) for the fiscal 

3 year for which the hiring goal was missed. 

4 ‘‘(C) HIRING GOALS.— 

5 ‘‘(i) IN GENERAL.—For purposes of 

6 subparagraph (B), the hiring goals for 

7 each of fiscal years 2023 through 2025 are 

8 as follows: 

9 ‘‘(I) For fiscal year 2023, 144 

10 hires. 

11 ‘‘(II) For fiscal year 2024, 42 

12 hires. 

13 ‘‘(III) For fiscal year 2025— 

14 ‘‘(aa) 24 hires if the base es15 tablishment registration fees are 

16 not increased by the amount de17 termined under paragraph 

18 (4)(A)(i); or 

19 ‘‘(bb) 83 hires if the base 

20 establishment registration fees 

21 are increased by the amount de22 termined under paragraph 

23 (4)(A)(i). 

24 ‘‘(ii) NUMBER OF HIRES.—For pur25 poses of this paragraph, the number of 


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1 hires for a fiscal year shall be determined 

2 by the Secretary, as set forth in the letters 

3 described in section 201(b) of the Medical 

4 Device User Fee Amendments of 2022. 

5 ‘‘(6) OPERATING RESERVE ADJUSTMENT.— 

6 ‘‘(A) IN GENERAL.—For each of fiscal 

7 years 2023 through 2027, after the adjust8 ments under paragraphs (3), (4), and (5), if ap9 plicable, if the Secretary has operating reserves 

10 of carryover user fees for the process for the re11 view of device applications in excess of the des12 ignated amount in subparagraph (B), the Sec13 retary shall decrease the base establishment 

14 registration fee amounts to provide for not 

15 more than such designated amount of operating 

16 reserves. 

17 ‘‘(B) DESIGNATED AMOUNT.—Subject to 

18 subparagraph (C), for each fiscal year, the des19 ignated amount in this subparagraph is equal 

20 to the sum of— 

21 ‘‘(i) 13 weeks of operating reserves of 

22 carryover user fees; and 

23 ‘‘(ii) the 1 month of operating re24 serves described in paragraph (8). 


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1 ‘‘(C) EXCLUDED AMOUNT.—For the period 

2 of fiscal years 2023 through 2026, a total 

3 amount equal to $118,000,000 shall not be con4 sidered part of the designated amount under 

5 subparagraph (B) and shall not be subject to 

6 the decrease under subparagraph (A).’’. 

7 (d) SMALL BUSINESSES.—Section 738 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend9 ed— 

10 (1) in subsection (d)(2)(B)(iii), by inserting ‘‘, 

11 if extant,’’ after ‘‘national taxing authority’’; and 

12 (2) in subsection (e)(2)(B)(iii), by inserting ‘‘, 

13 if extant,’’ after ‘‘national taxing authority’’. 

14 (e) CONDITIONS.—Section 738(g) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(g)) is 

16 amended— 

17 (1) in paragraph (1)(A), by striking 

18 ‘‘$320,825,000’’ and inserting ‘‘$398,566,000’’; and 

19 (2) in paragraph (2), by inserting ‘‘de novo 

20 classification requests,’’ after ‘‘class III device,’’. 

21 (f) AUTHORIZATION OF APPROPRIATIONS.—Section 

22 738(h)(3) of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 379j(h)(3)) is amended to read as follows: 

24 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 


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1 ‘‘(A) IN GENERAL.—For each of the fiscal 

2 years 2023 through 2027, there is authorized to 

3 be appropriated for fees under this section an 

4 amount equal to the revenue amount deter5 mined in subparagraph (B), less the amount of 

6 reductions determined in subparagraph (C). 

7 ‘‘(B) REVENUE AMOUNT.—For purposes of 

8 this paragraph, the revenue amount for each 

9 fiscal year is the sum of— 

10 ‘‘(i) the total revenue amount under 

11 subsection (b)(3) for the fiscal year, as ad12 justed under subsection (c)(2); and 

13 ‘‘(ii) the performance improvement 

14 adjustment amount for the fiscal year 

15 under subsection (c)(4)(A), if applicable. 

16 ‘‘(C) AMOUNT OF REDUCTIONS.—For pur17 poses of this paragraph, the amount of reduc18 tions for each fiscal year is the sum of— 

19 ‘‘(i) the hiring adjustment amount for 

20 the fiscal year under subsection (c)(5), if 

21 applicable; and 

22 ‘‘(ii) the operating reserve adjustment 

23 amount for the fiscal year under sub24 section (c)(6), if applicable.’’. 


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1 SEC. 204. ACCREDITATION PROGRAMS. 

2 (a) ACCREDITATION SCHEME FOR CONFORMITY AS3 SESSMENT.—Section 514(d) of the Federal Food, Drug, 

4 and Cosmetic Act (21 U.S.C. 360d(d)) is amended— 

5 (1) in the subsection heading, by striking 

6 ‘‘PILOT’’; 

7 (2) in paragraph (1)— 

8 (A) in the matter preceding subparagraph 

9 (A), by striking ‘‘pilot’’; 

10 (B) in subparagraph (A)— 

11 (i) by inserting ‘‘meeting criteria spec12 ified by the Secretary in guidance’’ after 

13 ‘‘testing laboratories’’; 

14 (ii) by inserting ‘‘in guidance’’ after 

15 ‘‘by the Secretary’’; and 

16 (iii) by striking ‘‘assess the conform17 ance of a device with’’ and inserting ‘‘con18 duct testing to support the assessment of 

19 the conformance of a device to’’; and 

20 (C) in subparagraph (B)— 

21 (i) by striking ‘‘determinations’’ and 

22 inserting ‘‘results’’; 

23 (ii) by inserting ‘‘to support’’ after 

24 ‘‘so accredited’’; and 


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1 (iii) by striking ‘‘a particular such de2 termination’’ and inserting ‘‘particular 

3 such results’’; 

4 (3) in paragraph (2)— 

5 (A) in the paragraph heading, by striking 

6 ‘‘DETERMINATIONS’’ and inserting ‘‘RESULTS’’; 

7 (B) in subparagraph (A)— 

8 (i) by striking ‘‘determinations by 

9 testing laboratories’’ and all that follows 

10 through ‘‘such determinations or’’ and in11 serting ‘‘results by testing laboratories ac12 credited pursuant to this subsection, in13 cluding by conducting periodic audits of 

14 such results or of the’’; 

15 (ii) by inserting a comma after ‘‘or 

16 testing laboratories’’; 

17 (iii) by inserting ‘‘or recognition of an 

18 accreditation body’’ after ‘‘accreditation of 

19 such testing laboratory’’; and 

20 (iv) by striking ‘‘such device’’ and in21 serting ‘‘a device’’; and 

22 (C) in subparagraph (B)— 

23 (i) by striking ‘‘by a testing labora24 tory so accredited’’ and inserting ‘‘under 

25 this subsection’’; and 


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1 (ii) by inserting ‘‘or recognition of an 

2 accreditation body’’ before ‘‘under para3 graph (1)(A)’’; 

4 (4) in paragraph (3)(C)— 

5 (A) in the subparagraph heading, by in6 serting ‘‘AND TRANSITION’’ after ‘‘INITIATION’’; 

7 and 

8 (B) by adding at the end the following: 

9 ‘‘After September 30, 2023, such pilot program 

10 will be considered to be completed, and the Sec11 retary shall have the authority to continue oper12 ating a program consistent with this sub13 section.’’; and 

14 (5) by striking paragraph (4). 

15 (b) ACCREDITED PERSONS.—Section 523(c) of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 360m(c)) is amended by striking ‘‘2022’’ and inserting 

18 ‘‘2027’’. 

19 SEC. 205. SUNSET DATES. 

20 (a) AUTHORIZATION.—Sections 737 and 738 of the 

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 

22 379fj) shall cease to be effective October 1, 2027. 

23 (b) REPORTING REQUIREMENTS.—Section 738A of 

24 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

25 379j–1) shall cease to be effective January 31, 2028. 


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1 (c) PREVIOUS SUNSET PROVISION.—Effective Octo2 ber 1, 2022, subsections (a) and (b) of section 210 of the 

3 FDA Reauthorization Act of 2017 (Public Law 115–52) 

4 are repealed. 

5 SEC. 206. EFFECTIVE DATE. 

6 The amendments made by this title shall take effect 

7 on October 1, 2022, or the date of the enactment of this 

8 Act, whichever is later, except that fees under part 3 of 

9 subchapter C of chapter VII of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 379i et seq.) shall be as11 sessed for all submissions listed in section 738(a)(2)(A) 

12 of such Act received on or after October 1, 2022, regard13 less of the date of the enactment of this Act. 

14 SEC. 207. SAVINGS CLAUSE. 

15 Notwithstanding the amendments made by this title, 

16 part 3 of subchapter C of chapter VII of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in 

18 effect on the day before the date of the enactment of this 

19 title, shall continue to be in effect with respect to the sub20 missions listed in section 738(a)(2)(A) of such Act (as de21 fined in such part as of such day) that on or after October 

22 1, 2017, but before October 1, 2022, were received by the 

23 Food and Drug Administration with respect to assessing 

24 and collecting any fee required by such part for a fiscal 

25 year prior to fiscal year 2023. 


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1 TITLE III—FEES RELATING TO 

2 GENERIC DRUGS 

3 SEC. 301. SHORT TITLE; FINDING. 

4 (a) SHORT TITLE.—This title may be cited as the 

5 ‘‘Generic Drug User Fee Amendments of 2022’’. 

6 (b) FINDING.—The Congress finds that the fees au7 thorized by the amendments made in this title will be dedi8 cated to human generic drug activities, as set forth in the 

9 goals identified for purposes of part 7 of subchapter C 

10 of chapter VII of the Federal Food, Drug, and Cosmetic 

11 Act, in the letters from the Secretary of Health and 

12 Human Services to the Chairman of the Committee on 

13 Health, Education, Labor, and Pensions of the Senate and 

14 the Chairman of the Committee on Energy and Commerce 

15 of the House of Representatives, as set forth in the Con16 gressional Record. 

17 SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE18 NERIC DRUG FEES. 

19 (a) TYPES OF FEES.—Section 744B(a) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

21 42(a)) is amended— 

22 (1) in the matter preceding paragraph (1), by 

23 striking ‘‘2018’’ and inserting ‘‘2023’’; 


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1 (2) in paragraph (2)(C), by striking ‘‘fiscal 

2 years 2018 through 2022’’ and inserting ‘‘fiscal 

3 years 2023 through 2027’’; 

4 (3) in paragraph (3)(B), by striking ‘‘fiscal 

5 years 2018 through 2022’’ and inserting ‘‘fiscal 

6 years 2023 through 2027’’; 

7 (4) in paragraph (4)(D), by striking ‘‘fiscal 

8 years 2018 through 2022’’ and inserting ‘‘fiscal 

9 years 2023 through 2027’’; and 

10 (5) in paragraph (5)(D), by striking ‘‘fiscal 

11 years 2018 through 2022’’ and inserting ‘‘fiscal 

12 years 2023 through 2027’’. 

13 (b) FEE REVENUE AMOUNTS.—Section 744B(b) of 

14 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 379j–42(b)) is amended— 

16 (1) in paragraph (1)— 

17 (A) in subparagraph (A)— 

18 (i) in the heading, by striking ‘‘2018’’ 

19 and inserting ‘‘2023’’; 

20 (ii) by striking ‘‘2018’’ and inserting 

21 ‘‘2023’’; and 

22 (iii) by striking ‘‘$493,600,000’’ and 

23 inserting ‘‘$582,500,000’’; and 

24 (B) in subparagraph (B)— 


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1 (i) in the heading, by striking ‘‘2019

2 THROUGH 2022’’ and inserting ‘‘2024

3 THROUGH 2027’’; 

4 (ii) by striking ‘‘For each’’ and insert5 ing the following: 

6 ‘‘(i) IN GENERAL.—For each’’; 

7 (iii) by striking ‘‘2019 through 2022’’ 

8 and inserting ‘‘2024 through 2027’’; 

9 (iv) by striking ‘‘$493,600,000’’ and 

10 inserting ‘‘the base revenue amount under 

11 clause (ii)’’; and 

12 (v) by adding at the end the following: 

13 ‘‘(ii) BASE REVENUE AMOUNT.—The 

14 base revenue amount for a fiscal year is 

15 the total revenue amount established under 

16 this paragraph for the previous fiscal year, 

17 not including any adjustments made for 

18 such previous fiscal year under subsection 

19 (c)(3).’’; and 

20 (2) in paragraph (2)— 

21 (A) in subparagraph (C), by striking ‘‘one22 third the amount’’ and inserting ‘‘24 percent’’; 

23 (B) in subparagraph (D), by striking 

24 ‘‘Seven’’ and inserting ‘‘Six’’; and 


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1 (C) in subparagraph (E)(i), by striking 

2 ‘‘Thirty-five’’ and inserting ‘‘Thirty-six’’. 

3 (c) ADJUSTMENTS.—Section 744B(c) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is 

5 amended— 

6 (1) in paragraph (1)— 

7 (A) in the matter preceding subparagraph 

8 (A)— 

9 (i) by striking ‘‘2019’’ and inserting 

10 ‘‘2024’’; and 

11 (ii) by striking ‘‘the product of the 

12 total revenues established in such notice 

13 for the prior fiscal year’’ and inserting 

14 ‘‘the base revenue amount for the fiscal 

15 year determined under subsection 

16 (b)(1)(B)(ii)’’; and 

17 (B) in subparagraph (C), by striking 

18 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ 

19 and inserting ‘‘Washington-Arlington-Alexan20 dria, DC–VA–MD–WV’’; and 

21 (2) by striking paragraph (2) and inserting the 

22 following: 

23 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

24 ‘‘(A) IN GENERAL.—Beginning with fiscal 

25 year 2024, the Secretary shall, in addition to 


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1 the adjustment under paragraph (1), further in2 crease the fee revenue and fees under this sec3 tion for a fiscal year, in accordance with this 

4 paragraph, to reflect changes in the resource 

5 capacity needs of the Secretary for human ge6 neric drug activities. 

7 ‘‘(B) CAPACITY PLANNING METHOD8 OLOGY.—The Secretary shall establish a capac9 ity planning methodology for purposes of this 

10 paragraph, which shall— 

11 ‘‘(i) be derived from the methodology 

12 and recommendations made in the report 

13 titled ‘Independent Evaluation of the 

14 GDUFA Resource Capacity Planning Ad15 justment Methodology: Evaluation and 

16 Recommendations’ as announced in the 

17 Federal Register on August 3, 2020 (85 

18 Fed. Reg. 46658); and 

19 ‘‘(ii) incorporate approaches and at20 tributes determined appropriate by the 

21 Secretary, including those made in such re22 port recommendations, except the workload 

23 categories used in forecasting resources 

24 shall only be those specified in section 

25 VIII.B.2.e. of the letters described in secVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 tion 301(b) of the Generic Drug User Fee 

2 Amendments of 2022. 

3 ‘‘(C) LIMITATIONS.— 

4 ‘‘(i) IN GENERAL.—Under no cir5 cumstances shall an adjustment under this 

6 paragraph result in fee revenue for a fiscal 

7 year that is less than the sum of the 

8 amounts under subsection (b)(1)(B)(ii) 

9 (the base revenue amount for the fiscal 

10 year) and paragraph (1) (the dollar 

11 amount of the inflation adjustment for the 

12 fiscal year). 

13 ‘‘(ii) ADDITIONAL LIMITATION.—An 

14 adjustment under this paragraph shall not 

15 exceed 3 percent of the sum described in 

16 clause (i) for the fiscal year, except that 

17 such limitation shall be 4 percent if— 

18 ‘‘(I) for purposes of an adjust19 ment for fiscal year 2024, the Sec20 retary determines that, during the pe21 riod from April 1, 2021, through 

22 March 31, 2023— 

23 ‘‘(aa) the total number of 

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1 tions submitted was greater than 

2 or equal to 2,000; or 

3 ‘‘(bb) thirty-five percent or 

4 more of abbreviated new drug ap5 plications submitted related to 

6 complex products (as that term is 

7 defined in section XI of the let8 ters described in section 301(b) 

9 of the Generic Drug User Fee 

10 Amendments of 2022); 

11 ‘‘(II) for purposes of an adjust12 ment for fiscal year 2025, the Sec13 retary determines that, during the pe14 riod from April 1, 2022, through 

15 March 31, 2024— 

16 ‘‘(aa) the total number of 

17 abbreviated new drug applica18 tions submitted was greater than 

19 or equal to 2,300; or 

20 ‘‘(bb) thirty-five percent or 

21 more of abbreviated new drug ap22 plications submitted related to 

23 complex products (as so defined); 

24 ‘‘(III) for purposes of an adjust25 ment for fiscal year 2026, the SecVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 retary determines that, during the pe2 riod from April 1, 2023, through 

3 March 31, 2025— 

4 ‘‘(aa) the total number of 

5 abbreviated new drug applica6 tions submitted was greater than 

7 or equal to 2,300; or 

8 ‘‘(bb) thirty-five percent or 

9 more of abbreviated new drug ap10 plications submitted related to 

11 complex products (as so defined); 

12 and 

13 ‘‘(IV) for purposes of an adjust14 ment for fiscal year 2027, the Sec15 retary determines that, during the pe16 riod from April 1, 2024, through 

17 March 31, 2026— 

18 ‘‘(aa) the total number of 

19 abbreviated new drug applica20 tions submitted was greater than 

21 or equal to 2,300; or 

22 ‘‘(bb) thirty-five percent or 

23 more of abbreviated new drug ap24 plications submitted related to 

25 complex products (as so defined). 


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1 ‘‘(D) PUBLICATION IN FEDERAL REG2 ISTER.—The Secretary shall publish in the Fed3 eral Register notice under subsection (a), the 

4 fee revenue and fees resulting from the adjust5 ment and the methodology under this para6 graph. 

7 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

8 ‘‘(A) IN GENERAL.—For fiscal year 2024 

9 and subsequent fiscal years, the Secretary may, 

10 in addition to adjustments under paragraphs 

11 (1) and (2), further increase the fee revenue 

12 and fees under this section if such an adjust13 ment is necessary to provide operating reserves 

14 of carryover user fees for human generic drug 

15 activities for not more than the number of 

16 weeks specified in subparagraph (B). 

17 ‘‘(B) NUMBER OF WEEKS.—The number of 

18 weeks specified in this subparagraph is— 

19 ‘‘(i) 8 weeks for fiscal year 2024; 

20 ‘‘(ii) 9 weeks for fiscal year 2025; and 

21 ‘‘(iii) 10 weeks for each of fiscal year 

22 2026 and 2027. 

23 ‘‘(C) DECREASE.—If the Secretary has 

24 carryover balances for human generic drug ac25 tivities in excess of 12 weeks of the operating 


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1 reserves referred to in subparagraph (A), the 

2 Secretary shall decrease the fee revenue and 

3 fees referred to in such subparagraph to provide 

4 for not more than 12 weeks of such operating 

5 reserves. 

6 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If 

7 an adjustment under this paragraph is made, 

8 the rationale for the amount of the increase or 

9 decrease (as applicable) in fee revenue and fees 

10 shall be contained in the annual Federal Reg11 ister notice under subsection (a) publishing the 

12 fee revenue and fees for the fiscal year in13 volved.’’. 

14 (d) ANNUAL FEE SETTING.—Section 744B(d)(1) of 

15 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 379j–42(d)(1)) is amended— 

17 (1) in the heading, by striking ‘‘2018 THROUGH

18 2022’’ and inserting ‘‘2023 THROUGH 2027’’; 

19 (2) by striking ‘‘more’’ and inserting ‘‘later’’; 

20 and 

21 (3) by striking ‘‘2018 through 2022’’ and in22 serting ‘‘2023 through 2027’’. 

23 (e) EFFECT OF FAILURE TO PAY FEES.—The head24 ing of paragraph (3) of section 744B(g) of the Federal 

25 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(g)) is 


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1 amended by striking ‘‘AND PRIOR APPROVAL SUPPLEMENT

2 FEE’’. 

3 (f) CREDITING AND AVAILABILITY OF FEES.—Sec4 tion 744B(i)(3) of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 379j–42(i)(3)) is amended by striking 

6 ‘‘2018 through 2022’’ and inserting ‘‘2023 through 

7 2027’’. 

8 SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 

9 Section 744C of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 379j–43) is amended— 

11 (1) in subsection (a)— 

12 (A) by striking ‘‘2018’’ each place it ap13 pears and inserting ‘‘2023’’; and 

14 (B) by striking ‘‘Generic Drug User Fee 

15 Amendments of 2017’’ each place it appears 

16 and inserting ‘‘Generic Drug User Fee Amend17 ments of 2022’’; 

18 (2) in subsection (b), by striking ‘‘2018’’ and 

19 inserting ‘‘2023’’; 

20 (3) in subsection (c)— 

21 (A) by striking ‘‘2018’’ and inserting 

22 ‘‘2023’’; and 

23 (B) by striking ‘‘Generic Drug User Fee 

24 Amendments of 2017’’ each place it appears 


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1 and inserting ‘‘Generic Drug User Fee Amend2 ments of 2022’’; and 

3 (4) in subsection (f)— 

4 (A) in paragraph (1), by striking ‘‘2022’’ 

5 and inserting ‘‘2027’’; and 

6 (B) in paragraph (5), by striking ‘‘January 

7 15, 2022’’ and inserting ‘‘January 15, 2027’’. 

8 SEC. 304. SUNSET DATES. 

9 (a) AUTHORIZATION.—Sections 744A and 744B of 

10 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 379j–41; 379j–42) shall cease to be effective October 1, 

12 2027. 

13 (b) REPORTING REQUIREMENTS.—Section 744C of 

14 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 379j–43) shall cease to be effective January 31, 2028. 

16 (c) PREVIOUS SUNSET PROVISION.—Effective Octo17 ber 1, 2022, subsections (a) and (b) of section 305 of the 

18 FDA Reauthorization Act of 2017 (Public Law 115–52) 

19 are repealed. 

20 SEC. 305. EFFECTIVE DATE. 

21 The amendments made by this title shall take effect 

22 on October 1, 2022, or the date of the enactment of this 

23 Act, whichever is later, except that fees under part 7 of 

24 subchapter C of chapter VII of the Federal Food, Drug, 

25 and Cosmetic Act shall be assessed for all abbreviated new 


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1 drug applications received on or after October 1, 2022, 

2 regardless of the date of the enactment of this Act. 

3 SEC. 306. SAVINGS CLAUSE. 

4 Notwithstanding the amendments made by this title, 

5 part 7 of subchapter C of chapter VII of the Federal Food, 

6 Drug, and Cosmetic Act, as in effect on the day before 

7 the date of the enactment of this title, shall continue to 

8 be in effect with respect to abbreviated new drug applica9 tions (as defined in such part as of such day) that were 

10 received by the Food and Drug Administration within the 

11 meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 

12 355(j)(5)(A)), prior approval supplements that were sub13 mitted, and drug master files for Type II active pharma14 ceutical ingredients that were first referenced on or after 

15 October 1, 2017, but before October 1, 2022, with respect 

16 to assessing and collecting any fee required by such part 

17 for a fiscal year prior to fiscal year 2023. 

18 TITLE IV—FEES RELATING TO 

19 BIOSIMILAR BIOLOGICAL 

20 PRODUCTS 

21 SEC. 401. SHORT TITLE; FINDING. 

22 (a) SHORT TITLE.—This title may be cited as the 

23 ‘‘Biosimilar User Fee Amendments of 2022’’. 

24 (b) FINDING.—Congress finds that the fees author25 ized by the amendments made in this title will be dediVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 cated to expediting the process for the review of biosimilar 

2 biological product applications, including postmarket safe3 ty activities, as set forth in the goals identified for pur4 poses of part 8 of subchapter C of chapter VII of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 

6 et seq.), in the letters from the Secretary of Health and 

7 Human Services to the Chairman of the Committee on 

8 Health, Education, Labor, and Pensions of the Senate and 

9 the Chairman of the Committee on Energy and Commerce 

10 of the House of Representatives, as set forth in the Con11 gressional Record. 

12 SEC. 402. DEFINITIONS. 

13 Section 744G of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 379j–51) is amended— 

15 (1) in paragraph (1)— 

16 (A) by striking ‘‘Washington-Baltimore, 

17 DC–MD–VA–WV’’ and inserting ‘‘Washington– 

18 Arlington–Alexandria, DC–VA–MD–WV’’; 

19 (B) by striking ‘‘October of’’ and inserting 

20 ‘‘September of’’; and 

21 (C) by striking ‘‘October 2011’’ and insert22 ing ‘‘September 2011’’; and 

23 (2) in paragraph (4)(B)(iii)— 

24 (A) by striking subclause (II); and 


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1 (B) by redesignating subclauses (III) and 

2 (IV) as subclauses (II) and (III), respectively. 

3 SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIO4 LOGICAL PRODUCT FEES. 

5 (a) TYPES OF FEES.—Section 744H(a) of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

7 52(a)) is amended— 

8 (1) in the matter preceding paragraph (1), by 

9 striking ‘‘2018’’ and inserting ‘‘2023’’; 

10 (2) in paragraph (1)— 

11 (A) in subparagraph (A)— 

12 (i) in clause (iv)(I), by striking ‘‘5 

13 days’’ and inserting ‘‘7 days’’; and 

14 (ii) in clause (v)(II), by striking ‘‘5 

15 days’’ and inserting ‘‘7 days’’; 

16 (B) in subparagraph (B)— 

17 (i) in clause (i), by inserting ‘‘except 

18 that, in the case that such product (includ19 ing, where applicable, ownership of the rel20 evant investigational new drug application) 

21 is transferred to a licensee, assignee, or 

22 successor of such person, and written no23 tice of such transfer is provided to the Sec24 retary, such licensee, assignee or successor 

25 shall pay the annual biosimilar biological 


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1 product development fee’’ before the pe2 riod; 

3 (ii) in clause (iii)— 

4 (I) in subclause (I), by striking 

5 ‘‘; or’’ and inserting a semicolon; 

6 (II) in subclause (II), by striking 

7 the period and inserting ‘‘; or’’; and 

8 (III) by adding at the end the 

9 following: 

10 ‘‘(III) been administratively re11 moved from the biosimilar biological 

12 product development program for the 

13 product under subparagraph (E)(v).’’; 

14 and 

15 (iii) in clause (iv), by striking ‘‘accept16 ed for filing on or after October 1 of such 

17 fiscal year’’ and inserting ‘‘subsequently 

18 accepted for filing’’; 

19 (C) in subparagraph (D)— 

20 (i) in clause (i)— 

21 (I) in the matter preceding sub22 clause (I), by striking ‘‘shall, if the 

23 person seeks to resume participation 

24 in such program, pay’’ and inserting 

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1 moved from such program for a prod2 uct under subparagraph (E)(v) shall, 

3 if the person seeks to resume partici4 pation in such program, pay all an5 nual biosimilar biological product de6 velopment fees previously assessed for 

7 such product and still owed and’’; 

8 (II) in subclause (I)— 

9 (aa) by striking ‘‘5 days’’ 

10 and inserting ‘‘7 days’’; and 

11 (bb) by inserting ‘‘or the 

12 date of administrative removal, 

13 as applicable’’ after ‘‘discon14 tinued’’; and 

15 (III) in subclause (II), by insert16 ing ‘‘or the date of administrative re17 moval, as applicable’’ after ‘‘discon18 tinued’’; and 

19 (ii) in clause (ii), by inserting ‘‘except 

20 that, in the case that such product (includ21 ing, where applicable, ownership of the rel22 evant investigational new drug application) 

23 is transferred to a licensee, assignee, or 

24 successor of such person, and written no25 tice of such transfer is provided to the SecVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 retary, such licensee, assignee or successor 

2 shall pay the annual biosimilar biological 

3 product development fee’’ before the period 

4 at the end; and 

5 (D) in subparagraph (E), by adding at the 

6 end the following: 

7 ‘‘(v) ADMINISTRATIVE REMOVAL FROM

8 THE BIOSIMILAR BIOLOGICAL PRODUCT

9 DEVELOPMENT PROGRAM.—If a person has 

10 failed to pay an annual biosimilar biologi11 cal product development fee for a product 

12 as required under subparagraph (B) for a 

13 period of 2 consecutive fiscal years, the 

14 Secretary may administratively remove 

15 such person from the biosimilar biological 

16 product development program for the prod17 uct. At least 30 days prior to administra18 tively removing a person from the bio19 similar biological product development pro20 gram for a product under this clause, the 

21 Secretary shall provide written notice to 

22 such person of the intended administrative 

23 removal.’’; 

24 (3) in paragraph (2)(D), by inserting ‘‘prior to 

25 approval’’ after ‘‘withdrawn’’; 


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1 (4) in paragraph (3)— 

2 (A) in subparagraph (A)— 

3 (i) in clause (i), by striking ‘‘; and’’ 

4 and inserting a semicolon; 

5 (ii) by redesignating clause (ii) as 

6 clause (iii); and 

7 (iii) by inserting the following after 

8 clause (i): 

9 ‘‘(ii) may be dispensed only under pre10 scription pursuant to section 503(b); and’’; 

11 and 

12 (B) by adding at the end the following: 

13 ‘‘(E) MOVEMENT TO DISCONTINUED

14 LIST.— 

15 ‘‘(i) WRITTEN REQUEST TO PLACE ON

16 DISCONTINUED LIST.— 

17 ‘‘(I) IN GENERAL.—If a written 

18 request to place a product on the list 

19 of discontinued biosimilar biological 

20 products referred to in subparagraph 

21 (A)(iii) is submitted to the Secretary 

22 on behalf of an applicant, and the re23 quest identifies the date the product 

24 is, or will be, withdrawn from sale, 

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1 similar biological product program fee, 

2 the Secretary shall consider such 

3 product to have been included on such 

4 list on the later of— 

5 ‘‘(aa) the date such request 

6 was received; or 

7 ‘‘(bb) if the product will be 

8 withdrawn from sale on a future 

9 date, such future date when the 

10 product is withdrawn from sale. 

11 ‘‘(II) WITHDRAWN FROM SALE

12 DEFINED.—For purposes of this 

13 clause, a product shall be considered 

14 withdrawn from sale once the appli15 cant has ceased its own distribution of 

16 the product, whether or not the appli17 cant has ordered recall of all pre18 viously distributed lots of the product, 

19 except that a routine, temporary 

20 interruption in supply shall not render 

21 a product withdrawn from sale. 

22 ‘‘(ii) PRODUCTS REMOVED FROM DIS23 CONTINUED LIST.—If a biosimilar biologi24 cal product that is identified in a bio25 similar biological product application apVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 proved as of October 1 of a fiscal year ap2 pears, as of October 1 of such fiscal year, 

3 on the list of discontinued biosimilar bio4 logical products referred to in subpara5 graph (A)(iii), and on any subsequent day 

6 during such fiscal year the biosimilar bio7 logical product does not appear on such 

8 list, except as provided in subparagraph 

9 (D), each person who is named as the ap10 plicant in the biosimilar biological product 

11 application shall pay the annual biosimilar 

12 biological product program fee established 

13 for a fiscal year under subsection (c)(5) for 

14 such biosimilar biological product. Not15 withstanding subparagraph (B), such fee 

16 shall be due on the last business day of 

17 such fiscal year and shall be paid only once 

18 for each product for each fiscal year.’’; and 

19 (5) by striking paragraph (4). 

20 (b) FEE REVENUE AMOUNTS.—Section 744H(b) of 

21 the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 

22 379j–52(b)) is amended— 

23 (1) by striking paragraph (1); 

24 (2) by redesignating paragraphs (2) through 

25 (4) as paragraphs (1) through (3), respectively; 


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1 (3) in paragraph (1), as so redesignated— 

2 (A) in the paragraph heading, by striking 

3 ‘‘SUBSEQUENT FISCAL YEARS’’ and inserting 

4 ‘‘IN GENERAL’’; 

5 (B) in the matter preceding subparagraph 

6 (A), by striking ‘‘2019 through 2022’’ and in7 serting ‘‘2023 through 2027’’; 

8 (C) in subparagraph (A), by striking 

9 ‘‘paragraph (4)’’ and inserting ‘‘paragraph 

10 (3)’’; 

11 (D) by redesignating subparagraphs (C) 

12 and (D) as subparagraphs (D) and (E), respec13 tively; 

14 (E) by inserting after subparagraph (B) 

15 the following: 

16 ‘‘(C) the dollar amount equal to the stra17 tegic hiring and retention adjustment (as deter18 mined under subsection (c)(2));’’; 

19 (F) in subparagraph (D), as so redesig20 nated, by striking ‘‘subsection (c)(2)); and’’ and 

21 inserting ‘‘subsection (c)(3));’’; 

22 (G) in subparagraph (E), as so redesig23 nated, by striking ‘‘subsection (c)(3)).’’ and in24 serting ‘‘subsection (c)(4)); and’’; and 

25 (H) by adding at the end the following: 


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1 ‘‘(F) for fiscal years 2023 and 2024, addi2 tional dollar amounts equal to— 

3 ‘‘(i) $4,428, 886 for fiscal year 2023; 

4 and 

5 ‘‘(ii) $320,569 for fiscal year 2024.’’; 

6 (4) in paragraph (2), as so redesignated— 

7 (A) in the paragraph heading, by striking 

8 ‘‘; LIMITATIONS ON FEE AMOUNTS’’; 

9 (B) by striking subparagraph (B); and 

10 (C) by redesignating subaparagraphs (C) 

11 and (D) as subparagraphs (B) and (C), respec12 tively; and 

13 (5) by amending paragraph (3), as so redesig14 nated, to read as follows: 

15 ‘‘(3) ANNUAL BASE REVENUE.—For purposes 

16 of paragraph (1), the dollar amount of the annual 

17 base revenue for a fiscal year shall be— 

18 ‘‘(A) for fiscal year 2023, $43,376,922; 

19 and 

20 ‘‘(B) for fiscal years 2024 through 2027, 

21 the dollar amount of the total revenue amount 

22 established under paragraph (1) for the pre23 vious fiscal year, excluding any adjustments to 

24 such revenue amount under subsection (c)(4).’’. 


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1 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 

2 744H(c) of the Federal Food, Drug, and Cosmetic Act 

3 ((21 U.S.C. 379j–52(c)) is amended— 

4 (1) in paragraph (1)— 

5 (A) in subparagraph (A)— 

6 (i) in the matter preceding clause (i), 

7 by striking ‘‘subsection (b)(2)(B)’’ and in8 serting ‘‘subsection (b)(1)(B)’’; and 

9 (ii) in clause (i), by striking ‘‘sub10 section (b)’’ and inserting ‘‘subsection 

11 (b)(1)(A)’’; and 

12 (B) in subparagraph (B)(ii), by striking 

13 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ 

14 and inserting ‘‘Washington–Arlington–Alexan15 dria, DC–VA–MD–WV’’; 

16 (2) by striking paragraph (4); 

17 (3) by redesignating paragraphs (2) and (3) as 

18 paragraphs (3) and (4), respectively; 

19 (4) by inserting after paragraph (1) the fol20 lowing: 

21 ‘‘(2) STRATEGIC HIRING AND RETENTION AD22 JUSTMENT.—For each fiscal year beginning in fiscal 

23 year 2023, after the annual base revenue under sub24 section (b)(1)(A) is adjusted for inflation in accordVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00063 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 ance with paragraph (1), the Secretary shall further 

2 increase the fee revenue and fees by $150,000.’’; 

3 (5) in paragraph (3), as so redesignated— 

4 (A) in subparagraph (A)— 

5 (i) by striking ‘‘Beginning with the 

6 fiscal year described in subparagraph 

7 (B)(ii)(II)’’ and inserting ‘‘For each fiscal 

8 year’’; and 

9 (ii) by striking ‘‘adjustment under 

10 paragraph (1), further increase’’ and in11 serting ‘‘adjustments under paragraphs (1) 

12 and (2), further adjust’’; and 

13 (B) by amending subparagraph (B) to read 

14 as follows: 

15 ‘‘(B) METHODOLOGY.—For purposes of 

16 this paragraph, the Secretary shall employ the 

17 capacity planning methodology utilized by the 

18 Secretary in setting fees for fiscal year 2021, as 

19 described in the notice titled ‘Biosimilar User 

20 Fee Rates for Fiscal Year 2021’ (85 Fed. Reg. 

21 47220; August 4, 2020). The workload cat22 egories used in forecasting shall include only 

23 the activities described in such notice and, as 

24 feasible, additional activities that are also di25 rectly related to the direct review of biosimilar 


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1 biological product applications and supplements, 

2 including additional formal meeting types and 

3 the direct review of postmarketing commitments 

4 and requirements, the direct review of risk eval5 uation and mitigation strategies, and the direct 

6 review of annual reports for approved biosimilar 

7 biological products. Subject to the exceptions in 

8 the preceding sentence, the Secretary shall not 

9 include as workload categories in forecasting 

10 any non-core review activities, including any ac11 tivities that the Secretary referenced for poten12 tial future use in such notice but did not utilize 

13 in setting fees for fiscal year 2021.’’; and 

14 (C) in subparagraph (C)— 

15 (i) by striking ‘‘subsections (b)(2)(A)’’ 

16 and inserting ‘‘subsections (b)(1)(A)’’; 

17 (ii) by striking ‘‘and (b)(2)(B)’’ and 

18 inserting ‘‘, (b)(1)(B)’’; and 

19 (iii) by inserting ‘‘, and (b)(1)(C) (the 

20 dollar amount of the strategic hiring and 

21 retention adjustment)’’ before the period at 

22 the end; 

23 (6) by amending paragraph (4), as so redesig24 nated, to read as follows: 

25 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 


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1 ‘‘(A) INCREASE.—For fiscal year 2023 and 

2 subsequent fiscal years, the Secretary shall, in 

3 addition to adjustments under paragraphs (1), 

4 (2), and (3), further increase the fee revenue 

5 and fees if such an adjustment is necessary to 

6 provide for at least 10 weeks of operating re7 serves of carryover user fees for the process for 

8 the review of biosimilar biological product appli9 cations. 

10 ‘‘(B) DECREASE.— 

11 ‘‘(i) FISCAL YEAR 2023.—For fiscal 

12 year 2023, if the Secretary has carryover 

13 balances for the process for the review of 

14 biosimilar biological product applications in 

15 excess of 33 weeks of such operating re16 serves, the Secretary shall decrease such 

17 fee revenue and fees to provide for not 

18 more than 33 weeks of such operating re19 serves. 

20 ‘‘(ii) FISCAL YEAR 2024.—For fiscal 

21 year 2024, if the Secretary has carryover 

22 balances for the process for the review of 

23 biosimilar biological product applications in 

24 excess of 27 weeks of such operating re25 serves, the Secretary shall decrease such 


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1 fee revenue and fees to provide for not 

2 more than 27 weeks of such operating re3 serves. 

4 ‘‘(iii) FISCAL YEAR 2025 AND SUBSE5 QUENT FISCAL YEARS.—For fiscal year 

6 2025 and subsequent fiscal years, if the 

7 Secretary has carryover balances for the 

8 process for the review of biosimilar biologi9 cal product applications in excess of 21 

10 weeks of such operating reserves, the Sec11 retary shall decrease such fee revenue and 

12 fees to provide for not more than 21 weeks 

13 of such operating reserves. 

14 ‘‘(C) FEDERAL REGISTER NOTICE.—If an 

15 adjustment under subparagraph (A) or (B) is 

16 made, the rationale for the amount of the in17 crease or decrease (as applicable) in fee revenue 

18 and fees shall be contained in the annual Fed19 eral Register notice under paragraph (5)(B) es20 tablishing fee revenue and fees for the fiscal 

21 year involved.’’; and 

22 (7) in paragraph (5), in the matter preceding 

23 subparagraph (A), by striking ‘‘2018’’ and inserting 

24 ‘‘2023’’. 


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1 (d) CREDITING AND AVAILABILITY OF FEES.—Sec2 tion 744H(f)(3) of the Federal Food, Drug, and Cosmetic 

3 Act ((21 U.S.C. 379j–52(f)(3)) is amended by striking 

4 ‘‘2018 through 2022’’ and inserting ‘‘2023 through 

5 2027’’. 

6 (e) WRITTEN REQUESTS FOR WAIVERS AND RE7 FUNDS.—Subsection (h) of section 744H of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52) is 

9 amended to read as follows: 

10 ‘‘(h) WRITTEN REQUESTS FOR WAIVERS AND RE11 TURNS; DISPUTES CONCERNING FEES.—To qualify for 

12 consideration for a waiver under subsection (d), or the re13 turn of any fee paid under this section, including if the 

14 fee is claimed to have been paid in error, a person shall 

15 submit to the Secretary a written request justifying such 

16 waiver or return and, except as otherwise specified in this 

17 section, such written request shall be submitted to the Sec18 retary not later than 180 days after such fee is due. A 

19 request submitted under this paragraph shall include any 

20 legal authorities under which the request is made.’’. 

21 SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 

22 Section 744I of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 379j–53) is amended— 

24 (1) by striking ‘‘2018’’ each place it appears 

25 and inserting ‘‘2023’’; 


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1 (2) by striking ‘‘Biosimilar User Fee Amend2 ments of 2017’’ each place it appears and inserting 

3 ‘‘Biosimilar User Fee Amendments of 2022’’; 

4 (3) in subsection (a)(4), by striking ‘‘2020’’ and 

5 inserting ‘‘2023’’; and 

6 (4) in subsection (f), by striking ‘‘2022’’ each 

7 place it appears and inserting ‘‘2027’’. 

8 SEC. 405. SUNSET DATES. 

9 (a) AUTHORIZATION.—Sections 744G and 744H of 

10 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 379j–51, 379j–52 ) shall cease to be effective October 1, 

12 2027. 

13 (b) REPORTING REQUIREMENTS.—Section 744I of 

14 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 379j–53) shall cease to be effective January 31, 2028. 

16 (c) PREVIOUS SUNSET PROVISION.—Effective Octo17 ber 1, 2022, subsections (a) and (b) of section 405 of the 

18 FDA Reauthorization Act of 2017 (Public Law 115–52) 

19 are repealed. 

20 SEC. 406. EFFECTIVE DATE. 

21 The amendments made by this title shall take effect 

22 on October 1, 2022, or the date of the enactment of this 

23 Act, whichever is later, except that fees under part 8 of 

24 subchapter C of chapter VII of the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be 


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1 assessed for all biosimilar biological product applications 

2 received on or after October 1, 2022, regardless of the 

3 date of the enactment of this Act. 

4 SEC. 407. SAVINGS CLAUSE. 

5 Notwithstanding the amendments made by this title, 

6 part 8 of subchapter C of chapter VII of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), as 

8 in effect on the day before the date of the enactment of 

9 this title, shall continue to be in effect with respect to bio10 similar biological product applications and supplements 

11 (as defined in such part as of such day) that were accepted 

12 by the Food and Drug Administration for filing on or after 

13 October 1, 2017, but before October 1, 2022, with respect 

14 to assessing and collecting any fee required by such part 

15 for a fiscal year prior to fiscal year 2023. 

16 TITLE V—IMPROVING REGULA17 TION OF DRUGS AND BIO18 LOGICAL PRODUCTS 

19 SEC. 501. ALTERNATIVES TO ANIMAL TESTING. 

20 (a) IN GENERAL.—Section 505 of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 

22 (1) in subsection (i)— 

23 (A) in paragraph (1)(A), by striking ‘‘pre24 clinical tests (including tests on animals)’’ and 

25 inserting ‘‘nonclinical tests’’; and 


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1 (B) in paragraph (2)(B), by striking ‘‘ani2 mal’’ and inserting ‘‘nonclinical tests’’; and 

3 (2) after subsection (y), by inserting the fol4 lowing: 

5 ‘‘(z) NONCLINICAL TEST DEFINED.—For purposes 

6 of this section, the term ‘nonclinical test’ means a test con7 ducted in vitro, in silico, or in chemico, or a non-human 

8 in vivo test that occurs before or during the clinical trial 

9 phase of the investigation of the safety and effectiveness 

10 of a drug, and may include animal tests, or non-animal 

11 or human biology-based test methods, such as cell-based 

12 assays, microphysiological systems, or computer models.’’. 

13 (b) BIOSIMILAR BIOLOGICAL PRODUCT APPLICA14 TIONS.—Item (bb) of section 351(k)(2)(A)(i)(I) of the 

15 Public Health Service Act (42 U.S.C. 262(k)(2)(A)(i)(I)) 

16 is amended to read as follows: 

17 ‘‘(bb) an assessment of tox18 icity (which may rely on, or con19 sist of, a study or studies de20 scribed in item (aa) or (cc)); 

21 and’’. 

22 SEC. 502. SAFER DISPOSAL OF OPIOIDS. 

23 Section 505–1(e)(4)(B) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 355–1(e)(4)(B)) is amended 

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1 able (as defined in section 1300.05 of title 21, Code of 

2 Federal Regulations (or any successor regulation))’’. 

3 SEC. 503. CLARIFICATIONS TO EXCLUSIVITY PROVISIONS 

4 FOR FIRST INTERCHANGEABLE BIOSIMILAR 

5 BIOLOGICAL PRODUCTS. 

6 Section 351(k)(6) of the Public Health Service Act 

7 (42 U.S.C. 262(k)(6)) is amended— 

8 (1) in the matter preceding subparagraph (A)— 

9 (A) by striking ‘‘Upon review of’’ and in10 serting ‘‘The Secretary shall not make licensure 

11 as an interchangeable biological product effec12 tive with respect to’’; 

13 (B) by striking ‘‘relying on’’ and inserting 

14 ‘‘that relies on’’; and 

15 (C) by striking ‘‘the Secretary shall not 

16 make a determination under paragraph (4) that 

17 the second or subsequent biological product is 

18 interchangeable for any condition of use’’; and 

19 (2) in the flush text that follows subparagraph 

20 (C), by striking the period and inserting ‘‘, and the 

21 term ‘first interchangeable biosimilar biological prod22 uct’ means any interchangeable biosimilar biological 

23 product that is approved on the first day on which 

24 such a product is approved as interchangeable with 

25 the reference product.’’. 


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1 SEC. 504. IMPROVEMENTS TO THE PURPLE BOOK. 

2 (a) IN GENERAL.—Section 506I of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 

4 (1) in subsection (a)— 

5 (A) by striking ‘‘The holder of an applica6 tion approved under subsection (c) or (j) of sec7 tion 505’’ and inserting ‘‘The holder of an ap8 plication approved under subsection (c) or (j) of 

9 section 505 of this Act or subsection (a) or (k) 

10 of section 351 of the Public Health Service 

11 Act’’; 

12 (B) in paragraph (2), by inserting ‘‘(in the 

13 case of a biological product, the proper name)’’ 

14 after ‘‘established name’’; and 

15 (C) in paragraph (3), by striking ‘‘or ab16 breviated application number’’ and inserting ‘‘, 

17 abbreviated application number, or biologics li18 cense application number’’; and 

19 (2) in subsection (b)— 

20 (A) in the matter preceding paragraph (1), 

21 by striking ‘‘The holder of an application ap22 proved under subsection (c) or (j)’’ and insert23 ing ‘‘The holder of an application approved 

24 under subsection (c) or (j) of section 505 of 

25 this Act or subsection (a) or (k) of section 351 

26 of the Public Health Service Act’’; 


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1 (B) in paragraph (1), by inserting ‘‘(in the 

2 case of a biological product, the proper name)’’ 

3 after ‘‘established name’’; and 

4 (C) in paragraph (2), by striking ‘‘or ab5 breviated application number’’ and inserting ‘‘, 

6 abbreviated application number, or biologics li7 cense application number’’. 

8 (b) ADDITIONAL ONE-TIME REPORT.—Subsection 

9 (c) of section 506I of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 356i) is amended to read as follows: 

11 ‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 

12 days of the date of enactment of the Food and Drug Ad13 ministration Safety and Landmark Advancements Act of 

14 2022, all holders of applications approved under sub15 section (a) or (k) of section 351 of the Public Health Serv16 ice Act shall review the information in the list published 

17 under section 351(k)(9)(A) and shall submit a written no18 tice to the Secretary— 

19 ‘‘(1) stating that all of the application holder’s 

20 biological products in the list published under sec21 tion 351(k)(9)(A) that are not listed as discontinued 

22 are available for sale; or 

23 ‘‘(2) including the information required pursu24 ant to subsection (a) or (b), as applicable, for each 

25 of the application holder’s biological products that 


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1 are in the list published under section 351(k)(9)(A) 

2 and not listed as discontinued, but have been discon3 tinued from sale or never have been available for 

4 sale.’’. 

5 (c) PURPLE BOOK.—Section 506I of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amend7 ed— 

8 (1) in subsection (d)— 

9 (A) by striking ‘‘or (c), the Secretary’’ and 

10 inserting ‘‘or (c)— 

11 ‘‘(1) the Secretary’’; 

12 (B) by striking the period at the end, and 

13 inserting ‘‘; and’’; and 

14 (C) by adding at the end the following: 

15 ‘‘(2) the Secretary may identify the application 

16 holder’s biological products as discontinued in the 

17 list published under section 351(k)(9)(A) of the 

18 Public Health Service Act, except that the Secretary 

19 shall remove from the list in accordance with section 

20 351(k)(9)(B) of such Act any biological product for 

21 which a license has been revoked or suspended for 

22 reasons of safety, purity, or potency.’’; and 

23 (2) in subsection (e)— 

24 (A) by inserting after the first sentence the 

25 following: ‘‘The Secretary shall update the list 


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1 published under section 351(k)(9)(A) of the 

2 Public Health Service Act based on information 

3 provided under subsections (a), (b), and (c) by 

4 identifying as discontinued biological products 

5 that are not available for sale, except that any 

6 biological product for which the license has been 

7 revoked or suspended for reasons of safety, pu8 rity, or potency shall be removed from the list 

9 in accordance with section 351(k)(9)(B) of the 

10 Public Health Service Act.’’; and 

11 (B) in the last sentence— 

12 (i) by striking ‘‘updates to the list’’ 

13 and inserting ‘‘updates to the lists pub14 lished under section 505(j)(7)(A) of this 

15 Act and section 351(k)(9)(A) of the Public 

16 Health Service Act’’; and 

17 (ii) by striking ‘‘update the list’’ and 

18 inserting ‘‘update such lists’’. 

19 SEC. 505. THERAPEUTIC EQUIVALENCE EVALUATIONS. 

20 Section 505(j)(7)(A) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 355(j)(7)(A)) is amended by 

22 adding at the end the following: 

23 ‘‘(v)(I) With respect to an application submitted pur24 suant to subsection (b)(2) for a drug that is subject to 

25 section 503(b) for which the sole difference from a listed 


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1 drug relied upon in the application is a difference in inac2 tive ingredients not permitted under clause (iii) or (iv) of 

3 section 314.94(a)(9) of title 21, Code of Federal Regula4 tions (or successor regulations), the Secretary shall make 

5 an evaluation with respect to whether such drug is a thera6 peutic equivalent (as defined in section 314.3 of title 21, 

7 Code of Federal Regulations (or any successor regula8 tions)) to another approved drug product in the prescrip9 tion drug product section of the list under this paragraph 

10 as follows: 

11 ‘‘(aa) With respect to such an application sub12 mitted after the date of enactment of the Food and 

13 Drug Administration Safety and Landmark Ad14 vancements Act of 2022, the evaluation shall be 

15 made with respect to a listed drug relied upon in the 

16 application under subsection (b)(2) that is a phar17 maceutical equivalent (as defined in section 314.3 of 

18 title 21, Code of Federal Regulations (or any suc19 cessor regulations)) to the drug in the application 

20 under subsection (b)(2) at the time of approval of 

21 such application or not later than 180 days after the 

22 date of such approval, provided that the request for 

23 such a determination is made in the original applica24 tion (or in a resubmission to a complete response 

25 letter), and all necessary data and information are 


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1 submitted in the original application (or in a resub2 mission in response to a complete response letter) 

3 for the therapeutic equivalence evaluation, including 

4 information to demonstrate bioequivalence, in a form 

5 and manner prescribed by the Secretary. 

6 ‘‘(bb) With respect to such an application sub7 mitted prior to the date of enactment of the Food 

8 and Drug Administration Safety and Landmark Ad9 vancements Act of 2022, with respect to an applica10 tion approved on or after the date of enactment of 

11 such Act, the evaluation shall be made not later 

12 than 180 days after receipt of a request for a thera13 peutic equivalence evaluation submitted as part of a 

14 supplement to such application; or with respect to an 

15 application that was not approved as of the date of 

16 enactment of such Act, the evaluation shall be made 

17 not later than 180 days after the date of approval 

18 of such application if a request for such evaluation 

19 is submitted to the application, provided that— 

20 ‘‘(AA) such request for a therapeutic 

21 equivalent evaluation is being sought with re22 spect to a listed drug relied upon in the applica23 tion, and the relied upon listed drug is in the 

24 prescription drug product section of the list 

25 under this paragraph and is a pharmaceutical 


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1 equivalent (as defined in section 314.3 of title 

2 21, Code of Federal Regulations (or any suc3 cessor regulations)) to the drug for which a 

4 therapeutic equivalence evaluation is sought; 

5 and 

6 ‘‘(BB) the initial submission containing 

7 such request, or the relevant application, in8 cludes all necessary data and information for 

9 the therapeutic equivalence evaluation, includ10 ing information to demonstrate bioequivalence, 

11 in a form and manner prescribed by the Sec12 retary. 

13 ‘‘(II) When the Secretary makes an evaluation under 

14 subclause (I), the Secretary shall, in revisions made to the 

15 list pursuant to clause (ii), include such information for 

16 such drug.’’. 

17 SEC. 506. MODERNIZING ACCELERATED APPROVAL. 

18 (a) IN GENERAL.—Section 506(c) of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) is 

20 amended— 

21 (1) in paragraph (2)— 

22 (A) by redesignating subparagraphs (A) 

23 and (B) as clauses (i) and (ii), respectively, and 

24 adjusting the margins accordingly; 


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1 (B) by striking ‘‘Approval of a product’’ 

2 and inserting the following: 

3 ‘‘(A) IN GENERAL.—Approval of a prod4 uct’’; 

5 (C) in clause (i) of such subparagraph (A), 

6 as so redesignated, by striking ‘‘appropriate 

7 postapproval studies’’ and inserting ‘‘an appro8 priate postapproval study or studies (which may 

9 be augmented or supported by real world evi10 dence)’’; and 

11 (D) by adding at the end the following: 

12 ‘‘(B) STUDIES NOT REQUIRED.—If the 

13 Secretary does not require that the sponsor of 

14 a product approved under accelerated approval 

15 conduct a postapproval study under this para16 graph, the Secretary shall publish on the 

17 website of the Food and Drug Administration 

18 the rationale for why such study is not appro19 priate or necessary. 

20 ‘‘(C) POSTAPPROVAL STUDY CONDI21 TIONS.—Not later than the time of approval of 

22 a product under accelerated approval, the Sec23 retary shall specify the conditions for a post24 approval study or studies required to be con25 ducted under this paragraph with respect to 


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1 such product, which may include enrollment 

2 targets, the study protocol, and milestones, in3 cluding the target date of study completion. 

4 ‘‘(D) STUDIES BEGUN BEFORE AP5 PROVAL.—The Secretary may require such 

6 study or studies to be underway prior to ap7 proval.’’; and 

8 (2) in paragraph (3)— 

9 (A) by redesignating subparagraphs (A) 

10 through (D) as clauses (i) through (iv), respec11 tively and adjusting the margins accordingly; 

12 (B) by striking ‘‘The Secretary may’’ and 

13 inserting the following: 

14 ‘‘(A) IN GENERAL.—The Secretary may’’; 

15 (C) in clause (i) of such subparagraph (A), 

16 as so redesignated, by striking ‘‘drug with due 

17 diligence’’ and inserting ‘‘product with due dili18 gence, including with respect to conditions spec19 ified by the Secretary under paragraph (2)(C)’’; 

20 (D) in clause (iii) of such subparagraph 

21 (A), as so redesignated, by inserting ‘‘shown to 

22 be’’ after ‘‘product is not’’; and 

23 (E) by adding at the end the following: 

24 ‘‘(B) EXPEDITED PROCEDURES DE25 SCRIBED.—Expedited procedures described in 


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1 this subparagraph shall consist of, prior to the 

2 withdrawal of accelerated approval— 

3 ‘‘(i) providing the sponsor with— 

4 ‘‘(I) due notice; 

5 ‘‘(II) an explanation for the pro6 posed withdrawal; 

7 ‘‘(III) an opportunity for a meet8 ing with the Commissioner or the 

9 Commissioner’s designee; and 

10 ‘‘(IV) an opportunity for written 

11 appeal to— 

12 ‘‘(aa) the Commissioner; or 

13 ‘‘(bb) a designee of the 

14 Commissioner who has not par15 ticipated in the proposal with16 drawal of approval (other than a 

17 meeting pursuant to subclause 

18 (III)) and is not subordinate of 

19 an individual (other than the 

20 Commissioner) who participated 

21 in such proposed withdrawal; 

22 ‘‘(ii) providing an opportunity for 

23 public comment on the proposing to with24 drawal approval; 


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1 ‘‘(iii) the publication of a summary of 

2 the public comments received, and the Sec3 retary’s response to such comments, on the 

4 website of the Food and Drug Administra5 tion; and 

6 ‘‘(iv) convening and consulting an ad7 visory committee on issues related to the 

8 proposed withdrawal, if requested by the 

9 sponsor and if no such advisory committee 

10 has previously advised the Secretary on 

11 such issues with respect to the withdrawal 

12 of the product prior to the sponsor’s re13 quest.’’. 

14 (b) REPORTS OF POSTMARKETING STUDIES.—Sec15 tion 506B of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 356b(a)) is amended— 

17 (1) by redesignating paragraph (2) as para18 graph (3); and 

19 (2) by inserting after paragraph (1) the fol20 lowing: 

21 ‘‘(2) ACCELERATED APPROVAL.—Notwith22 standing paragraph (1), a sponsor of a drug ap23 proved under accelerated approval shall submit to 

24 the Secretary a report of the progress of any study 

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1 ward enrollment targets, milestones, and other infor2 mation as required by the Secretary, not later than 

3 180 days after the approval of such drug and not 

4 less frequently than every 180 days thereafter, until 

5 the study is completed or terminated.’’. 

6 (c) ENFORCEMENT.—Section 301 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 

8 amended by section 824, is further amended by adding 

9 at the end the following: 

10 ‘‘(ll) The failure of a sponsor of a product approved 

11 under accelerated approval pursuant to section 506(c)— 

12 ‘‘(1) to conduct with due diligence any post13 approval study required under section 506(c) with 

14 respect to such product; or 

15 ‘‘(2) to submit timely reports with respect to 

16 such product in accordance with section 

17 506B(a)(2).’’. 

18 (d) GUIDANCE.— 

19 (1) IN GENERAL.—The Secretary of Health and 

20 Human Services shall issue guidance describing— 

21 (A) how sponsor questions related to the 

22 identification of novel surrogate or intermediate 

23 clinical endpoints may be addressed in early24 stage development meetings with the Food and 

25 Drug Administration; 


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1 (B) the use of novel clinical trial designs 

2 that may be used to conduct appropriate post3 approval studies as may be required under sec4 tion 506(c)(2)(A) of the Federal Food, Drug, 

5 and Cosmetic Act, as amended by subsection 

6 (a); 

7 (C) the expedited procedures described in 

8 section 506(c)(3)(B) of the Federal Food, 

9 Drug, and Cosmetic Act; and 

10 (D) considerations related to the use of 

11 surrogate or intermediate clinical endpoints 

12 that may support the accelerated approval of an 

13 application under 506(c)(1)(A), including con14 siderations in evaluating the evidence related to 

15 any such endpoints. 

16 (2) FINAL GUIDANCE.—The Secretary shall 

17 issue— 

18 (A) a draft guidance under paragraph (1) 

19 not later than 18 months after the date of en20 actment of this Act; and 

21 (B) final guidance not later than 1 year 

22 after the close of the public comment period on 

23 such draft guidance. 

24 (e) RARE DISEASE ENDPOINT ADVANCEMENT

25 PILOT.— 


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1 (1) IN GENERAL.—The Secretary of Health and 

2 Human Services shall establish a pilot program 

3 under which the Secretary will establish procedures 

4 to provide increased interaction with sponsors of 

5 rare disease drug development programs for pur6 poses of advancing the development of efficacy 

7 endpoints, including surrogate and intermediate 

8 endpoints, for drugs intended to treat rare diseases, 

9 including through— 

10 (A) determining eligibility of participants 

11 for such program; and 

12 (B) developing and implementing a process 

13 for applying to, and participating in, such a 

14 program. 

15 (2) PUBLIC WORKSHOPS.—The Secretary shall 

16 conduct up to 3 public workshops, which shall be 

17 completed not later than September 30, 2026, to 

18 discuss topics relevant to the development of 

19 endpoints for rare diseases, which may include dis20 cussions about— 

21 (A) novel endpoints developed through the 

22 pilot program established under this subsection; 

23 and 

24 (B) as appropriate, the use of real world 

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1 dation of efficacy endpoints, including surrogate 

2 and intermediate endpoints, for rare diseases. 

3 (3) REPORT.—Not later than September 30, 

4 2027, the Secretary shall submit to the Committee 

5 on Energy and Commerce of the House of Rep6 resentatives and the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate a report 

8 describing the outcomes of the pilot program estab9 lished under this subsection. 

10 (4) GUIDANCE.—Not later than September 30, 

11 2027, the Secretary shall issue guidance describing 

12 best practices and strategies for development of effi13 cacy endpoints, including surrogate and intermediate 

14 endpoints, for rare diseases. 

15 (5) SUNSET.—The Secretary may not accept 

16 any new application or request to participate in the 

17 program established by this subsection on or after 

18 October 1, 2027. 

19 (f) ACCELERATED APPROVAL COUNCIL.— 

20 (1) GENERAL.—Not later than 180 days after 

21 the date of enactment of this Act, the Secretary of 

22 Health and Human Services shall establish an intra23 agency coordinating council within the Food and 

24 Drug Administration to ensure the consistent and 

25 appropriate use of accelerated approval across the 


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1 Food and Drug Administration, pursuant to section 

2 506(c) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 356(c)). 

4 (2) MEMBERSHIP.—The members of the Coun5 cil shall consist of the following senior officials, or 

6 a designee of such official, from the Food and Drug 

7 Administration and relevant Centers: 

8 (A) The Director of the Center for Drug 

9 Evaluation and Research. 

10 (B) The Director of the Center for Bio11 logics Evaluation and Research. 

12 (C) The Director of the Oncology Center 

13 of Excellence. 

14 (D) The Director of the Office of New 

15 Drugs. 

16 (E) The Director of the Office of Orphan 

17 Products Development. 

18 (F) The Director of the Office of Tissues 

19 and Advanced Therapies. 

20 (G) The Director of the Office of Medical 

21 Policy. 

22 (H) At least 3 directors of review division 

23 overseeing products approved under accelerated 

24 approval, including at least one director of a re25 view division within the Office of Neuroscience. 


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1 (3) DUTIES OF THE COUNCIL.— 

2 (A) MEETINGS.—The Council shall con3 vene not fewer than 3 times per calendar year 

4 to discuss issues related to accelerated approval, 

5 including any relevant cross-disciplinary ap6 proaches related to product review with respect 

7 to accelerated approval. 

8 (B) POLICY DEVELOPMENT.—The Council 

9 shall directly engage with product review teams 

10 to support the consistent and appropriate use of 

11 accelerated approval across the Food and Drug 

12 Administration. Such activities may include— 

13 (i) developing guidance for Food and 

14 Drug Administration staff and best prac15 tices for, and across, product review teams, 

16 including with respect to communication 

17 between sponsors and the Food and Drug 

18 Administration and the review of products 

19 under accelerated approval; 

20 (ii) providing training for product re21 view teams; and 

22 (iii) advising review divisions on prod23 uct-specific development, review, and with24 drawal of products under accelerated ap25 proval. 


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1 (4) PUBLICATION OF A REPORT.—Not later 

2 than 1 year after the date of enactment of this Act, 

3 and annually thereafter, the council shall publish on 

4 the public website of the Food and Drug Adminis5 tration a report on the activities of the council. 

6 (g) RULE OF CONSTRUCTION.—Nothing in this sec7 tion (including the amendments made by this section) 

8 shall be construed to affect products approved under 

9 506(c) of the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 356(c)) prior to the date of enactment of this Act. 

11 TITLE VI—OTHER 

12 REAUTHORIZATIONS 

13 SEC. 601. REAUTHORIZATION OF THE CRITICAL PATH PUB14 LIC-PRIVATE PARTNERSHIP. 

15 Section 566(f) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 

17 ‘‘2018 through 2022’’ and inserting ‘‘2023 through 

18 2027’’. 

19 SEC. 602. REAUTHORIZATION OF THE BEST PHARMA20 CEUTICALS FOR CHILDREN PROGRAM. 

21 Section 409I(d)(1) of the Public Health Service Act 

22 (42 U.S.C. 284m(d)(1)) is amended by striking ‘‘2018 

23 through 2022’’ and inserting ‘‘2023 through 2027’’. 


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1 SEC. 603. REAUTHORIZATION OF THE HUMANITARIAN DE2 VICE EXEMPTION INCENTIVE. 

3 Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 

4 and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 

5 amended by striking ‘‘2022’’ and inserting ‘‘2027’’. 

6 SEC. 604. REAUTHORIZATION OF THE PEDIATRIC DEVICE 

7 CONSORTIA PROGRAM. 

8 Section 305(e) of the Food and Drug Administration 

9 Amendments Act of 2007 (Public Law 110–85; 42 U.S.C. 

10 282 note) is amended by striking ‘‘$5,250,000 for each 

11 of fiscal years 2018 through 2022’’ and inserting 

12 ‘‘$7,000,000 for each of fiscal years 2023 through 2027’’. 

13 SEC. 605. REAUTHORIZATION OF PROVISION PERTAINING 

14 TO DRUGS CONTAINING SINGLE 

15 ENANTIOMERS. 

16 Section 505(u) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355(u)) is amended by— 

18 (1) in paragraph (1)(A)(ii)(II), by adding 

19 ‘‘(other than bioavailability studies)’’ after ‘‘any clin20 ical investigations’’; and 

21 (2) in paragraph (4), by striking ‘‘October 1, 

22 2022’’ and inserting ‘‘October 1, 2027’’. 

23 SEC. 606. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 

24 Section 5(c) of the Orphan Drug Act (21 U.S.C. 

25 360ee(c)) is amended by striking ‘‘2018 through 2022’’ 

26 and inserting ‘‘2023 through 2027’’. 


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1 SEC. 607. REAUTHORIZATION OF CERTAIN DEVICE INSPEC2 TIONS. 

3 Section 704(g)(11) of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by strik5 ing ‘‘2022’’ and inserting ‘‘2027’’. 

6 TITLE VII—ENHANCING FDA 

7 HIRING AUTHORITIES 

8 SEC. 701. ENHANCING FDA HIRING AUTHORITY FOR SCI9 ENTIFIC, TECHNICAL, AND PROFESSIONAL 

10 PERSONNEL. 

11 Section 714A of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 379d–3a) is amended— 

13 (1) in subsection (a)— 

14 (A) by inserting ‘‘, including cross-cutting 

15 operational positions,’’ after ‘‘professional posi16 tions’’; and 

17 (B) by inserting ‘‘and the regulation of 

18 food’’ after ‘‘medical products’’; and 

19 (2) in subsection (d)(1)— 

20 (A) in the matter preceding subparagraph 

21 (A)— 

22 (i) by striking ‘‘the 21st Century 

23 Cures Act’’ and inserting ‘‘the Food and 

24 Drug Administration Safety and Land25 mark Advancements Act of 2022’’; and 


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1 (ii) by striking ‘‘that examines the ex2 tent’’ and all that follows through ‘‘, in3 cluding’’ and inserting ‘‘that addresses’’; 

4 (B) in subparagraph (A)— 

5 (i) by inserting ‘‘updated’’ before 

6 ‘‘analysis’’; and 

7 (ii) by striking ‘‘; and’’ and inserting 

8 a semicolon; 

9 (C) by redesignating subparagraph (B) as 

10 subparagraph (C); 

11 (D) by inserting after subparagraph (A) 

12 the following: 

13 ‘‘(B) an analysis of how the Secretary has 

14 used the authorities provided under this section, 

15 and a plan for how the Secretary will use the 

16 authority under this section, and other applica17 ble hiring authorities, for employees of the 

18 Food and Drug Administration; and’’; and 

19 (E) in subparagraph (C), as so redesig20 nated, by striking ‘‘a recruitment’’ and insert21 ing ‘‘an updated recruitment’’. 

22 SEC. 702. STRATEGIC WORKFORCE PLAN AND REPORT. 

23 Chapter VII of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 371 et seq.) is amended by inserting 

25 after section 714A the following: 


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1 ‘‘SEC. 714B. STRATEGIC WORKFORCE PLAN AND REPORT. 

2 ‘‘(a) IN GENERAL.—Not later than September 30, 

3 2023, and at least every 4 years thereafter, the Secretary 

4 shall develop and submit to the appropriate committees 

5 of Congress and post on the website of the Food and Drug 

6 Administration, a coordinated strategy and report to pro7 vide direction for the activities and programs of the Sec8 retary to recruit, hire, train, develop, and retain the work9 force needed to fulfill the public health mission of the 

10 Food and Drug Administration, including to facilitate col11 laboration across centers, to keep pace with new bio12 medical, technological, and scientific advancements, and 

13 support the development, review, and regulation of med14 ical products. Each such report shall be known as the 

15 ‘Food and Drug Administration Strategic Workforce 

16 Plan’. 

17 ‘‘(b) USE OF THE FOOD AND DRUG ADMINISTRATION

18 STRATEGIC WORKFORCE PLAN.—Each center within the 

19 Food and Drug Administration shall develop and update, 

20 as appropriate, a strategic plan that will be informed by 

21 the Food and Drug Administration Strategic Workforce 

22 Plan developed and updated under this subsection. 

23 ‘‘(c) CONTENTS OF THE FOOD AND DRUG ADMINIS24 TRATION STRATEGIC WORKFORCE PLAN.—Each Food 

25 and Drug Administration Strategic Workforce Plan under 

26 subsection (a) shall— 


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1 ‘‘(1) include agency-wide strategic goals and 

2 priorities for recruiting, hiring, training, developing, 

3 and retaining a qualified workforce for the Food and 

4 Drug Administration; 

5 ‘‘(2) establish specific activities the Secretary 

6 will take to achieve its strategic goals and priorities 

7 and address the workforce needs of the Food and 

8 Drug Administration in the forthcoming fiscal years; 

9 ‘‘(3) identify challenges and risks the Secretary 

10 will face in meeting its strategic goals and priorities, 

11 and the activities the Secretary will undertake to 

12 overcome those challenges and mitigate those risks; 

13 ‘‘(4) establish metrics and milestones that the 

14 Secretary will use to measure progress in achieving 

15 its strategic goals and priorities; and 

16 ‘‘(5) define functions, capabilities, and gaps in 

17 such workforce and identify strategies to recruit, 

18 hire, train, develop, and retain such workforce. 

19 ‘‘(d) CONSIDERATIONS.—In developing each Food 

20 and Drug Administration Strategic Workforce Plan under 

21 subsection (a), the Secretary shall consider— 

22 ‘‘(1) the number of employees, employee exper23 tise, and employing center of employees, including 

24 senior leadership and non-senior leadership employ25 ees, eligible for retirement; 


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1 ‘‘(2) the vacancy and turnover rates for employ2 ees with different types of expertise and from dif3 ferent centers, including any changes or trends re4 lated to such rates; 

5 ‘‘(3) the results of the Federal Employee View6 point Survey for employees of the Food and Drug 

7 Administration, including any changes or trends re8 lated to such results; 

9 ‘‘(4) rates of pay for different types of posi10 tions, including rates for different types of expertise 

11 within the same field (such as differences in pay be12 tween different medical specialists), and how such 

13 rates of pay impact the ability of the Secretary to 

14 achieve strategic goals and priorities; and 

15 ‘‘(5) the statutory hiring authorities used to 

16 hire Food and Drug Administration employees, and 

17 the time to hire across different hiring authorities. 

18 ‘‘(e) EVALUATION OF PROGRESS.—Each Food and 

19 Drug Administration Strategic Workforce Plan issued 

20 pursuant to subsection (a), with the exception of the first 

21 such Food and Drug Administration Strategic Workforce 

22 Plan, shall include an evaluation of the progress the Sec23 retary has made, based on the metrics, benchmarks, and 

24 other milestones that measure successful recruitment, hir25 ing, training, development, and retention activities; and 


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1 whether such actions improved the capacity of the Food 

2 and Drug Administration to achieve the strategic goals 

3 and priorities set forth in the previous Food and Drug 

4 Administration Strategic Workforce Plan. 

5 ‘‘(f) ADDITIONAL CONSIDERATIONS.—The Food and 

6 Drug Administration Strategic Workforce Plan issued in 

7 fiscal year 2023 shall address the effect of the COVID– 

8 19 pandemic on hiring, retention, and other workforce 

9 challenges for the Food and Drug Administration, includ10 ing protecting such workforce during public health emer11 gencies.’’. 

12 TITLE VIII—ADVANCING REGU13 LATION OF COSMETICS, DIE14 TARY SUPPLEMENTS, AND 

15 LABORATORY DEVELOPED 

16 TESTS 

17 Subtitle A—Cosmetics 

18 SEC. 801. SHORT TITLE. 

19 This subtitle may be cited as the ‘‘Modernization of 

20 Cosmetics Regulation Act of 2022’’. 

21 SEC. 802. AMENDMENTS TO COSMETIC REQUIREMENTS. 

22 Chapter VI of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 361 et seq.) is amended by adding at the 

24 end the following: 


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1 ‘‘SEC. 604. DEFINITIONS. 

2 ‘‘In this chapter: 

3 ‘‘(1) ADVERSE EVENT.—The term ‘adverse 

4 event’ means any health-related event associated 

5 with the use of a cosmetic product that is adverse. 

6 ‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 

7 product’ means a preparation of cosmetic ingredi8 ents with a qualitatively and quantitatively set com9 position for use in a finished product. 

10 ‘‘(3) FACILITY.— 

11 ‘‘(A) IN GENERAL.—The term ‘facility’ in12 cludes any establishment (including an estab13 lishment of an importer) that manufactures or 

14 processes cosmetic products distributed in the 

15 United States. 

16 ‘‘(B) Such term does not include any of 

17 the following: 

18 ‘‘(i) Beauty shops and salons, unless 

19 such establishment manufactures or proc20 esses cosmetic products at that location. 

21 ‘‘(ii) Cosmetic product retailers, in22 cluding individual sales representatives, di23 rect sellers, retail distribution facilities, 

24 and pharmacies, unless such establishment 

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1 ucts that are not sold directly to con2 sumers at that location. 

3 ‘‘(iii) Hospitals, physicians’ offices, 

4 and health care clinics. 

5 ‘‘(iv) Public health agencies and other 

6 nonprofit entities that provide cosmetic 

7 products directly to the consumer. 

8 ‘‘(v) Entities (such as hotels and air9 lines) that provide complimentary cosmetic 

10 products to customers incidental to other 

11 services. 

12 ‘‘(vi) Trade shows and other venues 

13 where cosmetic product samples are pro14 vided free of charge. 

15 ‘‘(vii) An establishment that manufac16 tures or processes cosmetic products that 

17 are solely for use in research or evaluation, 

18 including for production testing and not of19 fered for retail sale. 

20 ‘‘(viii) An establishment that solely 

21 performs one or more of the following with 

22 respect to cosmetic products: 

23 ‘‘(I) Labeling. 

24 ‘‘(II) Relabeling. 

25 ‘‘(III) Packaging. 


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1 ‘‘(IV) Repackaging. 

2 ‘‘(V) Holding. 

3 ‘‘(VI) Distributing. 

4 ‘‘(C) CLARIFICATION.—For the purposes 

5 of subparagraph (B)(viii), the terms ‘packaging’ 

6 and ‘repackaging’ do not include filling a prod7 uct container with a cosmetic product. 

8 ‘‘(4) RESPONSIBLE PERSON.—The term ‘re9 sponsible person’ means the manufacturer, packer, 

10 or distributor of a cosmetic product whose name ap11 pears on the label of such cosmetic product in ac12 cordance with section 609(a) of this Act or section 

13 4(a) of the Fair Packaging and Labeling Act. 

14 ‘‘(5) SERIOUS ADVERSE EVENT.—The term ‘se15 rious adverse event’ means an adverse event that— 

16 ‘‘(A) results in— 

17 ‘‘(i) death; 

18 ‘‘(ii) a life-threatening experience; 

19 ‘‘(iii) inpatient hospitalization; 

20 ‘‘(iv) a persistent or significant dis21 ability or incapacity; 

22 ‘‘(v) a congenital anomaly or birth de23 fect; or 

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1 tions, second- or third-degree burns, sig2 nificant hair loss, or permanent or signifi3 cant alteration of appearance), other than 

4 as intended, under conditions of use that 

5 are customary or usual; or 

6 ‘‘(B) requires, based on reasonable medical 

7 judgment, a medical or surgical intervention to 

8 prevent an outcome described in subparagraph 

9 (A). 

10 ‘‘SEC. 605. ADVERSE EVENTS. 

11 ‘‘(a) SERIOUS ADVERSE EVENT REPORTING RE12 QUIREMENTS.—The responsible person shall submit to the 

13 Secretary any report received of a serious adverse event 

14 associated with the use, in the United States, of a cosmetic 

15 product manufactured, packed, or distributed by such per16 son. 

17 ‘‘(b) SUBMISSION OF REPORTS.— 

18 ‘‘(1) SERIOUS ADVERSE EVENT REPORT.—The 

19 responsible person shall submit to the Secretary a 

20 serious adverse event report accompanied by a copy 

21 of the label on or within the retail packaging of such 

22 cosmetic product no later than 15 business days 

23 after the report is received by the responsible per24 son. 


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1 ‘‘(2) NEW MEDICAL INFORMATION.—The re2 sponsible person shall submit to the Secretary any 

3 new and material medical information, related to a 

4 serious adverse event report submitted to the Sec5 retary in accordance with paragraph (1), that is re6 ceived by the responsible person within 1 year of the 

7 initial report to the Secretary, no later than 15 busi8 ness days after such information is received by such 

9 responsible person. 

10 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec11 retary shall develop systems to enable responsible 

12 persons to submit a single report that includes du13 plicate reports of, or new medical information re14 lated to, a serious adverse event. 

15 ‘‘(c) EXEMPTIONS.—The Secretary may establish by 

16 regulation an exemption to any of the requirements of this 

17 section if the Secretary determines that such exemption 

18 would have no significant adverse effect on public health. 

19 ‘‘(d) CONTACT INFORMATION.—The responsible per20 son shall receive reports of adverse events through the do21 mestic address, domestic telephone number, or electronic 

22 contact information included on the label in accordance 

23 with section 609(a). 

24 ‘‘(e) MAINTENANCE AND INSPECTION OF ADVERSE

25 EVENT RECORDS.— 


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1 ‘‘(1) MAINTENANCE.—The responsible person 

2 shall maintain records related to each report of an 

3 adverse event associated with the use, in the United 

4 States, of a cosmetic product manufactured or dis5 tributed by such person received by such person, for 

6 a period of 6 years. 

7 ‘‘(2) INSPECTION.— 

8 ‘‘(A) IN GENERAL.— The responsible per9 son shall permit an authorized person to have 

10 access to records required to be maintained 

11 under this section during an inspection pursu12 ant to section 704. 

13 ‘‘(B) AUTHORIZED PERSON.—For pur14 poses of this paragraph, the term ‘authorized 

15 person’ means an officer or employee of the De16 partment of Health and Human Services who 

17 has— 

18 ‘‘(i) appropriate credentials, as deter19 mined by the Secretary; and 

20 ‘‘(ii) been duly designated by the Sec21 retary to have access to the records re22 quired under this section. 

23 ‘‘(f) FRAGRANCE AND FLAVOR INGREDIENTS.—If 

24 the Secretary has reasonable grounds to believe that an 

25 ingredient or combination of ingredients in a fragrance or 


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1 flavor has caused or contributed to a serious adverse event 

2 required to be reported under this section, the Secretary 

3 may request in writing a complete list of ingredients in 

4 the specific fragrances or flavors in the cosmetic product, 

5 from the responsible person. The responsible person shall 

6 ensure that the requested information is submitted to the 

7 Secretary within 30 days of such request. Information 

8 submitted to the Secretary under this subsection that is 

9 confidential commercial or trade secret information shall 

10 be exempt from disclosure under section 552 of title 5, 

11 United States Code. 

12 ‘‘(g) PROTECTED INFORMATION.—A serious adverse 

13 event report submitted to the Secretary under this section, 

14 including any new medical information submitted under 

15 subsection (a)(2), or an adverse event report, or any new 

16 information, voluntarily submitted to the Secretary shall 

17 be considered to be— 

18 ‘‘(1) a safety report under section 756 and may 

19 be accompanied by a statement, which shall be a 

20 part of any report that is released for public disclo21 sure, that denies that the report or the records con22 stitute an admission that the product involved 

23 caused or contributed to the adverse event; and 

24 ‘‘(2) a record about an individual under section 

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1 ferred to as the ‘Privacy Act of 1974’) and a med2 ical or similar file the disclosure of which would con3 stitute a violation of section 552 of such title 5 

4 (commonly referred to as the ‘Freedom of Informa5 tion Act’), and shall not be publicly disclosed unless 

6 all personally identifiable information is redacted. 

7 ‘‘(h) EFFECT OF SECTION.— 

8 ‘‘(1) IN GENERAL.—Nothing in this section 

9 shall affect the authority of the Secretary to provide 

10 adverse event reports and information to any health, 

11 food, or drug officer or employee of any State, terri12 tory, or political subdivision of a State or territory, 

13 under a memorandum of understanding between the 

14 Secretary and such State, territory, or political sub15 division. 

16 ‘‘(2) PERSONALLY IDENTIFIABLE INFORMA17 TION.—Notwithstanding any other provision of law, 

18 personally identifiable information in adverse event 

19 reports provided by the Secretary to any health, 

20 food, or drug officer or employee of any State, terri21 tory, or political subdivision of a State or territory, 

22 shall not— 

23 ‘‘(A) be made publicly available pursuant 

24 to any State or other law requiring disclosure 

25 of information or records; or 


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1 ‘‘(B) otherwise be disclosed or distributed 

2 to any party without the written consent of the 

3 Secretary and the person submitting such infor4 mation to the Secretary. 

5 ‘‘(3) USE OF REPORTS.—Nothing in this sec6 tion shall permit a State, territory, or political sub7 division of a State or territory, to use any safety re8 port received from the Secretary in a manner incon9 sistent with this section. 

10 ‘‘(4) RULE OF CONSTRUCTION.—The submis11 sion of any report in compliance with this section 

12 shall not be construed as an admission that the cos13 metic product involved caused or contributed to the 

14 relevant adverse event. 

15 ‘‘SEC. 606. GOOD MANUFACTURING PRACTICE. 

16 ‘‘(a) IN GENERAL.—The Secretary shall by regula17 tion establish good manufacturing practices for facilities 

18 that are consistent, to the extent practicable, and appro19 priate, with national and international standards, in ac20 cordance with section 601. Any such regulations shall be 

21 intended to protect the public health and ensure that cos22 metic products are not adulterated. Such regulations may 

23 allow for the Secretary to inspect records necessary to 

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1 tices prescribed by the Secretary under this paragraph 

2 during an inspection conducted under section 704. 

3 ‘‘(b) CONSIDERATIONS.—In establishing regulations 

4 for good manufacturing practices under this section, the 

5 Secretary shall take into account the size and scope of the 

6 businesses engaged in the manufacture of cosmetics, and 

7 the risks to public health posed by such cosmetics, and 

8 provide sufficient flexibility to be practicable for all sizes 

9 and types of facilities to which such regulations will apply. 

10 Such regulations shall include simplified good manufac11 turing practice requirements for smaller businesses, as ap12 propriate, to ensure that such regulations do not impose 

13 undue economic hardship for smaller businesses, and may 

14 include longer compliance times for smaller businesses. 

15 Before issuing regulations to implement subsection (a), 

16 the Secretary shall consult with cosmetics manufacturers, 

17 including smaller businesses, consumer organizations, and 

18 other experts selected by the Secretary. 

19 ‘‘(c) TIMEFRAME.—The Secretary shall publish a no20 tice of proposed rulemaking not later than 2 years after 

21 the date of enactment of the Modernization of Cosmetics 

22 Regulation Act of 2022 and shall publish a final such rule 

23 not later than 3 years after such date of enactment. 

24 ‘‘SEC. 607. REGISTRATION AND PRODUCT LISTING. 

25 ‘‘(a) SUBMISSION OF REGISTRATION.— 


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1 ‘‘(1) INITIAL REGISTRATION.— 

2 ‘‘(A) EXISTING FACILITIES.—Every person 

3 that, on the date of enactment of the Mod4 ernization of Cosmetics Regulation Act of 2022, 

5 owns or operates a facility that engages in the 

6 manufacturing or processing of a cosmetic 

7 product for distribution in the United States 

8 shall register each facility with the Secretary 

9 not later than 1 year after date of enactment 

10 of such Act. 

11 ‘‘(B) NEW FACILITIES.—Every person that 

12 owns or operates a facility that first engages, 

13 after the date of enactment of the Moderniza14 tion of Cosmetics Regulation Act of 2022, in 

15 manufacturing or processing of a cosmetic 

16 product for distribution in the United States, 

17 shall register with the Secretary such facility 

18 within 60 days of first engaging in such activity 

19 or 60 days after the deadline for registration 

20 under subparagraph (A), whichever is later. 

21 ‘‘(2) BIENNIAL RENEWAL OF REGISTRATION.— 

22 A person required to register a facility under para23 graph (1) shall renew such registrations with the 

24 Secretary biennially. 


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1 ‘‘(3) CONTRACT MANUFACTURERS.—If a facility 

2 manufactures or processes cosmetic products on be3 half of a responsible person, the Secretary shall re4 quire only a single registration for such facility even 

5 if such facility is manufacturing or processing its 

6 own cosmetic products or cosmetic products on be7 half of more than one responsible person. Such sin8 gle registration may be submitted to the Secretary 

9 by such facility or any responsible person whose 

10 products are manufactured or processed at such fa11 cility. 

12 ‘‘(4) UPDATES TO CONTENT.—A person that is 

13 required to register under subsection (a)(1) shall no14 tify the Secretary within 60 days of any changes to 

15 information required under subsection (b)(2). 

16 ‘‘(5) ABBREVIATED RENEWAL REGISTRA17 TIONS.—The Secretary shall provide for an abbre18 viated registration renewal process for any person 

19 that owns or operates a facility that has not been re20 quired to submit updates under paragraph (4) for a 

21 registered facility since submission of the most re22 cent registration of such facility under paragraph 

23 (1) or (2). 

24 ‘‘(b) FORMAT; CONTENTS OF REGISTRATION.— 


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1 ‘‘(1) IN GENERAL.—Registration information 

2 under this section may be submitted at such time 

3 and in such manner as the Secretary may prescribe. 

4 ‘‘(2) CONTENTS.—The registration under sub5 section (a) shall contain— 

6 ‘‘(A) the facility’s name, physical address, 

7 email address, and telephone number; 

8 ‘‘(B) with respect to any foreign facility, 

9 the contact for the United States agent of the 

10 facility, and, if available, the electronic contact 

11 information; 

12 ‘‘(C) the facility registration number, if 

13 any, previously assigned by the Secretary under 

14 subsection (d); 

15 ‘‘(D) all brand names under which cos16 metic products manufactured or processed in 

17 the facility are sold; and 

18 ‘‘(E) the product category or categories 

19 and responsible person for each cosmetic prod20 uct manufactured or processed at the facility. 

21 ‘‘(c) COSMETIC PRODUCT LISTING.— 

22 ‘‘(1) IN GENERAL.—For each cosmetic product, 

23 the responsible person shall submit, or ensure is sub24 mitted, to the Secretary a cosmetic product listing, 


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1 at such time and in such manner as the Secretary 

2 may prescribe. 

3 ‘‘(2) COSMETIC PRODUCT LISTING.—The re4 sponsible person of a cosmetic product that is mar5 keted on the date of enactment of the Modernization 

6 of Cosmetics Regulation Act of 2022 shall submit to 

7 the Secretary a cosmetic product listing not later 

8 than 1 year after the date of enactment of the Mod9 ernization of Cosmetics Regulation Act of 2022, or 

10 for a cosmetic product that is first marketed after 

11 the date of enactment of such Act, within 120 days 

12 of marketing such product in interstate commerce. 

13 Thereafter, any updates to such listing shall be 

14 made annually, consistent with paragraphs (4) and 

15 (5). 

16 ‘‘(3) ABBREVIATED RENEWAL.—The Secretary 

17 shall provide for an abbreviated process for the re18 newal of any cosmetic product listing under this sub19 section with respect to which there has been no 

20 change since the responsible person submitted the 

21 previous listing. 

22 ‘‘(4) CONTENTS OF LISTING.— 

23 ‘‘(A) IN GENERAL.—Each such cosmetic 

24 product listing shall include— 


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1 ‘‘(i) the facility registration number of 

2 each facility where the cosmetic product is 

3 manufactured or processed; 

4 ‘‘(ii) the name and contact number of 

5 the responsible person and the name for 

6 the cosmetic product, as such name ap7 pears on the label; 

8 ‘‘(iii) the applicable cosmetic category 

9 or categories for the cosmetic product; 

10 ‘‘(iv) a list of ingredients in the cos11 metic product, including any fragrances, 

12 flavors, or colors, with each ingredient 

13 identified by the name adopted in regula14 tions promulgated by the Secretary, if any, 

15 or by the common or usual name of the in16 gredient; and 

17 ‘‘(v) the product listing number, if 

18 any previously assigned by the Secretary 

19 under subsection (d). 

20 ‘‘(B) FLEXIBLE LISTINGS.—A single list21 ing submission for a cosmetic product may in22 clude multiple cosmetic products with identical 

23 formulations, or formulations that differ only 

24 with respect to colors, fragrances or flavors, or 

25 quantity of contents. 


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1 ‘‘(5) UPDATES TO CONTENT.—A responsible 

2 person that is required to submit a cosmetic product 

3 listing shall submit any updates to such cosmetic 

4 product listing annually. 

5 ‘‘(6) SUBMISSION.—A responsible person may 

6 submit product listing information as part of a facil7 ity registration or separately. 

8 ‘‘(d) FACILITY REGISTRATION AND PRODUCT LIST9 ING NUMBERS.—At the time of the initial registration of 

10 any facility under subsection (a)(1) or initial listing of any 

11 cosmetic product under (c)(1), the Secretary shall assign 

12 a facility registration number to the facility and a product 

13 listing number to each cosmetic product. The Secretary 

14 shall not make such product listing number publicly avail15 able. 

16 ‘‘(e) CONFIDENTIALITY.—Information submitted to 

17 the Secretary under this section that is confidential com18 mercial or trade secret information shall be exempt from 

19 disclosure under section 552 of title 5, United States 

20 Code, including all information submitted under sub21 section (b)(2)(D) or (c)(4)(A)(i). 

22 ‘‘(f) SUSPENSIONS.— 

23 ‘‘(1) SUSPENSION OF REGISTRATION OF A FA24 CILITY.—The Secretary may suspend the registra25 tion of a facility if the Secretary determines that a 


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1 cosmetic product manufactured or processed by a 

2 registered facility and distributed in the United 

3 States has a reasonable probability of causing seri4 ous adverse health consequences or death to humans 

5 and the Secretary has a reasonable belief that other 

6 products manufactured or processed by the facility 

7 may be similarly affected because of a failure that 

8 cannot be isolated to a product or products, or is 

9 sufficiently pervasive to raise concerns about other 

10 products manufactured in the facility. 

11 ‘‘(2) NOTICE OF SUSPENSION.—Before sus12 pending a facility registration under this section, the 

13 Secretary shall provide— 

14 ‘‘(A) notice to the facility registrant of the 

15 cosmetic product or other responsible person, as 

16 appropriate, of the intent to suspend the facility 

17 registration, which shall specify the basis of the 

18 determination by the Secretary that the facility 

19 should be suspended; and 

20 ‘‘(B) an opportunity, within 5 business 

21 days of the notice provided under subparagraph 

22 (A), for the responsible person to provide a plan 

23 for addressing the reasons for possible suspen24 sion of the facility registration. 


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1 ‘‘(3) HEARING ON SUSPENSION.—The Secretary 

2 shall provide the registrant subject to an order 

3 under paragraph (1) or (2) with an opportunity for 

4 an informal hearing, to be held as soon as possible 

5 but not later than 5 business days after the issuance 

6 of the order, or such other time period agreed upon 

7 by the Secretary and the registrant, on the actions 

8 required for reinstatement of registration and why 

9 the registration that is subject to the suspension 

10 should be reinstated. The Secretary shall reinstate a 

11 registration if the Secretary determines, based on 

12 evidence presented, that adequate grounds do not 

13 exist to continue the suspension of the registration. 

14 ‘‘(4) POST-HEARING CORRECTIVE ACTION

15 PLAN.—If, after providing opportunity for an infor16 mal hearing under paragraph (3), the Secretary de17 termines that the suspension of registration remains 

18 necessary, the Secretary shall require the registrant 

19 to submit a corrective action plan to demonstrate 

20 how the registrant plans to correct the conditions 

21 found by the Secretary. The Secretary shall review 

22 such plan not later than 14 business days after the 

23 submission of the corrective action plan or such 

24 other time period as determined by the Secretary, in 

25 consultation with the registrant. 


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1 ‘‘(5) VACATING OF ORDER; REINSTATEMENT.— 

2 Upon a determination by the Secretary that ade3 quate grounds do not exist to continue the suspen4 sion actions, the Secretary shall promptly vacate the 

5 suspension and reinstate the registration of the facil6 ity. 

7 ‘‘(6) EFFECT OF SUSPENSION.—If the registra8 tion of the facility is suspended under this section, 

9 no person shall introduce or deliver for introduction 

10 into commerce in the United States cosmetic prod11 ucts from such facility. 

12 ‘‘(7) NO DELEGATION.—The authority con13 ferred by this section to issue an order to suspend 

14 a registration or vacate an order of suspension shall 

15 not be delegated to any officer or employee other 

16 than the Commissioner. 

17 ‘‘SEC. 608. SAFETY SUBSTANTIATION. 

18 ‘‘(a) SUBSTANTIATION OF SAFETY.—A responsible 

19 person for a cosmetic product shall ensure, and maintain 

20 records supporting, that there is adequate substantiation 

21 of safety of such cosmetic product. 

22 ‘‘(b) COAL-TAR HAIR DYE.—Subsection (a) shall not 

23 apply to coal-tar hair dye that otherwise complies with the 

24 requirements of section 601(a). A responsible person for 


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1 a coal-tar hair dye shall maintain records related to the 

2 safety of such product. 

3 ‘‘(c) DEFINITIONS.—For purposes of this section: 

4 ‘‘(1) ADEQUATE SUBSTANTIATION OF SAFE5 TY.—The term ‘adequate substantiation of safety’ 

6 means tests or studies, research, analyses, or other 

7 evidence or information that is considered, among 

8 experts qualified by scientific training and experi9 ence to evaluate the safety of cosmetic products and 

10 their ingredients, sufficient to support a reasonable 

11 certainty that a cosmetic product is safe. 

12 ‘‘(2) SAFE.—The term ‘safe’ means that the 

13 cosmetic product, including any ingredient thereof, 

14 is not injurious to users under the conditions of use 

15 prescribed in the labeling thereof, or under such con16 ditions of use as are customary or usual. The Sec17 retary shall not consider a cosmetic ingredient or 

18 cosmetic product injurious to users solely because it 

19 can cause minor and transient reactions or minor 

20 and transient skin irritations in some users. In de21 termining for purposes of this section whether a cos22 metic product is safe, the Secretary may consider, as 

23 appropriate and available, the cumulative or other 

24 relevant exposure to the cosmetic product, including 

25 any ingredient thereof. 


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1 ‘‘SEC. 609. LABELING. 

2 ‘‘(a) GENERAL REQUIREMENT.—Each cosmetic prod3 uct shall bear a label that includes a domestic address, 

4 domestic phone number, or electronic contact information, 

5 which may include a website, through which the respon6 sible person can receive adverse event reports with respect 

7 to such cosmetic product. 

8 ‘‘(b) FRAGRANCE ALLERGENS.—The responsible per9 son shall identify on the label of a cosmetic product each 

10 fragrance allergen included in such cosmetic product. Sub11 stances that are fragrance allergens for purposes of this 

12 subsection shall be determined by the Secretary by regula13 tion. The Secretary shall issue a notice of proposed rule14 making promulgating the regulation implementing this re15 quirement not later than 18 months after the date of en16 actment of the Modernization of Cosmetics Regulation Act 

17 of 2022, and not later than 180 days after the date on 

18 which the public comment period on the proposed rule19 making closes, shall issue a final rulemaking. In promul20 gating regulations implementing this subsection, the Sec21 retary shall consider international, State, and local re22 quirements for allergen disclosure, including the substance 

23 and format of requirements in the European Union, and 

24 may establish threshold levels of amounts of substances 

25 subject to disclosure pursuant to such regulations. 


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1 ‘‘(c) COSMETIC PRODUCTS FOR PROFESSIONAL

2 USE.— 

3 ‘‘(1) DEFINITION OF PROFESSIONAL.—For pur4 poses of this subsection, the term ‘professional’ 

5 means an individual who is licensed by an official 

6 State authority to practice in the field of cosme7 tology, nail care, barbering, or esthetics. 

8 ‘‘(2) PROFESSIONAL USE LABELING.—A cos9 metic product introduced into interstate commerce 

10 and intended to be used only by a professional shall 

11 bear a label that— 

12 ‘‘(A) contains a clear and prominent state13 ment that the product shall be administered or 

14 used only by licensed professionals; and 

15 ‘‘(B) is in conformity with the require16 ments of the Secretary for cosmetics labeling 

17 under this Act and section 4(a) of the Fair 

18 Packaging and Labeling Act. 

19 ‘‘SEC. 610. RECORDS. 

20 ‘‘(a) IN GENERAL.—If the Secretary has a reasonable 

21 belief that a cosmetic product, including an ingredient in 

22 such cosmetic product, and any other cosmetic product 

23 that the Secretary reasonably believes is likely to be af24 fected in a similar manner, is likely to be adulterated such 

25 that the use or exposure to such product presents a threat 


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1 of serious adverse health consequences or death to hu2 mans, each responsible person and facility shall, at the re3 quest of an officer or employee duly designated by the Sec4 retary, permit such officer or employee, upon presentation 

5 of appropriate credentials and a written notice to such 

6 person, at reasonable times and within reasonable limits 

7 and in a reasonable manner, to have access to and copy 

8 all records relating to such cosmetic product, and to any 

9 other cosmetic product that the Secretary reasonably be10 lieves is likely to be affected in a similar manner, that 

11 are needed to assist the Secretary in determining whether 

12 the cosmetic product is adulterated and presents a threat 

13 of serious adverse health consequences or death to hu14 mans. This subsection shall not be construed to extend 

15 to recipes or formulas for cosmetics, financial data, pricing 

16 data, personnel data (other than data as to qualification 

17 of technical and professional personnel performing func18 tions subject to this Act), research data (other than safety 

19 substantiation data for cosmetic products and their ingre20 dients), or sales data (other than shipment data regarding 

21 sales). 

22 ‘‘(b) PROTECTION OF SENSITIVE INFORMATION.— 

23 The Secretary shall take appropriate measures to ensure 

24 that there are in effect effective procedures to prevent the 

25 unauthorized disclosure of any trade secret or confidential 


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1 information that is obtained by the Secretary pursuant to 

2 this section. 

3 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to limit the authority of the Sec5 retary to inspect records or require establishment and 

6 maintenance of records under any other provision of this 

7 Act, including section 605 or 606. 

8 ‘‘SEC. 611. MANDATORY RECALL AUTHORITY. 

9 ‘‘(a) IN GENERAL.—If the Secretary determines that 

10 there is a reasonable probability that a cosmetic is adulter11 ated under section 601 or misbranded under section 602 

12 and the use of or exposure to such cosmetic will cause 

13 serious adverse health consequences or death, the Sec14 retary shall provide the responsible person with an oppor15 tunity to voluntarily cease distribution and recall such ar16 ticle. If the responsible person refuses to or does not vol17 untarily cease distribution or recall such cosmetic within 

18 the time and manner prescribed by the Secretary (if so 

19 prescribed), the Secretary may, by order, require, as the 

20 Secretary deems necessary, such person to immediately 

21 cease distribution of such article. 

22 ‘‘(b) HEARING.—The Secretary shall provide the re23 sponsible person who is subject to an order under sub24 section (a) with an opportunity for an informal hearing, 

25 to be held not later than 10 days after the date of issuance 


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1 of the order, on whether adequate evidence exists to justify 

2 the order. 

3 ‘‘(c) ORDER RESOLUTION.—After an order is issued 

4 according to the process under subsections (a) and (b), 

5 the Secretary shall, except as provided in subsection (d)— 

6 ‘‘(1) vacate the order, if the Secretary deter7 mines that inadequate grounds exist to support the 

8 actions required by the order; 

9 ‘‘(2) continue the order ceasing distribution of 

10 the cosmetic until a date specified in such order; or 

11 ‘‘(3) amend the order to require a recall of the 

12 cosmetic, including any requirements to notify ap13 propriate persons, a timetable for the recall to occur, 

14 and a schedule for updates to be provided to the 

15 Secretary regarding such recall. 

16 ‘‘(d) ACTION FOLLOWING ORDER.—Any person who 

17 is subject to an order pursuant to paragraph (2) or (3) 

18 of subsection (c) shall immediately cease distribution of 

19 or recall, as applicable, the cosmetic and provide notifica20 tion as required by such order. 

21 ‘‘(e) NOTICE TO PERSONS AFFECTED.—If the Sec22 retary determines necessary, the Secretary may require 

23 the person subject to an order pursuant to subsection (a) 

24 or an amended order pursuant to paragraph (2) or (3) 

25 of subsection (c) to provide either a notice of a recall order 


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1 for, or an order to cease distribution of, such cosmetic, 

2 as applicable, under this section to appropriate persons, 

3 including persons who manufacture, distribute, import, or 

4 offer for sale such product that is the subject of an order 

5 and to the public. 

6 ‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 

7 under this section, the Secretary shall— 

8 ‘‘(1) ensure that a press release is published re9 garding the recall, and that alerts and public notices 

10 are issued, as appropriate, in order to provide notifi11 cation— 

12 ‘‘(A) of the recall to consumers and retail13 ers to whom such cosmetic was, or may have 

14 been, distributed; and 

15 ‘‘(B) that includes, at a minimum— 

16 ‘‘(i) the name of the cosmetic subject 

17 to the recall; 

18 ‘‘(ii) a description of the risk associ19 ated with such article; and 

20 ‘‘(iii) to the extent practicable, infor21 mation for consumers about similar cos22 metics that are not affected by the recall; 

23 and 

24 ‘‘(2) ensure publication, as appropriate, on the 

25 website of the Food and Drug Administration of an 


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1 image of the cosmetic that is the subject of the press 

2 release described in paragraph (1), if available. 

3 ‘‘(g) NO DELEGATION.—The authority conferred by 

4 this section to order a recall or vacate a recall order shall 

5 not be delegated to any officer or employee other than the 

6 Commissioner. 

7 ‘‘(h) EFFECT.—Nothing in this section shall affect 

8 the authority of the Secretary to request or participate 

9 in a voluntary recall, or to issue an order to cease distribu10 tion or to recall under any other provision of this chapter. 

11 ‘‘SEC. 612. SMALL BUSINESSES. 

12 ‘‘(a) IN GENERAL.—Responsible persons, and owners 

13 and operators of facilities, whose average gross annual 

14 sales in the United States of cosmetic products for the 

15 previous 3-year period is less than $1,000,000, adjusted 

16 for inflation, and who do not engage in the manufacturing 

17 or processing of the cosmetic products described in sub18 section (b), shall be considered small businesses and not 

19 subject to the requirements of section 606 or 607. 

20 ‘‘(b) REQUIREMENTS APPLICABLE TO ALL MANU21 FACTURERS AND PROCESSORS OF COSMETICS.—The ex22 emptions under subsection (a) shall not apply to any re23 sponsible person or facility engaged in the manufacturing 

24 or processing of any of the following products: 


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1 ‘‘(1) Cosmetic products that regularly come into 

2 contact with mucus membrane of the eye under con3 ditions of use that are customary or usual. 

4 ‘‘(2) Cosmetic products that are injected. 

5 ‘‘(3) Cosmetic products that are intended for 

6 internal use. 

7 ‘‘(4) Cosmetic products that are intended to 

8 alter appearance for more than 24 hours under con9 ditions of use that are customary or usual and re10 moval by the consumer is not part of such conditions 

11 of use that are customary or usual. 

12 ‘‘SEC. 613. EXEMPTION FOR CERTAIN PRODUCTS AND FA13 CILITIES. 

14 ‘‘(a) IN GENERAL.—Notwithstanding any other pro15 vision of law, except as provided in subsection (b), a cos16 metic product or facility that is also subject to the require17 ments of chapter V shall be exempt from the requirements 

18 of sections 605, 606, 607, 608, 609(a), 610, and 611. 

19 ‘‘(b) EXCEPTION.—A facility described in subsection 

20 (a) that also manufactures or processes cosmetic products 

21 that are not subject to the requirements of chapter V shall 

22 not be exempt from the requirements of sections 605, 606, 

23 607, 608, 609(a), 610, and 611, with respect to such cos24 metic products. 


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1 ‘‘SEC. 614. PREEMPTION. 

2 ‘‘(a) IN GENERAL.—No State or political subdivision 

3 of a State may establish or continue in effect any law, 

4 regulation, order, or other requirement for cosmetics that 

5 is different from or in addition to, or otherwise not iden6 tical with, any requirement applicable under this chapter 

7 with respect to registration and product listing, good man8 ufacturing practice, recordkeeping, recalls, adverse event 

9 reporting, or safety substantiation. 

10 ‘‘(b) LIMITATION.—Nothing in the amendments to 

11 this Act made by the Modernization of Cosmetics Regula12 tion Act of 2022 shall be construed to preempt any State 

13 statute, public initiative, referendum, regulation, or other 

14 State action, except as expressly provided in subsection 

15 (a). Notwithstanding subsection (a), nothing in this sec16 tion shall be construed to prevent any State from prohib17 iting the use or limiting the amount of an ingredient in 

18 a cosmetic product, or from continuing in effect a require19 ment of any State that is in effect at the time of enact20 ment of the Modernization of Cosmetics Regulation Act 

21 of 2022 for the reporting to the State of an ingredient 

22 in an cosmetic product. 

23 ‘‘(c) SAVINGS.—Nothing in the amendments to this 

24 Act made by the Modernization of Cosmetics Regulation 

25 Act of 2022, nor any standard, rule, requirement, regula26 tion, or adverse event report shall be construed to modify, 


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1 preempt, or displace any action for damages or the liabil2 ity of any person under the law of any State, whether stat3 utory or based in common law. 

4 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec5 tion shall be construed to amend, expand, or limit the pro6 visions under section 752.’’. 

7 SEC. 803. ENFORCEMENT AND CONFORMING AMEND8 MENTS. 

9 (a) IN GENERAL.— 

10 (1) PROHIBITED ACTS.—Section 301 of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

12 331) is amended— 

13 (A) by adding at the end the following: 

14 ‘‘(fff) The failure to register or submit listing infor15 mation in accordance with section 607. 

16 ‘‘(ggg) The refusal or failure to follow an order under 

17 section 611.’’; and 

18 (B) in paragraph (d), by striking ‘‘or 564’’ 

19 and inserting ‘‘, 564, or 607’’. 

20 (2) ADULTERATED PRODUCTS.—Section 601 of 

21 the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 361) is amended by adding at the end the 

23 following: 

24 ‘‘(f) If it has been manufactured or processed under 

25 conditions that do not meet good manufacturing practice 


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1 regulations, as prescribed by the Food and Drug Adminis2 tration in accordance with section 606. 

3 ‘‘(g) If it is a cosmetic product, and the cosmetic 

4 product, including each ingredient in the cosmetic product, 

5 does not have adequate substantiation for safety, as de6 fined in section 608(c).’’. 

7 (3) MISBRANDED COSMETICS.—Section 602(b) 

8 of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 362(b)) is amended— 

10 (A) by striking ‘‘and (2)’’ and inserting 

11 ‘‘(2)’’; and 

12 (B) by inserting after ‘‘numerical count’’ 

13 the following: ‘‘; and (3) the information re14 quired under section 609’’. 

15 (4) ADVERSE EVENT REPORTING.—The Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

17 seq.) is amended— 

18 (A) in section 301(e) (21 U.S.C. 331(e))— 

19 (i) by striking ‘‘564, 703’’ and insert20 ing ‘‘564, 605, 703’’; and 

21 (ii) by striking ‘‘564, 760’’ and insert22 ing ‘‘564, 605, 611, 760’’; 

23 (B) in section 301(ii) (21 U.S.C. 

24 331(ii))— 


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1 (i) by striking ‘‘760 or 761) or’’ and 

2 inserting ‘‘604, 760, or 761) or’’; and 

3 (ii) by inserting ‘‘or required under 

4 section 605(a)’’ after ‘‘report (as defined 

5 under section 760 or 761’’; 

6 (C) in section 801(a) (21 U.S.C. 381(a))— 

7 (i) by striking ‘‘under section 760 or 

8 761’’ and inserting ‘‘under section 605, 

9 760, or 761’’; 

10 (ii) by striking ‘‘defined in such sec11 tion 760 or 761’’ and inserting ‘‘defined in 

12 section 604, 760, or 761’’; 

13 (iii) by striking ‘‘of such section 760 

14 or 761’’ and inserting ‘‘of such section 

15 605, 760, or 761’’; and 

16 (iv) by striking ‘‘described in such 

17 section 760 or 761’’ and inserting ‘‘de18 scribed in such section 605, 760, or 761’’; 

19 and 

20 (D) in section 801(b) (21 U.S.C. 

21 381(b))— 

22 (i) by striking ‘‘requirements of sec23 tions 760 or 761,’’ and inserting ‘‘require24 ments of section 605, 760, or 761’’; 


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1 (ii) by striking ‘‘as defined in section 

2 760 or 761’’ and inserting ‘‘as defined in 

3 section 604, 760, or 761’’; and 

4 (iii) by striking ‘‘with section 760 or 

5 761’’ and inserting ‘‘with section 605, 760, 

6 or 761’’. 

7 (b) EFFECTIVE DATE.—The amendments made by 

8 subsection (a) shall take effect on the date that is 1 year 

9 after the date of enactment of this Act. 

10 SEC. 804. RECORDS INSPECTION. 

11 Section 704(a)(1) of the Federal Food, Drug, and 

12 Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by insert13 ing after the second sentence the following: ‘‘In the case 

14 of a facility (as defined in section 604) that manufactures 

15 or processes cosmetic products, the inspection shall extend 

16 to all records and other information described in sections 

17 605, 606, and 610, when the standard for records inspec18 tion under such section applies.’’. 

19 SEC. 805. TALC-CONTAINING COSMETICS. 

20 The Secretary of Health and Human Services— 

21 (1) not later than one year after the date of en22 actment of this Act, shall promulgate proposed regu23 lations to establish and require standardized testing 

24 methods for detecting and identifying asbestos in 

25 talc-containing cosmetic products; and 


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1 (2) not later than 180 days after the date on 

2 which the public comment period on the proposed 

3 regulations closes, shall issue such final regulations. 

4 SEC. 806. PFAS IN COSMETICS. 

5 (a) IN GENERAL.—The Secretary of Health and 

6 Human Services (referred to in this section as the ‘‘Sec7 retary’’) shall assess the use of perfluoroalkyl and 

8 polyfluoroalkyl substances in cosmetic products and the 

9 scientific evidence regarding the safety of such use in cos10 metic products, including any risks associated with such 

11 use. In conducting such assessment, the Secretary may, 

12 as appropriate, consult with the National Center for Toxi13 cological Research. 

14 (b) REPORT.—Not later than 2 years after enactment 

15 of this Act, the Secretary shall publish on the website of 

16 the Food and Drug Administration a report summarizing 

17 the results of the assessment conducted under subsection 

18 (a). 

19 SEC. 807. FUNDING. 

20 There is authorized to be appropriated $14,200,000 

21 for fiscal year 2023, $25,960,000 for fiscal year 2024, and 

22 $41,890,000 for each of the fiscal years 2025 through 

23 2027, for purposes of conducting the activities under this 

24 subtitle (including the amendments made by this subtitle) 


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1 and hiring personnel required to carry out this subtitle 

2 (including the amendments made by this subtitle). 

3 Subtitle B—Dietary Supplements 

4 SEC. 811. REGULATION OF DIETARY SUPPLEMENTS. 

5 (a) IN GENERAL.—Chapter IV of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend7 ed by adding after section 403C of such Act (21 U.S.C. 

8 343–3) the following: 

9 ‘‘SEC. 403D. DIETARY SUPPLEMENT LISTING REQUIRE10 MENT. 

11 ‘‘(a) IN GENERAL.—Beginning on the date specified 

12 in subsection (b)(4), each dietary supplement shall be list13 ed with the Secretary in accordance with this section. 

14 Each such listing shall include, with respect to the dietary 

15 supplement, the information specified in subsection (b)(1). 

16 ‘‘(b) REQUIREMENTS.— 

17 ‘‘(1) IN GENERAL.—The manufacturer, packer, 

18 or distributor of a dietary supplement whose name 

19 (pursuant to section 403(e)(1)) appears on the label 

20 of a dietary supplement marketed in the United 

21 States (referred to in this section as the ‘responsible 

22 person’), or if the responsible person is a foreign en23 tity, the United States agent of such person, shall 

24 submit to the Secretary in accordance with this secVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00132 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 tion the following information for a dietary supple2 ment that is marketed: 

3 ‘‘(A) Any name of the dietary supplement 

4 and the statement of identity, including brand 

5 name and specified flavors, if applicable. 

6 ‘‘(B) The name and address of the respon7 sible person and the name and email address of 

8 the owner, operator, or agent in charge of the 

9 responsible person. 

10 ‘‘(C) The name, domestic address, and 

11 email address for the United States agent, if 

12 the responsible person is a foreign entity. 

13 ‘‘(D) The business name and mailing ad14 dress of all locations at which the responsible 

15 person manufactures, packages, labels, or holds 

16 the dietary supplement. 

17 ‘‘(E) A list of all ingredients in each such 

18 dietary supplement required under sections 

19 101.4 and 101.36, title 21, Code of Federal 

20 Regulations (or any successor regulations) to 

21 appear on the label of a dietary supplement, in22 cluding— 

23 ‘‘(i) where applicable, ingredients in a 

24 proprietary blend as described in section 


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1 101.36(c) of title 21, Code of Federal Reg2 ulations (or any successor regulations); 

3 ‘‘(ii) the amount per serving of each 

4 listed dietary ingredient; 

5 ‘‘(iii) if required by section 101.36 of 

6 title 21, Code of Federal Regulations (or 

7 any successor regulations), the percent of 

8 the daily value of each listed dietary ingre9 dient; and 

10 ‘‘(iv) the amount per serving of die11 tary ingredients within a proprietary blend. 

12 ‘‘(F) The number of servings per container 

13 for each container size of the identical formula14 tion. 

15 ‘‘(G) The directions for use. 

16 ‘‘(H) Warnings, notice, and safe handling 

17 statements, as required by section 101.17 of 

18 title 21, Code of Federal Regulations (or any 

19 successor regulations). 

20 ‘‘(I) Allergen statements for major food al21 lergens (pursuant to sections 403(w) and 

22 403(x)). 

23 ‘‘(J) The form of the dietary supplement 

24 (such as tablets, capsules). 


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1 ‘‘(K) Any health claims or structure or 

2 function claims. 

3 ‘‘(L) The dietary supplement product list4 ing number for the product provided by the 

5 Secretary in accordance with subsection (c) for 

6 that product. 

7 ‘‘(2) FORMAT.—The Secretary may require that 

8 a listing submitted under paragraph (1) be sub9 mitted in an electronic format. Upon receipt of a 

10 complete listing under paragraph (1), the Secretary 

11 shall promptly notify the responsible person of the 

12 receipt of such listing. 

13 ‘‘(3) LISTING CONTENT.—A single listing sub14 mission for a dietary supplement under paragraph 

15 (1) may include multiple dietary supplements with 

16 identical formulations, or formulations that differ 

17 only with respect to color, additives, or flavorings, 

18 whether offered in a single package size or in mul19 tiple package sizes. 

20 ‘‘(4) TIMING.— 

21 ‘‘(A) IN GENERAL.— 

22 ‘‘(i) DIETARY SUPPLEMENTS ON THE

23 MARKET.—In the case of a dietary supple24 ment that is being offered in interstate 

25 commerce on or before January 1, 2024, a 


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1 listing for each such dietary supplement in2 troduced or delivered for introduction into 

3 interstate commerce shall be submitted by 

4 the responsible person to the Secretary 

5 under this subsection not later than 18 

6 months after the date of enactment of the 

7 Food and Drug Administration Safety and 

8 Landmark Advancements Act of 2022. 

9 ‘‘(ii) NEW DIETARY SUPPLEMENTS.— 

10 In the case of a dietary supplement that is 

11 not being offered in interstate commerce 

12 on or before January 1, 2024, a listing for 

13 each such dietary supplement introduced 

14 or delivered for introduction into interstate 

15 commerce that has not been included in 

16 any listing previously submitted by the re17 sponsible person to the Secretary under 

18 this subsection shall be submitted to the 

19 Secretary at the time of introduction into 

20 interstate commerce. 

21 ‘‘(B) DISCONTINUED DIETARY SUPPLE22 MENTS.—The responsible person shall notify 

23 the Secretary within one year of the date of dis24 continuance of a dietary supplement required to 

25 be listed with the Secretary under paragraph 


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1 (1) for which the responsible person has discon2 tinued commercial marketing. 

3 ‘‘(C) CHANGES TO EXISTING LISTINGS.— 

4 The responsible person shall submit to the Sec5 retary a change or modification to listing infor6 mation submitted under paragraph (1) included 

7 on the label for a dietary supplement at the 

8 time the dietary supplement with the change or 

9 modification is introduced into interstate com10 merce. 

11 ‘‘(5) ADDITIONAL INFORMATION.—The respon12 sible person shall provide upon request from the Sec13 retary, within 10 calendar days of such request, the 

14 full business name and physical and mailing address 

15 from which the responsible person receives a dietary 

16 ingredient or combination of dietary ingredients that 

17 the responsible person uses in the manufacture of 

18 the dietary supplement or, if applicable, from which 

19 the responsible person receives the dietary supple20 ment. 

21 ‘‘(c) PRODUCT LISTING NUMBER AND DIETARY SUP22 PLEMENT ELECTRONIC DATABASE.— 

23 ‘‘(1) DIETARY SUPPLEMENT PRODUCT LISTING

24 NUMBER.—The Secretary shall provide each dietary 

25 supplement listed in accordance with subsection 


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1 (b)(1) a dietary supplement product listing number, 

2 which may apply to multiple dietary supplements 

3 with identical formulations, or formulations that dif4 fer only with respect to color, additives, or 

5 flavorings, including dietary supplements offered in 

6 a single package size or in multiple package sizes. 

7 The Secretary shall provide a process for a respon8 sible person to reserve dietary supplement listing 

9 numbers in advance of listing under subsection 

10 (b)(1). 

11 ‘‘(2) ELECTRONIC DATABASE.—Not later than 

12 2 years after the date of enactment of the Food and 

13 Drug Administration Safety and Landmark Ad14 vancements Act of 2022, the Secretary shall estab15 lish and maintain an electronic database that is pub16 licly available and contains information submitted 

17 under subsection (b)(1) (except for the information 

18 submitted under subparagraphs (D) and (E)(iv) of 

19 such subsection). The Secretary shall make such in20 formation maintained in the electronic database pub21 licly searchable, including by dietary supplement 

22 product listing number, and by any field of informa23 tion or combination of fields of information provided 

24 under subsection (b)(1). 


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1 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed— 

3 ‘‘(1) to limit the authority of the Secretary to 

4 inspect or copy records or to require the establish5 ment and maintenance of records under any other 

6 provision of this Act; or 

7 ‘‘(2) to authorize the disclosure of trade secret 

8 or confidential commercial information subject to 

9 section 552(b)(4) of title 5, United States Code, as 

10 prohibited under section 301(j) of this Act or section 

11 1905 of title 18, United States Code, including in12 formation provided to the Secretary under sub13 section (b)(1)(D) or (b)(1)(E)(iv). 

14 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

15 is authorized to be appropriated $7,498,080 for fiscal year 

16 2023, and $6,300,000 for each of fiscal years 2024 

17 through 2027, for purposes of conducting the activities 

18 under this section and hiring personnel required to carry 

19 out this section.’’. 

20 (b) GUIDANCE.—Not later than 18 months after the 

21 date of enactment of this Act, the Secretary of Health and 

22 Human Services shall publish final guidance related to the 

23 draft guidance titled, ‘‘Dietary Supplements: New Dietary 

24 Ingredient Notifications and Related Issues; Revised 

25 Draft Guidance for Industry; Availability’’ (81 Fed. Reg. 


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1 53486; August 12, 2016), consistent with section 403D 

2 of the Federal Food, Drug, and Cosmetic Act, as added 

3 by subsection (a). 

4 (c) INSPECTIONS FOR CERTAIN DIETARY SUPPLE5 MENTS.—The Secretary of Health and Human Services 

6 shall direct resources to inspections of facilities, suppliers, 

7 and dietary supplement types that present a high risk to 

8 public health (as identified by the Secretary). 

9 (d) MISBRANDING.—Section 403 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend11 ed by adding at the end the following: 

12 ‘‘(z) If it is a dietary supplement for which a respon13 sible person is required under section 403D to file a list14 ing, file a change to an existing listing, or provide addi15 tional information to the Secretary, and such person has 

16 failed to comply with any such requirements under section 

17 403D with respect to such dietary supplement.’’. 

18 (e) NEW PROHIBITED ACT.—Section 301 of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 

20 amended by section 803(a), is further amended by adding 

21 at the end the following: 

22 ‘‘(hhh) The introduction or delivery for introduction 

23 into interstate commerce of any product marketed as a 

24 dietary supplement that does not meet the definition of 

25 a dietary supplement under section 201(ff). 


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1 ‘‘(iii) The introduction or delivery for introduction 

2 into interstate commerce of a dietary supplement that has 

3 been prepared, packed, or held using the assistance of, or 

4 at the direction of, a person debarred under section 306.’’. 

5 Subtitle C—In Vitro Clinical Tests 

6 SEC. 821. SHORT TITLE; TABLE OF CONTENTS. 

7 (a) SHORT TITLE.—This subtitle may be cited as the 

8 ‘‘Food and Drug Administration Safety and Landmark 

9 Advancements Act of 2022’’ or the ‘‘VALID Act of 2022’’. 

10 (b) TABLE OF CONTENTS.—The table of contents of 

11 this subtitle is as follows: 

SUBCHAPTER C—IN VITRO CLINICAL TESTS

Sec. 821. Short title; table of contents. 

Sec. 822. Definitions. 

Sec. 823. Regulation of in vitro clinical tests. 

‘‘SUBCHAPTER J—IN VITRO CLINICAL TESTS

‘‘SUBCHAPTER J. In Vitro Clinical Tests 

‘‘Sec. 587. Definitions. 

‘‘Sec. 587A. Regulation of in vitro clinical tests. 

‘‘Sec. 587B. Premarket review. 

‘‘Sec. 587C. Exemptions. 

‘‘Sec. 587D. Technology certification. 

‘‘Sec. 587E. Mitigating measures. 

‘‘Sec. 587F. Regulatory pathway designation. 

‘‘Sec. 587G. Grandfathered in vitro clinical tests. 

‘‘Sec. 587H. Advisory committees. 

‘‘Sec. 587I. Breakthrough in vitro clinical tests. 

‘‘Sec. 587J. Registration and listing. 

‘‘Sec. 587K. Test design and quality requirements. 

‘‘Sec. 587L. Labeling requirements. 

‘‘Sec. 587M. Adverse event reporting. 

‘‘Sec. 587N. Corrections and removals. 

‘‘Sec. 587O. Restricted in vitro clinical tests. 

‘‘Sec. 587P. Appeals. 

‘‘Sec. 587Q. Accredited persons. 

‘‘Sec. 587R. Recognized standards. 

‘‘Sec. 587S. Investigational use. 

‘‘Sec. 587T. Collaborative communities for in vitro clinical tests. 

‘‘Sec. 587U. Comprehensive test information system. 

‘‘Sec. 587V. Preemption. 


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‘‘Sec. 587W. Adulteration. 

‘‘Sec. 587X. Misbranding. 

‘‘Sec. 587Y. Postmarket surveillance. 

‘‘Sec. 587Z. Electronic format for submissions. 

‘‘Sec. 587AA. Postmarket remedies. 

‘‘Sec. 587BB. Applicability. 

‘‘Sec. 587CC. Judicial review. 

Sec. 824. Enforcement and other provisions. 

Sec. 825. Transition. 

Sec. 826. Emergency use authorization. 

Sec. 827. Antimicrobial susceptibility tests. 

Sec. 828. Combination products. 

Sec. 829. Resources. 

1 SEC. 822. DEFINITIONS. 

2 (a) IN GENERAL.—Section 201 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 321) is amended— 

4 (1) by adding at the end the following: 

5 ‘‘(ss)(1) The term ‘in vitro clinical test’ means an ar6 ticle specified in subparagraph (2) that is intended by its 

7 developer (as defined in section 587) to be used in the 

8 collection, preparation, analysis, or in vitro clinical exam9 ination of specimens taken or derived from the human 

10 body for the purpose of— 

11 ‘‘(A) identifying or diagnosing a disease or con12 dition; 

13 ‘‘(B) providing information for diagnosing, 

14 screening, measuring, detecting, predicting, 

15 prognosing, analyzing, or monitoring a disease or 

16 condition, including by making a determination of 

17 an individual’s state of health; or 

18 ‘‘(C) selecting, monitoring, or informing ther19 apy or treatment for a disease or condition. 


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1 ‘‘(2) An article specified in this subparagraph is— 

2 ‘‘(A) a test kit; 

3 ‘‘(B) a test system; 

4 ‘‘(C) a test protocol or laboratory test protocol; 

5 ‘‘(D) an instrument (as defined in section 

6 587(11)); 

7 ‘‘(E) a specimen receptacle (as defined in sec8 tion 587(17)); 

9 ‘‘(F) software, excluding software that is ex10 cluded by section 520(o) from the definition of a de11 vice under section 201(h), that— 

12 ‘‘(i) is a component or part of another in 

13 vitro clinical test or analyzes, processes, or in14 terprets a signal or pattern from another in 

15 vitro clinical test; and 

16 ‘‘(ii) does not analyze, process, or interpret 

17 a signal, pattern, or medical image from a de18 vice; and 

19 ‘‘(G) subject to subparagraph (3), a component 

20 or part of a test, a test protocol, an instrument, an 

21 article, or software described in any of clauses (A) 

22 through (D) of such subparagraph, whether alone or 

23 in combination, including reagents, calibrators, and 

24 controls. 


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1 ‘‘(3) Notwithstanding subparagraph (2)(G), an arti2 cle intended to be used as a component or part of an in 

3 vitro clinical test described in subparagraph (1) is ex4 cluded from the definition in subparagraph (1) if the arti5 cle consists of any of the following: 

6 ‘‘(A) Blood, blood components, or human cells 

7 or tissues, from the time of acquisition, donation, or 

8 recovery of such article, including determination of 

9 donor eligibility, as applicable, until such time as the 

10 article is released as a component or part of an in 

11 vitro clinical test by the establishment that collected 

12 such article. 

13 ‘‘(B) An article used for invasive sampling, a 

14 needle, or a lancet, except to the extent such article, 

15 needle, or lancet is an integral component of an arti16 cle for holding, storing, or transporting a specimen. 

17 ‘‘(C) General purpose laboratory equipment, in18 cluding certain pre-analytical equipment, as deter19 mined by the Secretary. 

20 ‘‘(D) An article used solely for personal protec21 tion during the administering, conducting, or other22 wise performing of test activities.’’; 

23 (2) by adding at the end of section 201(g) the 

24 following: 


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1 ‘‘(3) The term ‘drug’ does not include an in vitro clin2 ical test.’’; and 

3 (3) in section 201(h)(1), in the matter following 

4 clause (C), by striking ‘‘section 520(o)’’ and insert5 ing ‘‘section 520(o) or an in vitro clinical test’’. 

6 (b) EXCLUSION FROM DEFINITION OF BIOLOGICAL

7 PRODUCT.—Section 351(i)(1) of the Public Health Serv8 ice Act (42 U.S.C. 262(i)(1)) is amended— 

9 (1) by striking ‘‘(1) The term ‘biological prod10 uct’ means’’ and inserting ‘‘(1)(A) The term ‘biologi11 cal product’ means’’; and 

12 (2) by adding at the end the following: 

13 ‘‘(B) The term ‘biological product’ does not in14 clude an in vitro clinical test as defined in section 

15 201(ss) of the Federal Food, Drug, and Cosmetic 

16 Act.’’. 

17 (c) IN VITRO CLINICAL TEST DEFINITION.—In this 

18 Act, the term ‘‘in vitro clinical test’’ has the meaning given 

19 such term in section 201(ss) of the Federal Food, Drug, 

20 and Cosmetic Act, as added by subsection (a). 

21 SEC. 823. REGULATION OF IN VITRO CLINICAL TESTS. 

22 The Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 301 et seq.) is amended— 


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1 (1) by amending the heading of chapter V to 

2 read as follows: ‘‘DRUGS, DEVICES, AND IN 

3 VITRO CLINICAL TESTS’’; and 

4 (2) by adding at the end of chapter V the fol5 lowing: 

6 ‘‘Subchapter J—In Vitro Clinical Tests 

7 ‘‘SEC. 587. DEFINITIONS. 

8 ‘‘In this subchapter: 

9 ‘‘(1) ANALYTICAL VALIDITY.—The term ‘ana10 lytical validity’ means, with respect to an in vitro 

11 clinical test, the ability of the in vitro clinical test, 

12 to identify, measure, detect, calculate, or analyze (or 

13 assist in such identification, measurement, detection, 

14 calculation, or analysis of) one or more analytes, bio15 markers, substances, or other targets intended to be 

16 identified, measured, detected, calculated, or ana17 lyzed by the test. 

18 ‘‘(2) APPLICABLE STANDARD.—The term ‘ap19 plicable standard’, with respect to an in vitro clinical 

20 test, means a reasonable assurance of analytical and 

21 clinical validity for its indications for use, and a rea22 sonable assurance of safety for individuals who come 

23 into contact with such in vitro clinical test, except 

24 that such term, with respect to specimen receptacles 

25 and test instruments, means a reasonable assurance 


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1 of analytical validity for its indications for use and 

2 safety for individuals who come into contact with 

3 such specimen receptacle or test instrument. 

4 ‘‘(3) CLINICAL USE.—The term ‘clinical use’ 

5 means the operation, application, or functioning of 

6 an in vitro clinical test for the purpose for which it 

7 is intended as described in section 201(ss)(1). 

8 ‘‘(4) CLINICAL VALIDITY.—The term ‘clinical 

9 validity’ means the ability of an in vitro clinical test 

10 to achieve the purpose for which it is intended as de11 scribed in section 201(ss)(1). 

12 ‘‘(5) COMPONENT OR PART.—The term ‘compo13 nent or part’ means a substance, piece, part, raw 

14 material, software, firmware, labeling, or assembly, 

15 including reagents, that is intended by the developer 

16 to be included as an aspect of an in vitro clinical test 

17 described in section 201(ss)(1). 

18 ‘‘(6) DEVELOP.—The term ‘develop’, with re19 spect to an in vitro clinical test, means— 

20 ‘‘(A) designing, validating, producing, 

21 manufacturing, remanufacturing, labeling, ad22 vertising, propagating, or assembling an in vitro 

23 clinical test; 

24 ‘‘(B) modifying an in vitro clinical test, in25 cluding modifying the indications for use of the 


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1 in vitro clinical test, or modifying an article to 

2 be in an in vitro clinical test; or 

3 ‘‘(C) establishing a test system as de4 scribed or included in a test protocol developed 

5 by another entity unless such test protocol is 

6 listed as an in vitro clinical test in the com7 prehensive test information system established 

8 under section 587T by that other entity. 

9 ‘‘(7) DEVELOPER.—The term ‘developer’ means 

10 a person who engages in development as described in 

11 paragraph (6), except the term does not include a 

12 laboratory that— 

13 ‘‘(A) is certified by the Secretary under 

14 section 353 of the Public Health Service Act; 

15 and 

16 ‘‘(B) assembles for use solely within that 

17 laboratory, without otherwise developing, an in 

18 vitro clinical test appropriately listed in the 

19 comprehensive test information system estab20 lished under section 587T by a different person. 

21 ‘‘(8) FIRST-OF-A-KIND.—The term ‘first-of-a22 kind’, with respect to an in vitro clinical test, means 

23 that such test has any novel combination of the ele24 ments specified in paragraph (10) that differs from 

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1 able in the United States, except for such tests of2 fered under section 587C(a)(3), 587C(a)(4), or 

3 587G. 

4 ‘‘(9) HIGH-RISK.—The term ‘high-risk’, with 

5 respect to an in vitro clinical test or category of in 

6 vitro clinical tests, means that an undetected inac7 curate result from such test, or such category of 

8 tests, when used as intended— 

9 ‘‘(A)(i) has the substantial likelihood to re10 sult in serious or irreversible harm or death to 

11 a patient or patients, or would otherwise cause 

12 serious harm to the public health; or 

13 ‘‘(ii) is reasonably likely to result in the 

14 absence, significant delay, or discontinuation of 

15 life-supporting or life-sustaining medical treat16 ment; and 

17 ‘‘(B) sufficient mitigating measures are 

18 not able to be established and applied to pre19 vent, mitigate, or detect the inaccurate result, 

20 or otherwise mitigate the risk resulting from an 

21 undetected inaccurate result described in sub22 paragraph (A), such that the test would be 

23 moderate-risk or low-risk. 


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1 ‘‘(10) INDICATIONS FOR USE.—The term ‘indi2 cations for use’, with respect to an in vitro clinical 

3 test, means the following elements: 

4 ‘‘(A) Substance or substances measured by 

5 the in vitro clinical test, such as an analyte, 

6 protein, or pathogen. 

7 ‘‘(B) Test method. 

8 ‘‘(C) Test purpose or purposes, as de9 scribed in section 201(ss)(1). 

10 ‘‘(D) Diseases or conditions for which the 

11 in vitro clinical test is intended for use, includ12 ing intended patient populations. 

13 ‘‘(E) Context of use, such as in a clinical 

14 laboratory, in a health care facility, prescription 

15 home use, over-the-counter use, or direct-to16 consumer testing. 

17 ‘‘(11) INSTRUMENT.— 

18 ‘‘(A) IN GENERAL.—The term ‘instrument’ 

19 means an analytical or pre-analytical instru20 ment. 

21 ‘‘(B) ANALYTIC INSTRUMENT.—The term 

22 ‘analytic instrument’ means an in vitro clinical 

23 test that is hardware intended by the hardware 

24 developer to be used with one or more other in 

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1 sult, including software used to effectuate the 

2 functionality of the hardware. 

3 ‘‘(C) PRE-ANALYTICAL INSTRUMENT.—The 

4 term ‘pre-analytical instrument’ means an in 

5 vitro clinical test that is hardware intended by 

6 the hardware’s developer solely to generate an 

7 output for use exclusively with one or more ana8 lytical instruments as defined in subparagraph 

9 (B) and which does not itself generate a clinical 

10 test result. Such term may include software 

11 used to effectuate the hardware’s functionality. 

12 ‘‘(12) INSTRUMENT FAMILY.—The term ‘instru13 ment family’ means more than one instrument devel14 oped by the same developer for which the developer 

15 demonstrates and documents, with respect to all 

16 such instruments, that all— 

17 ‘‘(A) have the same basic architecture, de18 sign, and performance characteristics; 

19 ‘‘(B) have the same indications for use and 

20 capabilities; 

21 ‘‘(C) share the same measurement prin22 ciples, detection methods, and reaction condi23 tions, as applicable; and 


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1 ‘‘(D) produce the same or similar analyt2 ical results from samples of the same specimen 

3 type or types. 

4 ‘‘(13) LOW-RISK.—The term ‘low-risk’, with re5 spect to an in vitro clinical test or category of in 

6 vitro clinical tests, means that an undetected inac7 curate result from such in vitro clinical test, or such 

8 category of in vitro clinical tests, when used as in9 tended— 

10 ‘‘(A) would cause only minimal or imme11 diately reversible harm, and would lead to only 

12 a remote risk of adverse patient impact or ad13 verse public health impact; or 

14 ‘‘(B) sufficient mitigating measures are 

15 able to be established and applied such that the 

16 in vitro clinical test meets the standard de17 scribed in subparagraph (A). 

18 ‘‘(14) MITIGATING MEASURES.—The term 

19 ‘mitigating measures’— 

20 ‘‘(A) means controls, standards, and other 

21 requirements that the Secretary determines, 

22 based on evidence, are necessary— 

23 ‘‘(i) for an in vitro clinical test, or a 

24 category of in vitro clinical tests, to meet 

25 the applicable standard; or 


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1 ‘‘(ii) to mitigate the risk of harm en2 suing from an undetected inaccurate result 

3 or misinterpretation of a result; and 

4 ‘‘(B) may include, as required by the Sec5 retary, as appropriate, applicable requirements 

6 regarding labeling, conformance to performance 

7 standards and consensus standards, perform8 ance testing, submission of clinical data, adver9 tising, website posting of information, clinical 

10 studies, postmarket surveillance, user com11 prehension studies, training, and confirmatory 

12 laboratory, clinical findings, or testing. 

13 ‘‘(15) MODERATE-RISK.—The term ‘moderate14 risk’, with respect to an in vitro clinical test or cat15 egory of in vitro clinical tests, means that, when 

16 used as intended, such test or category of tests— 

17 ‘‘(A) meets the criteria specified in para18 graph (9) for classification as high-risk, but one 

19 or more mitigating measures are able to be es20 tablished and applied to prevent or detect an in21 accurate result or otherwise sufficiently miti22 gate such risk, but are not sufficient such that 

23 the test is low-risk; or 

24 ‘‘(B)(i) an undetected inaccurate result for 

25 the intended use of the test would cause only 


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1 non-life-threatening harm, harm that is medi2 cally reversible, or the absence, significant 

3 delay, or discontinuation of necessary treatment 

4 that is not life-supporting or life-sustaining; 

5 and 

6 ‘‘(ii) mitigating measures are not able to 

7 be established and applied to prevent or detect 

8 such inaccurate result or otherwise sufficiently 

9 mitigate the risk of such inaccurate result such 

10 that the test would be low-risk. 

11 ‘‘(16) SPECIMEN RECEPTACLE.—The term 

12 ‘specimen receptacle’ means an in vitro clinical test 

13 intended for taking, collecting, holding, storing, or 

14 transporting of specimens derived from the human 

15 body or for in vitro examination for purposes de16 scribed in subparagraph (A) or (B) of section 

17 201(ss)(1). 

18 ‘‘(17) TECHNOLOGY.—The term ‘technology’— 

19 ‘‘(A) means a set of control mechanisms, 

20 energy sources, or operating principles— 

21 ‘‘(i) that do not differ significantly 

22 among multiple in vitro clinical tests; and 

23 ‘‘(ii) for which design and develop24 ment (including analytical and clinical vali25 dation, as applicable) of the tests would be 


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1 addressed in a similar manner or through 

2 similar procedures; and 

3 ‘‘(B) may include clot detection, colori4 metric (non-immunoassay), electrochemical 

5 (non-immunoassay), enzymatic (non6 immunoassay), flow cytometry, fluorometry 

7 (non-immunoassay), immunoassay, mass spec8 trometry or chromatography, microbial culture, 

9 next generation sequencing, nephlometric or 

10 turbidimetric (non-immunoassay), singleplex or 

11 multiplex non-NGS nucleic acid analysis, slide12 based technology, spectroscopy, and any other 

13 technology, as the Secretary determines appro14 priate. 

15 ‘‘(18) TEST.—The term ‘test’, unless otherwise 

16 provided, means an in vitro clinical test. 

17 ‘‘(19) VALID SCIENTIFIC EVIDENCE.—The term 

18 ‘valid scientific evidence’— 

19 ‘‘(A) means, with respect to an in vitro 

20 clinical test, evidence that— 

21 ‘‘(i) has been generated and evaluated 

22 by persons qualified by training or experi23 ence to do so, using procedures generally 

24 accepted by other persons so qualified; and 


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1 ‘‘(ii) forms an appropriate basis for 

2 concluding by qualified experts whether the 

3 applicable standard has been met by the in 

4 vitro clinical test; and 

5 ‘‘(B) may include evidence described in 

6 subparagraph (A) consisting of— 

7 ‘‘(i) peer-reviewed literature; 

8 ‘‘(ii) clinical guidelines; 

9 ‘‘(iii) reports of significant human ex10 perience with an in vitro clinical test; 

11 ‘‘(iv) bench studies; 

12 ‘‘(v) case studies or histories; 

13 ‘‘(vi) clinical data; 

14 ‘‘(vii) consensus standards; 

15 ‘‘(viii) reference standards; 

16 ‘‘(ix) data registries; 

17 ‘‘(x) postmarket data; 

18 ‘‘(xi) real world data; 

19 ‘‘(xii) clinical trials; and 

20 ‘‘(xiii) data collected in countries 

21 other than the United States if such data 

22 are demonstrated to be appropriate for the 

23 purpose of making a regulatory determina24 tion under this subchapter. 


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1 ‘‘SEC. 587A. REGULATION OF IN VITRO CLINICAL TESTS. 

2 ‘‘(a) IN GENERAL.—No person shall introduce or de3 liver for introduction into interstate commerce any in vitro 

4 clinical test, unless— 

5 ‘‘(1) an approval of an application filed pursu6 ant to subsection (a) or (b) of section 587B is effec7 tive with respect to such in vitro clinical test; 

8 ‘‘(2) a technology certification order is in effect 

9 under section 587D; or 

10 ‘‘(3) the test is exempt under sections 587C or 

11 587G from the requirements of section 587B. 

12 ‘‘(b) TRANSFER OR SALE OF IN VITRO CLINICAL

13 TESTS.— 

14 ‘‘(1) TRANSFER AND ASSUMPTION OF REGU15 LATORY OBLIGATIONS.—If ownership of an in vitro 

16 clinical test is sold or transferred in such manner 

17 that the developer transfers the regulatory submis18 sions and obligations applicable under this sub19 chapter with respect to the test, the transferee or 

20 purchaser becomes the developer of the test and 

21 shall have all regulatory obligations applicable to 

22 such a test under this subchapter. The transferee or 

23 purchaser shall update the registration and listing 

24 information under section 587J for the in vitro clin25 ical test. 


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1 ‘‘(2) TRANSFER OR SALE OF PREMARKET AP2 PROVAL.— 

3 ‘‘(A) NOTICE REQUIRED.—If a developer 

4 of an in vitro clinical test transfers or sells the 

5 approval of the in vitro clinical test, the trans6 feror or seller shall— 

7 ‘‘(i) submit a notice of the transfer or 

8 sale to the Secretary and update the reg9 istration and listing information under sec10 tion 587J for the in vitro clinical test; and 

11 ‘‘(ii) submit a supplement to an appli12 cation if required under section 587B(h). 

13 ‘‘(B) EFFECTIVE DATE OF APPROVAL

14 TRANSFER.—A transfer or sale described in 

15 subparagraph (A) shall become effective upon 

16 completion of a transfer or sale described in 

17 paragraph (1) or the approval of a supplement 

18 to an application under section 587B(h) if re19 quired, whichever is later. The transferee or 

20 purchaser shall update the registration and list21 ing information under section 587J for the in 

22 vitro clinical test within 15 calendar days of the 

23 effective date of the transfer or sale. 

24 ‘‘(3) TRANSFER OR SALE OF TECHNOLOGY CER25 TIFICATION.— 


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1 ‘‘(A) REQUIREMENTS FOR TRANSFER OR

2 SALE OF TECHNOLOGY CERTIFICATION.—An 

3 unexpired technology certification can be trans4 ferred or sold if the transferee or purchaser— 

5 ‘‘(i) is an eligible person under section 

6 587D(a)(2); and 

7 ‘‘(ii) maintains, upon such transfer or 

8 sale, test design and quality requirements, 

9 processes and procedures under the scope 

10 of technology certification, and scope of the 

11 technology certification identified in the 

12 applicable technology certification order. 

13 ‘‘(B) NOTICE REQUIRED.—If a developer 

14 of an in vitro clinical test transfers or sells a 

15 technology certification order that has not ex16 pired, the transferor or seller shall submit a no17 tice of the transfer or sale to the Secretary and 

18 shall update the registration and listing infor19 mation under section 587J for all in vitro clin20 ical tests covered by the technology certifi21 cation. 

22 ‘‘(C) EFFECTIVE DATE OF TECHNOLOGY

23 CERTIFICATION TRANSFER.—The transfer of a 

24 technology certification shall become effective 

25 upon completion of a transfer or sale described 


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1 in subparagraph (A). The transferee or pur2 chaser shall update the registration and listing 

3 information under section 587J for the in vitro 

4 clinical test within 30 calendar days of the ef5 fective date of the technology certification 

6 transfer. 

7 ‘‘(D) NEW TECHNOLOGY CERTIFICATION

8 REQUIRED.—If the requirements of subpara9 graph (A)(ii) are not met, the technology cer10 tification order may not be transferred and the 

11 transferee or purchaser of an in vitro clinical 

12 test is required to submit an application for 

13 technology certification and obtain a technology 

14 certification order prior to offering the test for 

15 clinical use. 

16 ‘‘(c) REGULATIONS.—The Secretary may issue regu17 lations to implement this subchapter. 

18 ‘‘SEC. 587B. PREMARKET REVIEW. 

19 ‘‘(a) APPLICATION.— 

20 ‘‘(1) FILING.—Any developer may file with the 

21 Secretary an application for premarket approval of 

22 an in vitro clinical test under this subsection. 

23 ‘‘(2) TRANSPARENCY AND PREDICTABILITY.—If 

24 a developer files a premarket application under this 

25 section and provides any additional documentation 


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1 required under section 587D, the in vitro clinical 

2 test that is the subject of the premarket application 

3 may be utilized as the representative in vitro clinical 

4 test reviewed by the Secretary to support a tech5 nology certification order under section 587D. 

6 ‘‘(3) APPLICATION CONTENT.—An application 

7 submitted under paragraph (1) shall include the fol8 lowing, in such format as the Secretary specifies: 

9 ‘‘(A) General information regarding the in 

10 vitro clinical test, including— 

11 ‘‘(i) the name and address of the ap12 plicant; 

13 ‘‘(ii) the table of contents for the ap14 plication and the identification of the infor15 mation the applicant claims as trade secret 

16 or confidential commercial or financial in17 formation; 

18 ‘‘(iii) a description of the test’s design 

19 and intended use, including the indications 

20 for use; and 

21 ‘‘(iv) a description regarding test 

22 function and performance characteristics. 

23 ‘‘(B) A summary of the data and informa24 tion in the application for the in vitro clinical 

25 test, including— 


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1 ‘‘(i) a brief description of the foreign 

2 and domestic marketing history of the test, 

3 if any, including a list of all countries in 

4 which the test has been marketed and a 

5 list of all countries in which the test has 

6 been withdrawn from marketing for any 

7 reason related to the ability of the in vitro 

8 clinical test to meet the applicable stand9 ard, if known by the applicant; 

10 ‘‘(ii) a description of benefit and risk 

11 considerations related to the in vitro clin12 ical test, including a description of any ap13 plicable adverse effects of the test on 

14 health and how such adverse effects have 

15 been, or will be, mitigated; 

16 ‘‘(iii) a risk assessment of the test; 

17 and 

18 ‘‘(iv) a description of how the data 

19 and information in the application con20 stitute valid scientific evidence and support 

21 a showing that the test meets the applica22 ble standard under section 587(2). 

23 ‘‘(C) The signature of the developer filing 

24 the premarket application or an authorized rep25 resentative. 


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1 ‘‘(D) A bibliography of applicable pub2 lished reports relied upon by the applicant and 

3 a description of any studies conducted, includ4 ing any unpublished studies related to such 

5 test, that are known or that should reasonably 

6 be known to the applicant, and a description of 

7 data and information relevant to the evaluation 

8 of whether the test meets the applicable stand9 ard. 

10 ‘‘(E) Applicable information regarding the 

11 methods used in, and the facilities or controls 

12 used for, the development of the test to dem13 onstrate compliance with the applicable quality 

14 requirements under section 587K. 

15 ‘‘(F) Information demonstrating compli16 ance with any relevant and applicable— 

17 ‘‘(i) mitigating measures under sec18 tion 587E; and 

19 ‘‘(ii) standards established or recog20 nized under section 514 prior to the date 

21 of enactment of the VALID Act of 2022, 

22 or, after applicable standards are estab23 lished or recognized under section 587Q, 

24 with such standards. 


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1 ‘‘(G) Valid scientific evidence to support 

2 that the test meets the applicable standard, 

3 which shall include— 

4 ‘‘(i) summary information for all sup5 porting validation studies performed, in6 cluding a description of the objective of the 

7 study, a description of the experimental de8 sign of the study, a description of any limi9 tations of the study, a brief description of 

10 how the data were collected and analyzed, 

11 a brief description of the results of each 

12 study, and conclusions drawn from each 

13 study; 

14 ‘‘(ii) new raw data for each study, 

15 which may include, as applicable, tabula16 tions of data and results as required under 

17 section 814.20(b)(6)(ii) of title 21, Code of 

18 Federal Regulations (or any successor reg19 ulations); and 

20 ‘‘(iii) for nonclinical laboratory studies 

21 involving the test, if applicable, a state22 ment that studies were conducted in com23 pliance with applicable good laboratory 

24 practices. 


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1 ‘‘(H) To the extent the application seeks 

2 authorization to make modifications to the test 

3 within the scope of the approval that are not 

4 otherwise permitted without premarket review 

5 under this subchapter, a proposed change pro6 tocol that includes validation procedures and 

7 acceptance criteria for anticipated modifications 

8 that could be made to the test within the scope 

9 of the approval. 

10 ‘‘(I) Proposed labeling, in accordance with 

11 the requirements of section 587L. 

12 ‘‘(J) Such other data or information as the 

13 Secretary may require in accordance with the 

14 least burdensome requirements under section 

15 587AA(c). 

16 ‘‘(4) GUIDANCE FOR PREMARKET AND ABBRE17 VIATED PREMARKET APPLICATIONS.—In accordance 

18 with section 825 of the VALID Act of 2022, the 

19 Secretary shall issue draft guidance detailing the in20 formation to be provided in a premarket application 

21 and abbreviated premarket application under this 

22 section. The Secretary shall issue final guidance de23 tailing the information to be provided in a pre24 market application and abbreviated premarket appliVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00165 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 cation under this section not later than 1 year prior 

2 to the effective date of such Act. 

3 ‘‘(5) REFUSE TO FILE A PREMARKET OR AB4 BREVIATED PREMARKET APPLICATION.—The Sec5 retary may refuse to file an application under this 

6 section only for lack of completeness or legibility of 

7 the application. If, after receipt of an application 

8 under this section, the Secretary refuses to file such 

9 an application, the Secretary shall provide to the de10 veloper, within 60 calendar days of receipt of such 

11 application, a description of the reason for such re12 fusal, and identify the information required, if any, 

13 to allow for the filing of the application. 

14 ‘‘(6) SUBSTANTIVE REVIEW FOR DEFICIENT AP15 PLICATION.—If, after receipt of an application under 

16 this section, the Secretary determines that any por17 tion of such application is materially deficient, the 

18 Secretary shall provide to the applicant a description 

19 of such material deficiencies and the information re20 quired to resolve such deficiencies. 

21 ‘‘(7) INSPECTIONS.—With respect to an appli22 cation under paragraph (1), preapproval inspections 

23 authorized by an employee of the Food and Drug 

24 Administration or a person accredited under section 


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1 587Q need not occur unless requested by the Sec2 retary. 

3 ‘‘(b) ABBREVIATED PREMARKET REVIEW.— 

4 ‘‘(1) IN GENERAL.—Any developer may file 

5 with the Secretary an application for abbreviated 

6 premarket approval for— 

7 ‘‘(A) an instrument; 

8 ‘‘(B) a specimen receptacle; 

9 ‘‘(C) an in vitro clinical test that is mod10 erate-risk; or 

11 ‘‘(D) an in vitro clinical test that is deter12 mined by the Secretary to be eligible for abbre13 viated premarket review under section 

14 587F(a)(1)(B). 

15 ‘‘(2) APPLICATION CONTENT.—An application 

16 under paragraph (1) shall include— 

17 ‘‘(A) the information required for applica18 tions submitted under subsection (a)(2), except 

19 that applications under paragraph (1) need not 

20 include— 

21 ‘‘(i) quality requirement information; 

22 or 

23 ‘‘(ii) raw data, unless explicitly re24 quested by the Secretary; and 


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1 ‘‘(B) data, as applicable, to support soft2 ware validation, electromagnetic compatibility, 

3 and electrical safety, and information dem4 onstrating compliance with maintaining quality 

5 systems documentation. 

6 ‘‘(3) SAFETY INFORMATION.—The developer of 

7 an in vitro clinical test specimen receptacle reviewed 

8 under this subsection shall maintain safety informa9 tion for such specimen receptacle. 

10 ‘‘(4) INSPECTIONS.—With respect to an appli11 cation under paragraph (1), preapproval inspections 

12 authorized by an employee of the Food and Drug 

13 Administration or a person accredited under section 

14 587Q need not occur unless requested by the Sec15 retary. 

16 ‘‘(c) INSTRUMENTS AND INSTRUMENT FAMILIES.— 

17 ‘‘(1) IN GENERAL.—A developer of an instru18 ment family shall file with the Secretary an applica19 tion for premarket approval of one version of an in20 strument under this subsection. Any modified 

21 versions of the instrument that generate a new in22 strument within the same instrument family shall be 

23 exempt from premarket review requirements of this 

24 section, provided that the developer of such instru25 ment or instrument family— 


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1 ‘‘(A) maintains documentation that the 

2 new instrument is part of the instrument fam3 ily, as defined in section 587; 

4 ‘‘(B) performs, documents, and maintains 

5 a risk assessment (as described in subsection 

6 (a)(2)(B)(iv)) of the new instrument compared 

7 to the instrument approved under subsection 

8 (b) and no new risks are identified; 

9 ‘‘(C) performs, documents, and maintains 

10 validation and verification activities for the new 

11 instrument; 

12 ‘‘(D) makes such documentation available 

13 to the Secretary upon request; and 

14 ‘‘(E) registers and lists the new instrument 

15 in accordance with section 587J. 

16 ‘‘(2) TEST KITS AND TEST PROTOCOLS.—A test 

17 kit or test protocol that is approved under this sec18 tion for use on an approved instrument or an instru19 ment exempt from premarket review, including an 

20 instrument within an instrument family under this 

21 section, a submission under this section shall not be 

22 required for such test kit or test protocol in order 

23 for it to be used on a new instrument within its in24 strument family, provided that— 


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1 ‘‘(A) use of the test kit or test protocol 

2 with the new instrument does not— 

3 ‘‘(i) change the claims for the test kit 

4 or test protocol, except as applicable, 

5 claims regarding an instrument or instru6 ments that can be used with such test kit 

7 or test protocol; 

8 ‘‘(ii) adversely affect performance of 

9 the test kit or test protocol; or 

10 ‘‘(iii) cause the test kit or test pro11 tocol to no longer conform with perform12 ance standards required under section 

13 587R or comply with any applicable miti14 gating measures under section 587E, con15 ditions of approval under subsection 

16 (e)(2)(B), or restrictions under section 

17 587O; 

18 ‘‘(B) the test developer does not identify 

19 any new risks for the test kit or test protocol 

20 when using the new instrument; 

21 ‘‘(C) the test developer validates the use of 

22 the new instrument with the test kit or test 

23 protocol and maintains validation documenta24 tion; 


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1 ‘‘(D) the test kit or test protocol is not in2 tended for use— 

3 ‘‘(i) at the point of care setting or in 

4 settings for which a certificate of waiver is 

5 in effect under section 353 of the Public 

6 Health Service Act; 

7 ‘‘(ii) without a prescription; 

8 ‘‘(iii) at home; or 

9 ‘‘(iv) in testing donors, donations, and 

10 recipients of blood, blood components, 

11 human cells, tissues, cellular-based prod12 ucts, or tissue-based products; 

13 ‘‘(E) the test developer makes the docu14 mentation described under subparagraph (C) 

15 available to the Secretary upon request; and 

16 ‘‘(F) the test developer updates the listing 

17 information for the test kit or test protocol, as 

18 applicable. 

19 ‘‘(d) AMENDMENTS TO AN APPLICATION.—An appli20 cant shall amend an application submitted under sub21 section (a), (b), or (f) if the applicant becomes aware of 

22 information that could reasonably affect an evaluation 

23 under subsection (e) of whether the approval standard has 

24 been met. 


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1 ‘‘(e) ACTION ON AN APPLICATION FOR PREMARKET

2 APPROVAL.— 

3 ‘‘(1) REVIEW.— 

4 ‘‘(A) DISPOSITION.—As promptly as pos5 sible, but not later than 90 calendar days after 

6 an application under subsection (a) is accepted 

7 for submission (unless the Secretary determines 

8 that an extension is necessary to review one or 

9 more major amendments to the application), or 

10 not later than 60 calendar days after an appli11 cation under subsection (b) is accepted for sub12 mission or a supplemental application under 

13 subsection (f) is accepted for submission, the 

14 Secretary, after considering any applicable re15 port and recommendations pursuant to advisory 

16 committees under section 587H, shall issue an 

17 order approving the application, unless the Sec18 retary finds that the grounds for approval in 

19 paragraph (2) are not met. 

20 ‘‘(B) RELIANCE ON PROPOSED LABEL21 ING.—In determining whether to approve or 

22 deny an application under paragraph (1), the 

23 Secretary shall rely on the indications for use 

24 included in the proposed labeling, provided that 


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1 such labeling is not false or misleading based on 

2 a fair evaluation of all material facts. 

3 ‘‘(2) APPROVAL OF AN APPLICATION.— 

4 ‘‘(A) IN GENERAL.—The Secretary shall 

5 approve an application submitted under sub6 section (a) or (b) with respect to an in vitro 

7 clinical test if the Secretary finds that the ap8 plicable standard is met, and— 

9 ‘‘(i) the applicant is in compliance 

10 with applicable quality requirements in sec11 tion 587K; 

12 ‘‘(ii) the application does not contain 

13 a false statement or misrepresentation of 

14 material fact; 

15 ‘‘(iii) based on a fair evaluation of all 

16 material facts, the proposed labeling is 

17 truthful and non-misleading and complies 

18 with the requirements of section 587L; 

19 ‘‘(iv) the applicant permits, if re20 quested, authorized employees of the Food 

21 and Drug Administration and persons ac22 credited under section 587Q an oppor23 tunity to inspect pursuant to section 704; 

24 ‘‘(v) the test conforms with any appli25 cable performance standards required 


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1 under section 587R and any applicable 

2 mitigating measures under section 587E; 

3 ‘‘(vi) all nonclinical laboratory studies 

4 and clinical investigations involving human 

5 subjects that are described in the applica6 tion were conducted in a manner that 

7 meets the applicable requirements of this 

8 subchapter; and 

9 ‘‘(vii) other data and information the 

10 Secretary may require under subsection 

11 (a)(2)(K) support approval. 

12 ‘‘(B) CONDITIONS OF APPROVAL.—An 

13 order approving an application pursuant to this 

14 section may require reasonable conditions of ap15 proval for the in vitro clinical test, which may 

16 include conformance with applicable mitigating 

17 measures under section 587E, restrictions 

18 under section 587O, and performance standards 

19 under section 587R. 

20 ‘‘(C) PUBLICATION.—The Secretary shall 

21 publish an order for each application approved 

22 pursuant to this paragraph on the public 

23 website of the Food and Drug Administration 

24 and make publicly available a summary of the 

25 data used to approve such application, except to 


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1 the extent the Secretary determines that such 

2 order— 

3 ‘‘(i) contains commercially confidential 

4 or trade secret information; or 

5 ‘‘(ii) if published, would present a risk 

6 to national security. 

7 ‘‘(3) REVIEW OF DENIALS.—An applicant 

8 whose application submitted under this section has 

9 been denied approval under this subsection may, by 

10 petition filed not more than 60 calendar days after 

11 the date on which the applicant receives notice of 

12 such denial, obtain review of the denial in accord13 ance with section 587P. 

14 ‘‘(f) SUPPLEMENTS TO AN APPROVED APPLICA15 TION.— 

16 ‘‘(1) RISK ANALYSIS.—Prior to implementing 

17 any modification to an in vitro clinical test, the hold18 er of the application approved under subsection (a) 

19 or (b) for such test shall perform risk analyses in ac20 cordance with this subsection, unless such modifica21 tion is included in the change protocol submitted by 

22 the applicant and approved under this section or ex23 empt under section 587C. 

24 ‘‘(2) SUPPLEMENT REQUIREMENT.— 


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1 ‘‘(A) IN GENERAL.—If the holder of an ap2 plication of an approved in vitro clinical test 

3 makes a modification to such in vitro clinical 

4 test, except as provided in subparagraph (C), or 

5 otherwise specified by the Secretary, the holder 

6 of the application approved under subsection (e) 

7 for an in vitro clinical test shall submit a sup8 plemental application to the Secretary. The 

9 holder of the application may not implement 

10 such modification to the in vitro clinical test 

11 until such supplemental application is approved. 

12 The information required in a supplemental ap13 plication is limited to what is needed to support 

14 the change. 

15 ‘‘(B) ADJUSTMENTS TO CHANGE PRO16 TOCOL.—The holder of an approved application 

17 may submit under this paragraph a supple18 mental application to modify the change pro19 tocol of the test at any time after the applica20 tion is submitted under subsection (a) or (b). 

21 ‘‘(C) EXCEPTIONS.—Notwithstanding sub22 paragraphs (A) and (B), and so long as the 

23 holder of an approved application submitted 

24 under subsection (a) or (b) for an in vitro clin25 ical test does not add a manufacturing site, or 


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1 change activities at an existing manufacturing 

2 site, with respect to the test, the holder of an 

3 approved application may, without submission 

4 of a supplemental application, implement the 

5 following modifications to the test: 

6 ‘‘(i) Modifications in accordance with 

7 an approved change protocol under sub8 section (a)(3)(H). 

9 ‘‘(ii) Modifications that are exempt 

10 under section 587C(b). 

11 ‘‘(iii) Labeling changes that are ap12 propriate to address a safety concern, ex13 cept such labeling changes that include any 

14 of the following, remain subject to sub15 paragraph (A): 

16 ‘‘(I) A change to the indications 

17 for use of the test. 

18 ‘‘(II) A change to the perform19 ance claims made with respect to the 

20 test. 

21 ‘‘(III) A change that adversely 

22 affects performance of the test. 

23 ‘‘(D) REPORTING FOR CERTAIN MODIFICA24 TIONS MADE PURSUANT TO A CHANGE PRO25 TOCOL.—The holder of an application approved 


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1 under subsection (e), with an approved change 

2 protocol under subsection (a)(2)(H) for such in 

3 vitro clinical test shall— 

4 ‘‘(i) report any modification to such 

5 test made pursuant to such change pro6 tocol approved under subsection (a)(2)(H) 

7 in a submission under section 

8 587J(c)(2)(B); and 

9 ‘‘(ii) include in such report— 

10 ‘‘(I) a description of the modi11 fication; 

12 ‘‘(II) the rationale for imple13 menting such modification; and 

14 ‘‘(III) as applicable, a summary 

15 of the evidence supporting that the 

16 test, as modified, meets the applicable 

17 standard, complies with performance 

18 standards required under section 

19 587Q, and complies with any miti20 gating measures established under 

21 section 587E and any restrictions 

22 under section 587O. 

23 ‘‘(E) REPORTING FOR CERTAIN SAFETY

24 RELATED LABELING CHANGES.—The holder of 

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1 proved under subsection (a) or (b) pursuant to 

2 subsection (e) shall— 

3 ‘‘(i) report to the Secretary any modi4 fication to the test described in subpara5 graph (C)(iii) not more than 30 days after 

6 the date on which the test, with the modi7 fications, is introduced into interstate com8 merce; and 

9 ‘‘(ii) include in the report— 

10 ‘‘(I) a description of the change 

11 or changes; 

12 ‘‘(II) the rationale for imple13 menting such change or changes; and 

14 ‘‘(III) a description of how the 

15 change or changes were evaluated. 

16 ‘‘(3) CONTENTS OF SUPPLEMENT.—Unless oth17 erwise specified by the Secretary, a supplement 

18 under this subsection shall include— 

19 ‘‘(A) for modifications other than manufac20 turing site changes requiring a supplement— 

21 ‘‘(i) a description of the modification; 

22 ‘‘(ii) data relevant to the modification 

23 to demonstrate that the applicable stand24 ard is met, not to exceed data require25 ments for the original submission; 


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1 ‘‘(iii) acceptance criteria; and 

2 ‘‘(iv) any revised labeling; and 

3 ‘‘(B) for manufacturing site changes— 

4 ‘‘(i) the information listed in subpara5 graph (A); and 

6 ‘‘(ii) information regarding the meth7 ods used in, or the facilities or controls 

8 used for, the development of the test to 

9 demonstrate compliance with the applicable 

10 quality requirements under section 587K. 

11 ‘‘(4) ADDITIONAL DATA.—The Secretary may 

12 require, when necessary, data to evaluate a modifica13 tion to an in vitro clinical test that is in addition to 

14 the data otherwise required under the preceding 

15 paragraphs if the data request is in accordance with 

16 the least burdensome requirements under section 

17 587AA(c). 

18 ‘‘(5) CONDITIONS OF APPROVAL.—In an order 

19 approving a supplement under this subsection, the 

20 Secretary may require conditions of approval for the 

21 in vitro clinical test, including compliance with re22 strictions under section 587O and conformance to 

23 performance standards under section 587R. 

24 ‘‘(6) APPROVAL.—The Secretary shall approve 

25 a supplement under this subsection if— 


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1 ‘‘(A) the data demonstrate that the modi2 fied in vitro clinical test meets the applicable 

3 standard; and 

4 ‘‘(B) the holder of the application approved 

5 under subsection (e) for the test has dem6 onstrated compliance with applicable quality 

7 and inspection requirements, as applicable and 

8 appropriate. 

9 ‘‘(7) PUBLICATION.—The Secretary shall pub10 lish on the public website of the Food and Drug Ad11 ministration notice of any order approving a supple12 ment under this subsection, except that such publi13 cation shall exclude— 

14 ‘‘(A) commercial confidential or trade se15 cret information; and 

16 ‘‘(B) any other information that the Sec17 retary determines to relate to national security 

18 or countermeasures or to be restricted from dis19 closure pursuant to another provision of law. 

20 ‘‘(8) REVIEW OF DENIAL.—An applicant whose 

21 supplement under this subsection has been denied 

22 approval may, by petition filed on or before the 60th 

23 calendar day after the date upon which the applicant 

24 receives notice of such denial, obtain review of the 

25 denial in accordance with section 587P. 


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1 ‘‘(g) WITHDRAWAL AND TEMPORARY SUSPENSION

2 OF APPROVAL.— 

3 ‘‘(1) ORDER WITHDRAWING APPROVAL.— 

4 ‘‘(A) IN GENERAL.—The Secretary may, 

5 after providing due notice and an opportunity 

6 for an informal hearing to the holder of an ap7 proved application for an in vitro clinical test 

8 under this section, issue an order withdrawing 

9 approval of the application if the Secretary 

10 finds that— 

11 ‘‘(i) the grounds for approval under 

12 subsection (e) are no longer met; 

13 ‘‘(ii) there is a reasonable likelihood 

14 that the test would cause death or serious 

15 adverse health consequences, including by 

16 causing the absence, significant delay, or 

17 discontinuation of life-saving or life sus18 taining medical treatment; 

19 ‘‘(iii) the holder of the approved appli20 cation— 

21 ‘‘(I) has failed to, or repeatedly 

22 or deliberately failed to, maintain 

23 records to make reports, as required 

24 under section 587M; 


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1 ‘‘(II) has refused to permit ac2 cess to, or copying or verification of 

3 such records, as required under sec4 tion 704; 

5 ‘‘(III) has not complied with the 

6 requirements of section 587K; or 

7 ‘‘(IV) has not complied with any 

8 mitigating measure required under 

9 section 587E or restriction under sec10 tion 587O; or 

11 ‘‘(iv) the labeling of such in vitro clin12 ical test, based on a fair evaluation of all 

13 material facts, is false or misleading in any 

14 particular and was not corrected within a 

15 reasonable time after receipt of written no16 tice from the Secretary of such fact. 

17 ‘‘(B) CONTENT.—An order under subpara18 graph (A) withdrawing approval of an applica19 tion shall state each ground for withdrawal and 

20 shall notify the holder of such application 60 

21 calendar days prior to issuing such order. 

22 ‘‘(C) PUBLICATION.—The Secretary shall 

23 publish any order under subparagraph (A) on 

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1 ministration, except that such publication shall 

2 exclude— 

3 ‘‘(i) commercial confidential or trade 

4 secret information; and 

5 ‘‘(ii) any other information that the 

6 Secretary determines, if published, would 

7 present a risk to national security. 

8 ‘‘(2) ORDER OF TEMPORARY SUSPENSION.—If, 

9 after providing due notice and an opportunity for an 

10 informal hearing to the holder of an approved appli11 cation for an in vitro clinical test under this section, 

12 the Secretary determines, based on scientific evi13 dence, that there is a reasonable likelihood that the 

14 in vitro clinical test would cause death or serious ad15 verse health consequences, such as by causing the 

16 absence, significant delay, or discontinuation of life17 saving or life-sustaining medical treatment, the Sec18 retary shall, by order, temporarily suspend the ap19 proval of the application. If the Secretary issues 

20 such an order, the Secretary shall proceed expedi21 tiously under paragraph (1) to withdraw approval of 

22 such application. 

23 ‘‘(3) APPEAL WITHDRAWING APPROVAL AND

24 ORDERS OF TEMPORARY SUSPENSIONS.—An order of 


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1 withdrawal or an order of temporary suspension may 

2 be appealed under 587P. 

3 ‘‘SEC. 587C. EXEMPTIONS. 

4 ‘‘(a) IN GENERAL.—The following in vitro clinical 

5 tests are exempt from premarket review under section 

6 587B, and may be lawfully marketed subject to other ap7 plicable requirements of this Act: 

8 ‘‘(1) TESTS EXEMPT FROM SECTION 510(k).— 

9 ‘‘(A) EXEMPTION.—An in vitro clinical 

10 test is exempt from premarket review under 

11 section 587B and may be lawfully marketed 

12 subject to the other applicable requirements of 

13 this Act, if the developer of the in vitro clinical 

14 test— 

15 ‘‘(i) maintains documentation dem16 onstrating that the test meets and con17 tinues to meet the criteria set forth in sub18 paragraph (B); and 

19 ‘‘(ii) makes such documentation avail20 able to the Secretary upon request. 

21 ‘‘(B) CRITERIA FOR EXEMPTION.—An in 

22 vitro clinical test is exempt as specified in sub23 paragraph (A) if such test— 


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1 ‘‘(i)(I) was offered for clinical use 

2 prior to the date of enactment of the 

3 VALID Act of 2022; 

4 ‘‘(II) immediately prior to such date 

5 of enactment was exempt pursuant to sub6 section (l) or (m)(2) of section 510 from 

7 the requirements for submission of a re8 port under section 510(k); or 

9 ‘‘(III)(aa) was not offered for clinical 

10 use prior to such date of enactment; 

11 ‘‘(bb) is not an instrument; and 

12 ‘‘(cc) falls within a category of tests 

13 that was exempt from the requirements for 

14 submission of a report under section 

15 510(k) as of such date of enactment (in16 cluding class II devices and excluding class 

17 I devices described in section 510(l)); 

18 ‘‘(ii) meets the applicable standard as 

19 described in section 587(2); 

20 ‘‘(iii) is not offered with labeling and 

21 advertising that is false or misleading; and 

22 ‘‘(iv) is not likely to cause or con23 tribute to serious adverse health con24 sequences. 


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1 ‘‘(C) EFFECT ON SPECIAL CONTROLS.— 

2 For any in vitro clinical test, or category of in 

3 vitro clinical tests, that is exempt from pre4 market review based on the criteria in subpara5 graph (B), any special control that applied to a 

6 device within a predecessor category imme7 diately prior to the date of enactment of the 

8 VALID Act of 2022 shall be deemed a miti9 gating measure applicable under section 587E 

10 to an in vitro clinical test within the successor 

11 category, except to the extent such mitigating 

12 measure is withdrawn or changed in accordance 

13 with section 587E. 

14 ‘‘(D) NEAR-PATIENT TESTING.—Not later 

15 than 1 year after the date of enactment of the 

16 VALID Act of 2022, the Secretary shall issue 

17 draft guidance indicating categories of tests 

18 that shall be exempt from premarket review 

19 under section 587B when offered for near-pa20 tient testing (point of care), which were not ex21 empt from submission of a report under section 

22 510(k) pursuant to subsection (l) or (m)(2) of 

23 section 510 and regulations imposing limita24 tions on exemption for in vitro devices intended 

25 for near-patient testing (point of care). 


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1 ‘‘(2) LOW-RISK TESTS.— 

2 ‘‘(A) EXEMPTION.—An in vitro clinical 

3 test is exempt from premarket review under 

4 section 587B and may be lawfully marketed 

5 subject to the other applicable requirements of 

6 this Act, including section 587J(b)(6), if such 

7 test meets the definition of low-risk under sec8 tion 587 and if the developer of the test— 

9 ‘‘(i) maintains documentation dem10 onstrating that the in vitro clinical test 

11 meets and continues to meet the criteria 

12 set forth in paragraph (2); and 

13 ‘‘(ii) makes such documentation avail14 able to the Secretary upon request. 

15 ‘‘(B) CRITERIA FOR EXEMPTION.—An in 

16 vitro clinical test is exempt as specified in sub17 paragraph (A) if— 

18 ‘‘(i) the in vitro clinical test meets the 

19 applicable standard as described in 587(2); 

20 ‘‘(ii) the labeling and advertising are 

21 not false or misleading; 

22 ‘‘(iii) the in vitro clinical test is not 

23 likely to cause or contribute to serious ad24 verse health consequences; and 


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1 ‘‘(iv) the in vitro clinical test is listed 

2 pursuant to section 587J or falls within a 

3 category of tests listed as described in sub4 paragraph (C). 

5 ‘‘(C) LIST OF LOW-RISK TESTS.— 

6 ‘‘(i) IN GENERAL.—The Secretary 

7 shall maintain, and make publicly available 

8 on the website of the Food and Drug Ad9 ministration, a list of in vitro clinical tests, 

10 and categories of in vitro clinical tests, 

11 that are low-risk in vitro clinical tests for 

12 purposes of the exemption under this para13 graph. 

14 ‘‘(ii) INCLUSION.—The list under 

15 clause (i) shall consist of— 

16 ‘‘(I) all in vitro clinical tests and 

17 categories of in vitro clinical tests that 

18 are exempt from premarket review 

19 pursuant to subsection (d)(1) or 

20 (d)(3); and 

21 ‘‘(II) all in vitro clinical tests and 

22 categories of in vitro clinical tests that 

23 are designated by the Secretary pur24 suant to subparagraph (C) as low-risk 

25 for purposes of this paragraph. 


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1 ‘‘(D) DESIGNATION OF TESTS AND CAT2 EGORIES.—Without regard to subchapter II of 

3 chapter 5 of title 5, United States Code, the 

4 Secretary may designate, in addition to the 

5 tests and categories described in subparagraph 

6 (C)(i), additional in vitro clinical tests, and cat7 egories of in vitro clinical tests, as low-risk in 

8 vitro clinical tests for purposes of the exemption 

9 under this paragraph. The Secretary may make 

10 such a designation on the Secretary’s own ini11 tiative or in response to a request by a devel12 oper pursuant to subsection (a) or (b) of section 

13 587F. In making such a designation for a test 

14 or category of tests, the Secretary shall con15 sider— 

16 ‘‘(i) whether the test, or category of 

17 tests, is low-risk; 

18 ‘‘(ii) the existence of and ability to de19 velop mitigating measures sufficient for 

20 such test category to meet the low-risk 

21 standard; and 

22 ‘‘(iii) such other factors as the Sec23 retary determines to be appropriate for the 

24 protection of the public health. 

25 ‘‘(3) HUMANITARIAN TEST EXEMPTION.— 


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1 ‘‘(A) IN GENERAL.—An in vitro clinical 

2 test that meets the criteria under subparagraph 

3 (B) is exempt from premarket review under sec4 tion 587B and may be lawfully offered subject 

5 to the other applicable requirements of this sub6 chapter, if the developer of the test— 

7 ‘‘(i) maintains documentation (which 

8 may include literature citations in special9 ized medical journals, textbooks, special10 ized medical society proceedings, and gov11 ernmental statistics publications, or, if no 

12 such studies or literature citations exist, 

13 credible conclusions from appropriate re14 search or surveys) demonstrating that such 

15 test meets and continues to meet the cri16 teria described in this subsection; and 

17 ‘‘(ii) makes such documentation avail18 able to the Secretary upon request. 

19 ‘‘(B) CRITERIA FOR EXEMPTION.—An in 

20 vitro clinical test is exempt as described in sub21 paragraph (A) if— 

22 ‘‘(i) the in vitro clinical test is in23 tended by the developer for use for a diag24 nostic purpose for a disease or condition 

25 that affects not more than 10,000 (or such 


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1 other higher number determined by the 

2 Secretary) individuals in the United States 

3 per year; and 

4 ‘‘(ii) the in vitro clinical test meets 

5 the applicable standard described in sec6 tion 587(2); 

7 ‘‘(iii) the labeling and advertising for 

8 the in vitro clinical test are not false or 

9 misleading; 

10 ‘‘(iv) the in vitro clinical test is not 

11 likely to cause or contribute to serious 

12 health consequences; and 

13 ‘‘(v) the in vitro clinical test is not in14 tended for screening. 

15 ‘‘(C) EXCEPTION FOR CERTAIN TESTS.— 

16 An in vitro clinical test intended to inform the 

17 use of a specific individual or specific type of bi18 ological product, drug, or device shall be eligible 

19 for an exemption from premarket review under 

20 this subsection only if, the developer submits a 

21 request under subsection (m) for informal feed22 back and the Secretary determines that such in 

23 vitro clinical test is eligible for an exemption 

24 from premarket review under this subsection. 


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1 ‘‘(4) CUSTOM TESTS AND LOW-VOLUME

2 TESTS.—An in vitro clinical test is exempt from pre3 market review under section 587B, quality require4 ments under section 587K, and listing requirements 

5 under section 587J, and may be lawfully marketed 

6 subject to the other applicable requirements of this 

7 Act, if— 

8 ‘‘(A) such in vitro clinical test— 

9 ‘‘(i) is a test protocol performed for 

10 not more than 5 patients per year (or such 

11 other higher number determined by the 

12 Secretary), in a laboratory certified by the 

13 Secretary under section 353 of the Public 

14 Health Service Act that— 

15 ‘‘(I) meets the requirements to 

16 perform tests of high-complexity in 

17 which the test protocol was developed; 

18 or 

19 ‘‘(II) meets the requirements to 

20 perform tests of high-complexity with21 in the same corporate organization 

22 and having common ownership by the 

23 same parent corporation as the lab24 oratory in which such test protocol 

25 was developed; or 


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1 ‘‘(ii) is an in vitro clinical test devel2 oped or modified to diagnose a unique pa3 thology or physical condition of a specific 

4 patient or patients, upon order of a health 

5 professional or other specially qualified 

6 person designated under regulations, for 

7 which no other in vitro clinical test is com8 mercially available in the United States, 

9 and is— 

10 ‘‘(I) not intended for use with re11 spect to more than 5 (or such other 

12 higher number determined by the Sec13 retary) other patients; and 

14 ‘‘(II) after the development of 

15 such test, not included in any test 

16 menu or template test report or other 

17 promotional materials, and is not oth18 erwise advertised; and 

19 ‘‘(B) the developer of the in vitro clinical 

20 test— 

21 ‘‘(i) maintains documentation dem22 onstrating that such test meets the appli23 cable criteria described in subparagraph 

24 (A); 


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1 ‘‘(ii) makes such documentation, such 

2 as a prescription order requesting the cus3 tom test for an individual patient, available 

4 to the Secretary upon request; and 

5 ‘‘(iii) informs the Secretary, on an an6 nual basis, in a manner prescribed by the 

7 Secretary by guidance, that such test was 

8 offered. 

9 ‘‘(5) IN VITRO CLINICAL TESTS UNDER A TECH10 NOLOGY CERTIFICATION ORDER.—An in vitro clin11 ical test that is within the scope of a technology cer12 tification order, as described in section 587D(a), is 

13 exempt from premarket review under section 

14 587B.’’. 

15 ‘‘(6) MODIFIED TESTS.— 

16 ‘‘(A) IN GENERAL.—An in vitro clinical 

17 test that is modified is exempt from premarket 

18 review under section 587B if— 

19 ‘‘(i)(I) the modification is made by— 

20 ‘‘(aa) the developer that obtained 

21 premarket approval for the unmodi22 fied version of the test under section 

23 587B; or 

24 ‘‘(bb) a clinical laboratory cer25 tified by the Secretary under section 


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1 353 of the Public Health Service Act 

2 that meets the requirements for per3 forming high complexity testing, to a 

4 lawfully offered in vitro clinical test, 

5 including another developer’s lawfully 

6 offered in vitro clinical test, excluding 

7 investigational in vitro clinical tests 

8 offered under section 587S, and the 

9 modified test is performed— 

10 ‘‘(AA) in the same clinical 

11 laboratory in which it was devel12 oped for which a certification is 

13 still in effect under section 353 

14 that meets the requirements to 

15 perform tests of high complexity; 

16 ‘‘(BB) by another clinical 

17 laboratory for which a certificate 

18 is in effect under section 353 

19 that meets the requirements to 

20 perform tests of high complexity, 

21 is within the same corporate or22 ganization, and has common 

23 ownership by the same parent 

24 corporation as the laboratory in 

25 which the test was developed; or 


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1 ‘‘(CC) by a clinical labora2 tory for which a certificate is in 

3 effect under section 353 that 

4 meets the requirements to per5 form tests of high complexity and 

6 is within a public health labora7 tory network coordinated [or 

8 managed] by the Centers for Dis9 ease Control and Prevention, if 

10 the test was developed by the 

11 Centers for Disease Control and 

12 Prevention or another laboratory 

13 within such public health labora14 tory network; or 

15 ‘‘(II) the modification does not— 

16 ‘‘(aa) constitute a significant 

17 change to the indications for use; 

18 ‘‘(bb) cause the test to no longer 

19 comply with applicable mitigating 

20 measures under section 587E or re21 strictions under section 587O; 

22 ‘‘(cc) significantly change per23 formance claims or significantly and 

24 adversely change performance, unless 

25 provided for under an approved 


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1 change protocol under section 

2 587(a)(2)(H); or 

3 ‘‘(dd) constitute an adverse 

4 change in the safety of the in vitro 

5 clinical test for individuals who come 

6 in contact with the in vitro clinical 

7 test; 

8 ‘‘(ii) the test meets the applicable 

9 standard as described in section 587(2); 

10 ‘‘(iii) the labeling and advertising are 

11 not false or misleading; and 

12 ‘‘(iv) the test is not likely to cause or 

13 contribute to serious adverse health con14 sequences. 

15 ‘‘(B) CERTAIN MODIFICATIONS.—A modi16 fication to extend specimen stability is exempt 

17 from premarket review under section 587B if 

18 the modified test meets the requirements in 

19 clauses (iii) through (v) of subparagraph (A). 

20 ‘‘(C) MODIFICATIONS UNDER A CHANGE

21 PROTOCOL.—Notwithstanding subparagraph 

22 (A), a modification made under a change pro23 tocol pursuant to subsection (a)(2)(H) of sec24 tion 587B is exempt from review under such 

25 section. 


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1 ‘‘(D) DOCUMENTATION.—A person who 

2 modifies an in vitro clinical test in a manner 

3 that is a modification described in subpara4 graph (A) shall— 

5 ‘‘(i) document the modification that 

6 was made and the basis for determining 

7 that the modification, considering the 

8 changes individually and collectively, is a 

9 type of modification described in subpara10 graph (A), (B), or (C); and 

11 ‘‘(ii) provide such documentation to 

12 the Secretary upon request or inspection. 

13 ‘‘(E) GUIDANCE.—Not later than 30 

14 months after the date of enactment of the 

15 VALID Act of 2022, the Secretary shall issue 

16 guidance regarding the in vitro clinical tests 

17 that are modified and exempt from premarket 

18 review under section 587B pursuant to this 

19 paragraph. 

20 ‘‘(b) MANUAL TESTS.— 

21 ‘‘(1) EXEMPTION.—An in vitro clinical test is 

22 exempt from all requirements of this subchapter if 

23 the output of such in vitro clinical test is the result 

24 of direct, manual observation, without the use of 

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1 mediate or final interpretation, by a qualified labora2 tory professional, and such in vitro clinical test— 

3 ‘‘(A) is designed, developed, and used with4 in a single clinical laboratory for which a cer5 tificate is in effect under section 353 of the 

6 Public Health Service Act that meets the re7 quirements under section 353 for performing 

8 high-complexity testing; 

9 ‘‘(B) is not a specimen receptacle, instru10 ment, or an in vitro clinical test that includes 

11 an instrument or specimen receptacle that is 

12 not approved under or exempt from section 

13 587B; 

14 ‘‘(C) is not a high-risk test, or is a high15 risk test that the Secretary has determined 

16 meets at least one condition in paragraph (2) 

17 and is otherwise appropriate for this exemption; 

18 and 

19 ‘‘(D) is not intended for testing donors, 

20 donations, or recipients of blood, blood compo21 nents, human cells, tissues, cellular-based prod22 ucts, or tissue-based products. 

23 ‘‘(2) HIGH-RISK TEST LIMITATION OR CONDI24 TION.—A high-risk test may be exempt under paraVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00200 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 graph (1) from the requirements of this subchapter 

2 only if— 

3 ‘‘(A) no component or part of such test, in4 cluding any reagent, is introduced into inter5 state commerce under the exemption under 

6 paragraph (5), and any article for taking or de7 riving specimens from the human body used in 

8 conjunction with the test remains subject to the 

9 requirements of this subchapter; or 

10 ‘‘(B) the test has been developed in accord11 ance with the applicable test design and quality 

12 requirements under section 587J. 

13 ‘‘(c) PUBLIC HEALTH SURVEILLANCE ACTIVITIES.— 

14 ‘‘(1) IN GENERAL.—The provisions of this sub15 chapter shall not apply to a test intended by the de16 veloper to be used solely for public health surveil17 lance activities. 

18 ‘‘(2) EXCLUSION.—An in vitro clinical test used 

19 for public health surveillance activities is not ex20 cluded from the provisions of this subchapter pursu21 ant to this subsection if such test is intended for use 

22 in making clinical decisions for individual patients. 

23 ‘‘(d) GENERAL LABORATORY EQUIPMENT.—Any in24 strument that does not produce an analytical result, and 

25 that functions as a component of pre-analytical procedures 


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1 related to in vitro clinical tests, is not subject to the re2 quirements of this subchapter, provided that the instru3 ment is operating in a clinical laboratory that is certified 

4 under section 353 of the Public Health Service Act. 

5 ‘‘(e) COMPONENTS AND PARTS.— 

6 ‘‘(1) IN GENERAL.—Subject to paragraph (2), a 

7 component or part described in section 

8 201(ss)(2)(E) is— 

9 ‘‘(A) exempt from the requirements of this 

10 subchapter if it is intended for further develop11 ment as described in paragraph (3); or 

12 ‘‘(B) subject to the requirements of this 

13 subchapter and regulated based on its risk 

14 when used as intended by the developer, not15 withstanding its subsequent use by a developer 

16 as a component, part, or raw material of an17 other in vitro clinical test. 

18 ‘‘(2) INAPPLICABILITY TO OTHER TESTS.—Not19 withstanding paragraph (1), an in vitro clinical test 

20 that is described in section 201(ss)(1)(B) and that 

21 uses a component or part described in such subpara22 graph shall be subject to the requirements of this 

23 subchapter, unless the test is otherwise exempt 

24 under this section. 


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1 ‘‘(3) FURTHER DEVELOPMENT.—A component, 

2 part, or raw material (as described in paragraph 

3 (1)) is intended for further development (for pur4 poses of such paragraph) if— 

5 ‘‘(A) it is intended solely for use in the de6 velopment of another in vitro clinical test; and 

7 ‘‘(B) in the case of such a test that is in8 troduced or delivered for introduction into 

9 interstate commerce after the date of enactment 

10 of the VALID Act of 2022, the labeling of such 

11 test bears the following statement: ‘This prod12 uct is intended solely for further development of 

13 an in vitro clinical test and is exempt from 

14 FDA regulation. This product must be evalu15 ated by the in vitro clinical test developer if it 

16 is used with or in the development of an in vitro 

17 clinical test.’. 

18 ‘‘(f) GENERAL EXEMPTION AUTHORITY.—The Sec19 retary may, by order published in the Federal Register 

20 following notice and an opportunity for comment, exempt 

21 a class of persons from any section under this subchapter 

22 upon a finding that such exemption is appropriate for the 

23 protection of the public health and other relevant consider24 ations. 


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1 ‘‘(g) EXEMPTION.—An in vitro clinical test that is in2 tended solely for use in forensic analysis or law enforce3 ment activity is exempt from the requirements of this sub4 chapter. An in vitro clinical test that is intended for use 

5 in making clinical decisions for individual patients, or 

6 whose individually identifiable results may be reported 

7 back to an individual patient or the patient’s health care 

8 provider, even if also intended for forensic analysis or law 

9 enforcement purposes, is not intended solely for forensic 

10 analysis or law enforcement for purposes of this sub11 section. 

12 ‘‘(h) REVOCATION.— 

13 ‘‘(1) IN GENERAL.—The Secretary may revoke 

14 any exemption with respect to in vitro clinical tests 

15 with the same indications for use if new clinical in16 formation indicates that the exemption of an in vitro 

17 clinical test or tests from premarket review under 

18 section 587B has a reasonable probability of severe 

19 adverse health consequences, including the absence, 

20 delay, or discontinuation of appropriate medical 

21 treatment. 

22 ‘‘(2) PROCESS.—Any action under paragraph 

23 (1) shall be made by publication of a notice of such 

24 proposed action on the website of the Food and 

25 Drug Administration, the consideration of comments 


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1 to a public docket on such proposal, and publication 

2 of a final action on such website within 60 calendar 

3 days of the close of the comment period posted to 

4 such public docket, notwithstanding subchapter II of 

5 chapter 5 of title 5, United States Code. 

6 ‘‘(i) PRE-ANALYTICAL INSTRUMENT.—A pre-analyt7 ical instrument is exempt from premarket review under 

8 section 587B and may be lawfully offered subject to the 

9 other applicable requirements of this Act, if either of the 

10 following applies: 

11 ‘‘(1) Such instrument provides additional infor12 mation regarding the sample or performs an action 

13 on the sample but is not preparing or processing the 

14 sample and does not perform any function of an an15 alytical instrument. Such types of pre-analytical in16 struments include barcode readers, sample movers, 

17 and sample identifiers. 

18 ‘‘(2) Such instrument processes or prepares the 

19 sample prior to use on an analytical instrument, 

20 does not perform any function of an analytical in21 strument, and does not select, isolate, or prepare a 

22 part of a sample based on specific properties. Such 

23 types of pre-analytical instruments may include sam24 ple mixers, DNA extractors and those used to dilute 

25 samples. 


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1 ‘‘SEC. 587D. TECHNOLOGY CERTIFICATION. 

2 ‘‘(a) DEFINITIONS.—In this section: 

3 ‘‘(1) ELIGIBLE IN VITRO CLINICAL TEST.—The 

4 term ‘eligible in vitro clinical test’ means an in vitro 

5 clinical test that is not— 

6 ‘‘(A) a component or part of an in vitro 

7 clinical test as described in section 

8 201(ss)(2)(E); 

9 ‘‘(B) an instrument under section 

10 201(ss)(2)(B) or an in vitro clinical test that 

11 includes an instrument that is not approved 

12 under, or exempt from, section 587B; 

13 ‘‘(C) a specimen receptacle under section 

14 201(ss)(2)(C) or an in vitro clinical test that in15 cludes a specimen receptacle that is not ap16 proved under, or exempt from, section 587B; 

17 ‘‘(D) an in vitro clinical test, including re18 agents used in such tests, intended for use for 

19 testing donors, donations, and recipients of 

20 blood, blood components, human cells, tissues, 

21 cellular-based products, or tissue-based prod22 ucts; 

23 ‘‘(E) high-risk; 

24 ‘‘(F) a combination product unless such 

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1 nology certification order pursuant to the regu2 latory pathway designation process described in 

3 section 587F, or as described in subsection (k); 

4 or 

5 ‘‘(G) a first-of-a-kind in vitro clinical test, 

6 unless such test has been determined to be eli7 gible to be introduced into interstate commerce 

8 under a technology certification order pursuant 

9 to the regulatory pathway designation process 

10 described in section 587F, or as described in 

11 subsection (k). 

12 ‘‘(2) ELIGIBLE PERSON.—The term ‘eligible 

13 person’ means an in vitro clinical test developer un14 less such developer— 

15 ‘‘(A) is a laboratory subject to section 353 

16 of the Public Health Service Act and does not 

17 have in effect a certificate applicable to the cat18 egory of laboratory examination or other proce19 dure; 

20 ‘‘(B) was a laboratory, or an owner or op21 erator or any employee of a laboratory, found 

22 to have committed a significant violation of sec23 tion 353 of the Public Health Service Act that 

24 resulted in a suspended, revoked, or limited cer25 tificate within the 2-year period preceding the 


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1 date of the submission of the application for a 

2 technology certificate under subsection (c) and 

3 such violation has not been resolved; or 

4 ‘‘(C) has been found to have submitted in5 formation to the Secretary, or otherwise dis6 seminated information, that— 

7 ‘‘(i) made false or misleading state8 ments relevant to the requirements of this 

9 subchapter; or 

10 ‘‘(ii) violated any requirement of this 

11 Act, where such violation exposed individ12 uals to serious risk of illness, injury, or 

13 death, unless— 

14 ‘‘(I) such violation has been re15 solved; or 

16 ‘‘(II) such violation is not perti17 nent to any in vitro clinical test within 

18 the scope of the technology certifi19 cation that such developer seeks. 

20 ‘‘(b) APPLICABILITY.— 

21 ‘‘(1) IN GENERAL.—An in vitro clinical test is 

22 not subject to section 587B and may be introduced 

23 into interstate commerce if the in vitro clinical 

24 test— 

25 ‘‘(A) is an eligible in vitro clinical test; 


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1 ‘‘(B) is developed by an eligible person; 

2 ‘‘(C) falls within the scope of a technology 

3 certification order issued under this section and 

4 that is in effect; 

5 ‘‘(D) complies with the conditions of the 

6 technology certification order, including with 

7 applicable mitigating measures under section 

8 587E, restrictions under section 587O, and per9 formance standards under section 587R; and 

10 ‘‘(E) meets the applicable standard de11 scribed in section 587(2). 

12 ‘‘(2) SCOPE.— 

13 ‘‘(A) IN GENERAL.—Subject to subpara14 graph (B), the scope of a technology certifi15 cation order issued under this section shall 

16 apply to multiple in vitro clinical tests utilizing 

17 the technology do not significantly differ in con18 trol mechanisms, energy sources, or operating 

19 principles and for which development, including 

20 design, and analytical and clinical validation, of 

21 the in vitro clinical tests would be addressed 

22 through similar procedures, and be no broader 

23 than— 

24 ‘‘(i) a single technology type; or 


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1 ‘‘(ii) a fixed combination of tech2 nologies. 

3 ‘‘(B) TECHNOLOGY TYPE.—A technology 

4 type described in this paragraph may include 

5 clot detection, colorimetric (non-immunoassay), 

6 electrochemical (non-immunoassay), enzymatic 

7 (non-immunoassay), flow cytometry, 

8 fluorometry (non-immunoassay), immunoassay, 

9 mass spectrometry or chromatography, micro10 bial culture, next generation sequencing, 

11 nephlometric or turbidimetric (non12 immunoassay), singleplex or multiplex non-NGS 

13 nucleic acid analysis, slide-based technology, 

14 spectroscopy, and any other technology, as the 

15 Secretary determines appropriate. 

16 ‘‘(c) APPLICATION FOR TECHNOLOGY CERTIFI17 CATION.— 

18 ‘‘(1) IN GENERAL.—A developer seeking a tech19 nology certification order shall submit an application 

20 under this subsection, which shall contain the infor21 mation specified under paragraph (2). 

22 ‘‘(2) CONTENT OF APPLICATION.—A developer 

23 that submits an application for a technology certifi24 cation shall include all necessary information to 

25 make a showing that all eligible in vitro clinical tests 


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1 developed within the scope of the technology certifi2 cation order will meet the applicable standard, in3 cluding— 

4 ‘‘(A) the name and address of the devel5 oper; 

6 ‘‘(B) a table of contents for the application 

7 and the identification of the information the de8 veloper claims as trade secret or confidential 

9 commercial or financial information; 

10 ‘‘(C) the signature of the individual filing 

11 the application or an authorized representative; 

12 ‘‘(D) a statement identifying the scope of 

13 the proposed technology certification intended 

14 to be introduced into interstate commerce under 

15 the application; 

16 ‘‘(E) information establishing that the de17 veloper submitting the application is an eligible 

18 person; 

19 ‘‘(F) quality procedures showing that eligi20 ble in vitro clinical tests covered under the tech21 nology certification will conform to the applica22 ble quality requirements of section 587K with 

23 respect to— 


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1 ‘‘(i) design controls, including related 

2 purchasing controls and acceptance activi3 ties; 

4 ‘‘(ii) complaint investigation, adverse 

5 event reporting, and corrections and re6 movals; and 

7 ‘‘(iii) process validation, as applicable; 

8 ‘‘(G) procedures for analytical and clinical 

9 validation, including all procedures for valida10 tion, verification, and acceptance criteria, and 

11 an explanation as to how such procedures, when 

12 used, provide a showing of analytical validity of 

13 eligible in vitro clinical tests within the pro14 posed scope of the technology certification order 

15 that is analytically and clinically valid; 

16 ‘‘(H) procedures that provide a showing 

17 that in vitro clinical tests covered by the pro18 posed scope of the technology certification order 

19 will be safe for individuals who come into con20 tact with in vitro clinical tests covered by such 

21 order; 

22 ‘‘(I) a proposed listing submission under 

23 section 587J(b) for in vitro clinical tests that 

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1 tification order, which shall not be construed to 

2 limit the developer from introducing additional 

3 tests not included in such submission under the 

4 same technology certification order; 

5 ‘‘(J) information concerning one or more 

6 representative in vitro clinical tests, including— 

7 ‘‘(i) a test within the scope of the 

8 technology certification application with 

9 the appropriate analytical complexity at 

10 the time of the submission of the applica11 tion under this section to serve as the rep12 resentative test and validate and run with13 in the developer’s stated scope; 

14 ‘‘(ii) the information specified in sub15 section (a) or (b) of section 587B, as ap16 plicable, for the representative in vitro clin17 ical test or tests, including information and 

18 data required pursuant to subsection 

19 (a)(2)(G) of section 587B, unless the Sec20 retary determines that such information is 

21 not necessary; 

22 ‘‘(iii) a summary of a risk assessment 

23 of the in vitro clinical test; 

24 ‘‘(iv) an explanation of the choice of 

25 the representative in vitro clinical test or 


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1 tests for the technology certification appli2 cation and how such test adequately dem3 onstrates the range of procedures that the 

4 developer includes in the application under 

5 subparagraphs (F), (G), (H), and (I); and 

6 ‘‘(v) a brief explanation of the ways in 

7 which the procedures included in the appli8 cation under subparagraphs (F), (G), (H), 

9 and (I) have been applied to the represent10 ative in vitro clinical test or tests; and 

11 ‘‘(K) such other information necessary to 

12 make a determination on a technology certifi13 cation application as the Secretary may deter14 mine necessary. 

15 ‘‘(3) REFERENCE TO EXISTING APPLICA16 TIONS.—With respect to the content requirements in 

17 the technology certification application described in 

18 paragraph (2), a developer may incorporate by ref19 erence any content of an application previously sub20 mitted by the developer. 

21 ‘‘(d) ACTION ON AN APPLICATION FOR TECHNOLOGY

22 CERTIFICATION.— 

23 ‘‘(1) SECRETARY RESPONSE.— 

24 ‘‘(A) IN GENERAL.—As promptly as prac25 ticable, and not later than 90 days after receipt 


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1 of an application under subsection (c), the Sec2 retary shall— 

3 ‘‘(i) issue a technology certification 

4 order granting the application, which shall 

5 specify the scope of the technology certifi6 cation, if the Secretary finds that all of the 

7 grounds in paragraph (3) are met; or 

8 ‘‘(ii) deny the application if the Sec9 retary finds (and sets forth the basis of 

10 such finding as part of or accompanying 

11 such denial) that one or more grounds for 

12 granting the application specified in para13 graph (3) are not met. 

14 ‘‘(B) EXTENSION.—The timeline described 

15 in subparagraph (A) may be extended by mu16 tual agreement between the Secretary and the 

17 applicant. 

18 ‘‘(2) DEFICIENT APPLICATIONS.— 

19 ‘‘(A) IN GENERAL.—If, after receipt of an 

20 application under this section, the Secretary de21 termines that any portion of such application is 

22 deficient, the Secretary, not later than 60 days 

23 after receipt of such application, shall provide 

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1 ciencies and identify the information required to 

2 resolve such deficiencies. 

3 ‘‘(B) CONVERTING TO PREMARKET APPLI4 CATIONS.—When responding to the deficiency 

5 letter, the developer may convert the application 

6 for technology certification under subsection (c) 

7 into a premarket application under section 

8 587B. 

9 ‘‘(3) TECHNOLOGY CERTIFICATION ORDER.— 

10 The Secretary shall issue an order granting a tech11 nology certification under this section if, on the 

12 basis of the information submitted to the Secretary 

13 as part of the application and any other information 

14 with respect to such applicant, the Secretary finds 

15 that— 

16 ‘‘(A) there is a showing that in vitro clin17 ical tests within the scope of the technology cer18 tification order will meet the applicable stand19 ard; 

20 ‘‘(B) the methods used in, and the facili21 ties or controls used for, the development of eli22 gible in vitro clinical tests covered by the pro23 posed scope of the technology certification con24 form to the applicable requirements of section 

25 587K with respect to— 


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1 ‘‘(i) design controls, including related 

2 purchasing controls and acceptance activi3 ties; 

4 ‘‘(ii) complaint investigation, adverse 

5 event reporting, and corrections and re6 movals; and 

7 ‘‘(iii) process validation, as applicable; 

8 ‘‘(C) based on a fair evaluation of all mate9 rial facts, the applicant’s proposed labeling and 

10 advertising are not false or misleading in any 

11 particular; 

12 ‘‘(D) the application does not contain a 

13 false statement of material fact; 

14 ‘‘(E) there is a showing that the represent15 ative in vitro clinical test or tests— 

16 ‘‘(i) meet the applicable standard; and 

17 ‘‘(ii) reasonably represent the range of 

18 procedures required to be submitted in the 

19 application; 

20 ‘‘(F) the applicant has agreed to permit, 

21 upon request, authorized employees of the Food 

22 and Drug Administration or persons accredited, 

23 or recognized under this Act, an opportunity to 

24 inspect at a reasonable time and in a reason25 able manner the facilities and all pertinent 


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1 equipment, finished and unfinished materials, 

2 containers, and labeling therein, including all 

3 things (including records, files, papers, and con4 trols) bearing on whether an in vitro clinical 

5 test is adulterated, misbranded, or otherwise in 

6 violation of this Act, and permits such author7 ized employees or persons accredited under this 

8 Act to view and to copy and verify all records 

9 pertinent to the application and the in vitro 

10 clinical test; and 

11 ‘‘(G) based on other data and information 

12 the Secretary may require under subsection 

13 (c)(2)(K), the Secretary finds that such data 

14 and information support granting a technology 

15 certification order. 

16 ‘‘(4) REVIEW OF DENIALS.—An applicant 

17 whose application has been denied under this sub18 section may obtain review of such denial under sec19 tion 587P. 

20 ‘‘(e) SUPPLEMENTS.— 

21 ‘‘(1) SUPPLEMENTAL APPLICATIONS.— 

22 ‘‘(A) IN GENERAL.—With respect to any of 

23 the following changes related to an in vitro clin24 ical test under a technology certification order, 

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1 tification order shall be submitted by the holder 

2 of the technology certification order describing 

3 such proposed changes, prior to introducing the 

4 in vitro clinical test that is the subject of the 

5 technology certification order into interstate 

6 commerce— 

7 ‘‘(i) any significant change to the pro8 cedures provided in support of the applica9 tion for technology certification submitted 

10 under subparagraph (G) or (H) of sub11 section (c)(2); or 

12 ‘‘(ii) any significant change to the 

13 procedures provided in support of the ap14 plication for technology certification sub15 mitted under subparagraph (F) of sub16 section (c)(2). 

17 ‘‘(B) SECRETARY ACTION ON SUPPLE18 MENTAL APPLICATIONS.—Any action by the 

19 Secretary on a supplemental application shall 

20 be in accordance with subsection (d), and any 

21 order resulting from such supplement shall be 

22 treated as an amendment to a technology cer23 tification order. 

24 ‘‘(2) CONTENT OF APPLICATION.— 


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1 ‘‘(A) IN GENERAL.—A supplemental appli2 cation for a change to an in vitro clinical test 

3 under a technology certification order shall— 

4 ‘‘(i) contain all necessary information 

5 to make a showing that any in vitro clin6 ical test affected by such change that is 

7 within the scope of the technology certifi8 cation order will meet the applicable stand9 ard; and 

10 ‘‘(ii) be limited to such information 

11 that is needed to support the change. 

12 ‘‘(B) CONTENT.—Unless otherwise speci13 fied by the Secretary, a supplemental applica14 tion under this subsection shall include— 

15 ‘‘(i) a description of the change, in16 cluding a rationale for implementing such 

17 change; 

18 ‘‘(ii) a description of how the change 

19 was evaluated; 

20 ‘‘(iii) data from a representative in 

21 vitro clinical test or tests that supports a 

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1 nology certification will meet the applicable 

2 standard; 

3 ‘‘(iv) as applicable, information to 

4 demonstrate that the modified procedure 

5 or procedures submitted under subsection 

6 (c)(2)(F) continue to conform to applicable 

7 requirements under section 587K; and 

8 ‘‘(v) any other information requested 

9 by the Secretary. 

10 ‘‘(3) CHANGES IN RESPONSE TO A PUBLIC

11 HEALTH RISK.— 

12 ‘‘(A) IN GENERAL.—If the holder of a 

13 technology certification makes a change to an 

14 in vitro clinical test or tests to address a poten15 tial risk to public health by adding a new speci16 fication or test method, such holder may imme17 diately implement such change and shall submit 

18 a notification for such change to the Secretary 

19 within 30 days. 

20 ‘‘(B) CONTENT.—Any notification to the 

21 Secretary under this paragraph shall include— 

22 ‘‘(i) a summary of the relevant 

23 change; 

24 ‘‘(ii) the rationale for implementing 

25 such change; 


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1 ‘‘(iii)(I) if such a change necessitates 

2 a change to the procedures reviewed as 

3 part of the granted technology certification 

4 order, the modified procedures; or 

5 ‘‘(II) if the procedures were not 

6 changed, an explanation as to why they 

7 were not changed; and 

8 ‘‘(iv) if such a change necessitates a 

9 change to the procedures reviewed as part 

10 of the granted technology certification 

11 order, data from a representative in vitro 

12 clinical test or tests that support a showing 

13 that, in using the modified procedures, all 

14 eligible in vitro clinical tests within the 

15 scope of the technology certification will 

16 meet the applicable standard. 

17 ‘‘(f) TEMPORARY HOLD.— 

18 ‘‘(1) IN GENERAL.—Subject to the process 

19 specified in paragraph (2), and based on one or 

20 more findings under paragraph (4), the Secretary 

21 may issue a temporary hold prohibiting any holder 

22 of a technology certification order issued under this 

23 section from introducing into interstate commerce 

24 an in vitro clinical test that was not previously the 

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1 porary hold shall identify the grounds for the tem2 porary hold under paragraph (4) and the rationale 

3 for such finding. 

4 ‘‘(2) PROCESS FOR ISSUING A TEMPORARY

5 HOLD.—If the Secretary makes a finding that a 

6 temporary hold may be warranted based on one or 

7 more grounds specified in paragraph (4), the Sec8 retary shall promptly notify the holder of the tech9 nology certification order of such finding and pro10 vide 30 calendar days for the developer to come into 

11 compliance with or otherwise resolve the finding. 

12 ‘‘(3) WRITTEN REQUESTS.—Any written re13 quest to the Secretary from the holder of a tech14 nology certification order that a temporary hold 

15 under paragraph (1) be removed shall receive a deci16 sion, in writing and specifying the reasons therefore, 

17 within 90 days after receipt of such request. Any 

18 such request shall include information to support the 

19 removal of the temporary hold. 

20 ‘‘(4) GROUNDS FOR TEMPORARY HOLD.—The 

21 Secretary may initiate a temporary hold under this 

22 subsection upon a finding that the holder of a tech23 nology certification order— 


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1 ‘‘(A) is not in compliance with the condi2 tions of the technology certification order pur3 suant to subsection (b)(1)(D); 

4 ‘‘(B) offers one or more in vitro clinical 

5 tests with advertising or labeling that is false or 

6 misleading; 

7 ‘‘(C) has reported a correction or removal 

8 of an in vitro clinical test that is offered under 

9 a technology certification order under this sec10 tion and has failed to demonstrate that the 

11 issue or issues causing the correction or re12 moval does not adversely impact the ability of 

13 other in vitro clinical tests offered under the 

14 same technology certification order to meet the 

15 applicable standard; or 

16 ‘‘(D) has introduced into interstate com17 merce an in vitro clinical test under a tech18 nology certification order and such test is adul19 terated or misbranded, based on a determina20 tion by the Secretary, and has failed to dem21 onstrate that the issue or issues causing the 

22 adulteration or misbranding does not adversely 

23 impact the ability of other in vitro clinical tests 

24 offered under the same technology certification 


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1 granted under this section to meet the applica2 ble standard. 

3 ‘‘(g) WITHDRAWAL.—The Secretary may, after due 

4 notice and opportunity for an informal hearing, issue an 

5 order withdrawing a technology certification order includ6 ing all tests introduced into interstate commerce under the 

7 technology certification order if the Secretary finds that— 

8 ‘‘(1) the application, supplement, or report 

9 under subsection (h) contains false or misleading in10 formation or fails to reveal a material fact; 

11 ‘‘(2) such holder fails to correct false or mis12 leading labeling or advertising upon the request of 

13 the Secretary; 

14 ‘‘(3) in connection with a technology certifi15 cation, the holder provides false or misleading infor16 mation to the Secretary; or 

17 ‘‘(4) the holder of such technology certification 

18 order fails to correct the grounds for a temporary 

19 hold within a timeframe specified in the temporary 

20 hold order. 

21 ‘‘(h) REPORTS TO CONGRESS.— 

22 ‘‘(1) IN GENERAL.—Not later than 1 year after 

23 the effective date of the VALID Act of 2022, and 

24 annually thereafter for the next 4 years, the Sec25 retary shall submit to the Committee on Health, 


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1 Education, Labor, and Pensions of the Senate and 

2 the Committee on Energy and Commerce of the 

3 House of Representatives, and make publicly avail4 able, including through posting on the website of the 

5 Food and Drug Administration, a report containing 

6 the information described in paragraph (2). 

7 ‘‘(2) CONTENT.— 

8 ‘‘(A) IN GENERAL.—Each report under 

9 paragraph (1) shall address, at a minimum— 

10 ‘‘(i) the total number of applications 

11 for technology certifications filed, granted, 

12 withdrawn and denied; 

13 ‘‘(ii) the total number of technology 

14 certification orders the Secretary put on 

15 temporary hold under subsection (h) and 

16 the number of technology certification or17 ders withdrawn under subsection (i); 

18 ‘‘(iii) the types of technologies for 

19 which the Secretary granted technology 

20 certification orders; 

21 ‘‘(iv) the total number of holders of 

22 technology certification orders that are in 

23 effect; and 

24 ‘‘(v) the total number of in vitro clin25 ical test categories that required premarket 


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1 review under section 587B that were redes2 ignated as eligible in vitro clinical tests 

3 under this section. 

4 ‘‘(B) FINAL REPORT.—The fifth report 

5 submitted under paragraph (1) shall include a 

6 summary of, and responses to, comments raised 

7 in the docket. 

8 ‘‘(C) PERFORMANCE REPORTS.—The re9 ports required under this section may be issued 

10 with performance reports as required under sec11 tion 829 of the VALID Act of 2022. 

12 ‘‘(i) PUBLIC MEETING AND INPUT.— 

13 ‘‘(1) PUBLIC DOCKET.—Not later than 30 days 

14 after the date of enactment of the VALID Act of 

15 2022, the Secretary shall establish a public docket to 

16 receive comments concerning recommendations for 

17 implementation of this section, including criteria and 

18 procedures for subsections (c) through (h). The pub19 lic docket shall remain open for at least 1 year after 

20 the establishment of the public docket. 

21 ‘‘(2) PUBLIC MEETING.—Not later than 180 

22 days after the date of enactment of the VALID Act 

23 of 2022, the Secretary shall convene a public meet24 ing to which stakeholders from organizations rep25 resenting patients and consumers, academia, and the 


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1 in vitro clinical test industry are invited to discuss 

2 the technology certification process including appli3 cation requirements, inspections, alignment with 

4 third-party accreditors, and the definition of the 

5 term ‘technology’ under section 587. 

6 ‘‘(j) REGULATIONS.—The Secretary shall issue regu7 lations regarding the technology certification process, in8 cluding describing criteria or procedures relating to tech9 nology certification under this section, which shall be sub10 ject to public comment for a minimum of 60 days from 

11 issuance prior to finalizing such regulations after consid12 ering the comments received. The regulation shall include 

13 an outline of the application process, opportunities to meet 

14 with officials of the Food and Drug Administration, and 

15 plans to streamline inspections. 

16 ‘‘(k) NOTIFICATION.— 

17 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

18 (a)(1), a first-of-a-kind in vitro clinical test or a 

19 combination product that meets the definition of a 

20 moderate-risk test under section 587A may be intro21 duced into interstate commerce under a technology 

22 certification order that has been issued by the Sec23 retary, subject to other applicable requirements if— 

24 ‘‘(A) the developer provides notification to 

25 the Secretary 60 days prior to introducing such 


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1 tests into interstate commerce that includes in2 formation demonstrating that the test is mod3 erate-risk and within the scope of the applicable 

4 technology certification order; and 

5 ‘‘(B) the Secretary has not issued a notifi6 cation to the developer under paragraph (2) be7 fore such time has elapsed. 

8 ‘‘(2) NOTIFICATION FROM SECRETARY.—The 

9 Secretary shall issue a notification to the developer 

10 that such test may not be introduced into interstate 

11 commerce under such order if the Secretary deter12 mines that— 

13 ‘‘(A) such test— 

14 ‘‘(i) does not meet the definition of a 

15 moderate-risk test under section 587A; 

16 ‘‘(ii) is not eligible to be introduced 

17 into interstate commerce under the ref18 erenced technology certification order 

19 issued by the Secretary; or 

20 ‘‘(iii) is not eligible for technology cer21 tification under subsection (b)(2); or 

22 ‘‘(B) based on the information included in 

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1 minations described in clauses (i), (ii), and (iii) 

2 of subparagraph (A). 

3 ‘‘SEC. 587E. MITIGATING MEASURES. 

4 ‘‘(a) ESTABLISHMENT OF MITIGATING MEASURES.— 

5 ‘‘(1) ESTABLISHING, CHANGING, OR WITH6 DRAWING.— 

7 ‘‘(A) ESTABLISHMENT.—The Secretary 

8 may establish and require, on the basis of evi9 dence, mitigating measures for any in vitro clin10 ical test or category of in vitro clinical tests 

11 with the same indications for use that is intro12 duced or delivered for introduction into inter13 state commerce after the establishment of such 

14 mitigating measures. 

15 ‘‘(B) METHODS OF ESTABLISHMENT.—The 

16 Secretary may establish mitigating measures— 

17 ‘‘(i) under the process set forth in 

18 subparagraph (D); 

19 ‘‘(ii) as provided under section 587F; 

20 or 

21 ‘‘(iii) through a premarket approval or 

22 technology certification order, which may 

23 establish mitigating measures for an indi24 vidual in vitro clinical test or a category of 

25 in vitro clinical tests. 


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1 ‘‘(C) METHODS OF CHANGE OR WITH2 DRAWAL.—The Secretary may change or with3 draw mitigating measures— 

4 ‘‘(i) under the process set forth in 

5 subparagraph (D); or 

6 ‘‘(ii) as provided under section 587F. 

7 ‘‘(D) PROCESS FOR ESTABLISHMENT, 

8 CHANGE, OR WITHDRAWAL.—Notwithstanding 

9 subchapter II of chapter 5 of title 5, United 

10 States Code, the Secretary may, upon the ini11 tiative of the Secretary or upon petition of an 

12 interested person— 

13 ‘‘(i) establish, change, or withdraw 

14 mitigating measures for an in vitro clinical 

15 test or category of in vitro clinical tests 

16 by— 

17 ‘‘(I) publishing a proposed order 

18 in the Federal Register; 

19 ‘‘(II) providing an opportunity 

20 for public comment for a period of not 

21 less than 30 60 calendar days; and 

22 ‘‘(III) after consideration of any 

23 comments submitted, publishing a 

24 final order in the Federal Register 

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1 mitted, and which shall include a rea2 sonable transition period. 

3 ‘‘(E) EFFECT OF MITIGATING MEASURES

4 ON GRANDFATHERED TESTS.—A mitigating 

5 measure shall not be required by the Secretary 

6 for an in vitro clinical test subject to section 

7 587G(a), unless otherwise provided under sec8 tion 587F. 

9 ‘‘(2) IN VITRO CLINICAL TESTS PREVIOUSLY

10 CLEARED OR EXEMPT AS DEVICES WITH SPECIAL

11 CONTROLS.— 

12 ‘‘(A) IN GENERAL.—Any special controls 

13 applicable to an in vitro clinical test previously 

14 cleared or exempt under section 510(k), or clas15 sified under section 513(f)(2) prior to date of 

16 enactment of the VALID Act of 2022, including 

17 any such special controls established during the 

18 period beginning on the date of enactment of 

19 the VALID Act of 2022 and ending on the ef20 fective date of such Act (as described in section 

21 5(b) of such Act)— 

22 ‘‘(i) shall continue to apply to such in 

23 vitro clinical test after such effective date; 

24 and 


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1 ‘‘(ii) are deemed to be mitigating 

2 measures as of the effective date specified 

3 in section 825(a)(1)(A) of the VALID Act 

4 of 2022. 

5 ‘‘(B) CHANGES.—Notwithstanding sub6 paragraph (A), the Secretary may establish, 

7 change, or withdraw mitigating measures for 

8 such tests or category of tests using the proce9 dures under paragraph (1). 

10 ‘‘(b) DOCUMENTATION.— 

11 ‘‘(1) IN VITRO CLINICAL TESTS SUBJECT TO

12 PREMARKET REVIEW.—The developer of an in vitro 

13 clinical test subject to premarket review under sec14 tion 587B and to which mitigating measures apply 

15 shall— 

16 ‘‘(A) in accordance with section 

17 587B(c)(2)(G)(i), submit documentation to the 

18 Secretary as part of the application for the test 

19 under subsection (c) or (d) of section 587B 

20 demonstrating that such mitigating measures 

21 have been met; 

22 ‘‘(B) if such application is approved, main23 tain documentation demonstrating that such 

24 mitigating measures continue to be met fol25 lowing a test modification by the developer; and 


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1 ‘‘(C) make such documentation available to 

2 the Secretary upon request or inspection. 

3 ‘‘(2) OTHER TESTS.—The developer of an in 

4 vitro clinical test that is offered under a technology 

5 certification order or other exemption from pre6 market review under section 587B and to which 

7 mitigating measures apply shall— 

8 ‘‘(A) maintain documentation in accord9 ance with the applicable quality requirements 

10 under section 587J demonstrating that such 

11 mitigating measures continue to be met fol12 lowing a test modification by the developer; 

13 ‘‘(B) make such documentation available to 

14 the Secretary upon request or inspection; and 

15 ‘‘(C) include in the performance summary 

16 for such test a brief description of how such 

17 mitigating measures are met, if applicable. 

18 ‘‘SEC. 587F. REGULATORY PATHWAY DESIGNATION. 

19 ‘‘(a) PATHWAY DETERMINATIONS.— 

20 ‘‘(1) IN GENERAL.—After considering available 

21 evidence with respect to an in vitro clinical test or 

22 category of in vitro clinical tests with the same in23 tended use, including the identification, establish24 ment, and implementation of mitigating measures 

25 under section 587E, as appropriate, the Secretary 


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1 may, upon the initiative of the Secretary or upon re2 quest of a developer, determine that— 

3 ‘‘(A) such in vitro clinical test is high-risk 

4 and subject to premarket review under section 

5 587B; 

6 ‘‘(B) such in vitro clinical tests, including 

7 a first of a kind test, is moderate-risk and sub8 ject to abbreviated premarket review under sec9 tion 587B(d) or technology certification under 

10 section 587D(b)(2); or 

11 ‘‘(C) such in vitro clinical test, including a 

12 first of a kind test is low-risk or otherwise ex13 empt from premarket review under section 

14 587B. 

15 ‘‘(2) REQUESTS.— 

16 ‘‘(A) SUBMISSIONS BY DEVELOPERS.— 

17 ‘‘(i) SPECIAL PREMARKET REVIEW; 

18 TECHNOLOGY CERTIFICATION.—A devel19 oper submitting a request that the Sec20 retary make a determination as described 

21 in paragraph (1)(B) shall submit informa22 tion to support that the in vitro clinical 

23 test is moderate-risk or propose mitigating 

24 measures, if applicable, that would support 

25 such a determination. 


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1 ‘‘(ii) LOW-RISK; EXEMPT FROM PRE2 MARKET REVIEW.—A developer submitting 

3 a request that the Secretary make a deter4 mination as described in paragraph (1)(C) 

5 shall submit information that the in vitro 

6 clinical test is low-risk, or otherwise appro7 priate for exemption from premarket re8 view under section 587B and propose miti9 gating measures, if applicable, that would 

10 support such a determination. 

11 ‘‘(B) RESPONSE BY THE SECRETARY.— 

12 After receiving a request under clause (i) or (ii) 

13 of subparagraph (A), the Secretary shall pro14 vide a timely response describing whether or 

15 not the Secretary will initiate the process for 

16 making a determination under paragraph 

17 (1)(B) or (1)(C) as described in paragraph (4). 

18 ‘‘(3) SUFFICIENCY OF MITIGATING MEAS19 URES.—When determining whether mitigating meas20 ures for an in vitro clinical test, or category of in 

21 vitro clinical tests, are sufficient to make such test 

22 moderate-risk or low-risk, the Secretary shall take 

23 into account the following: 

24 ‘‘(A) The degree to which the technology 

25 for the intended use of the in vitro clinical test 


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1 is well-characterized, taking into consideration 

2 factors that include one or more of the fol3 lowing: 

4 ‘‘(i) Peer-reviewed literature. 

5 ‘‘(ii) Practice guidelines. 

6 ‘‘(iii) Consensus standards. 

7 ‘‘(iv) Recognized standards of care. 

8 ‘‘(v) Use of such technology, including 

9 historical use. 

10 ‘‘(vi) Multiple scientific publications 

11 by different authors. 

12 ‘‘(vii) Adoption by the scientific or 

13 clinical community. 

14 ‘‘(viii) Real world evidence. 

15 ‘‘(B) Whether the criteria for performance 

16 of the test are well-established to be sufficient 

17 for the intended use. 

18 ‘‘(C) The clinical circumstances under 

19 which the in vitro clinical test is used, including 

20 whether the in vitro clinical test is the sole de21 terminate for the diagnosis or treatment of the 

22 targeted disease, and the availability of other 

23 tests (such as confirmatory or adjunctive tests) 

24 or relevant material standards. 


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1 ‘‘(D) Whether such mitigating measures 

2 sufficiently mitigate the risk of harm such that 

3 the test or category of tests is moderate-risk or 

4 low-risk. 

5 ‘‘(4) PROCESS.— 

6 ‘‘(A) IN GENERAL.—For a test that is not 

7 first-of-a-kind, any action under paragraph (1) 

8 shall be made by publication of a notice of such 

9 proposed action on the website of the Food and 

10 Drug Administration, the consideration of com11 ments to a public docket on such proposal, and 

12 publication of a final action on such website 

13 within 60 calendar days of the close of the com14 ment period posted to such public docket, not15 withstanding subchapter II of chapter 5 of title 

16 5, United States Code. 

17 ‘‘(B) PROCESS FOR FIRST-OF-A-KIND

18 TEST.—In the case of an in vitro clinical test 

19 that is first-of-a-kind, the process is as follows: 

20 ‘‘(i) Any determination that the test is 

21 subject to premarket approval or abbre22 viated premarket review under subpara23 graph (A) or (B) of paragraph (1) shall be 

24 published on the website of the Food and 

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1 clause II of chapter 5 of title 5, United 

2 States Code, only after the in vitro clinical 

3 test is approved under section 587B. Until 

4 that time, the determination shall not be 

5 binding on other in vitro clinical tests. 

6 ‘‘(ii) Any determination other than 

7 those made under clause (i) shall be made 

8 by publication of a notice of final action on 

9 the website of the Food and Drug Admin10 istration, notwithstanding subchapter II of 

11 chapter 5 of title 5, United States Code. 

12 ‘‘(b) TRANSITION PERIOD.—Upon a decision by the 

13 Secretary to change a regulatory pathway designation, or 

14 reclassifies an in vitro clinical test, or category of in vitro 

15 clinical tests, the Secretary shall provide an appropriate 

16 transition period with respect to any new requirements. 

17 ‘‘(c) APPEALS.—A decision by the Secretary under 

18 this section shall be deemed a significant decision subject 

19 to appeal under section 587P. 

20 ‘‘(d) ADVISORY COMMITTEE.—The Secretary may re21 quest recommendations from an advisory committee under 

22 section 587H pursuant to carrying out this section. 

23 ‘‘(e) REQUEST FOR INFORMAL FEEDBACK.—Before 

24 submitting a premarket application or technology certifi25 cation application for an in vitro clinical test— 


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1 ‘‘(1) the developer of the test may submit to the 

2 Secretary a written request for a meeting, con3 ference, or written feedback to discuss and provide 

4 information relating to the regulation of such in 

5 vitro clinical test which may include— 

6 ‘‘(A) the submission process and the type 

7 and amount of evidence expected to dem8 onstrate the applicable standard; 

9 ‘‘(B) which regulatory pathway is appro10 priate for an in vitro clinical test; and 

11 ‘‘(C) an investigation plan for an in vitro 

12 clinical test, including a clinical protocol; and 

13 ‘‘(2) upon receipt of such a request, the Sec14 retary shall— 

15 ‘‘(A) if a meeting is requested— 

16 ‘‘(i) within 60 calendar days after 

17 such receipt, or within such time period as 

18 may be agreed to by the developer, meet or 

19 confer with the developer submitting the 

20 request; and 

21 ‘‘(ii) within 15 calendar days after 

22 such meeting or conference, provide to the 

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1 sions reached in the meeting or conference; 

2 and 

3 ‘‘(B) if written feedback is requested, pro4 vide feedback to the requestor within 75 days 

5 after such receipt. 

6 ‘‘SEC. 587G. GRANDFATHERED IN VITRO CLINICAL TESTS. 

7 ‘‘(a) IN GENERAL.—Subject to subsection (d), an in 

8 vitro clinical test is exempt from the requirements of this 

9 subchapter specified in subsection (b) if— 

10 ‘‘(1) the test was first offered for clinical use 

11 before the date of enactment of the VALID Act of 

12 2022; 

13 ‘‘(2) the was developed by a clinical laboratory 

14 for which a certificate was in effect under section 

15 353 of the Public Health Service Act that meets the 

16 requirements for performing tests of high com17 plexity; 

18 ‘‘(3) the test is performed— 

19 ‘‘(A) in the same clinical laboratory in 

20 which the test was developed for which a certifi21 cation is still in effect under section 353 of the 

22 Public Health Service Act that meets the re23 quirements to perform tests of high complexity; 

24 ‘‘(B) by another clinical laboratory for 

25 which a certificate is in effect under section 353 


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1 of such Act that meets the requirements to per2 form tests of high complexity, and that is with3 in the same corporate organization and having 

4 common ownership by the same parent corpora5 tion as the laboratory in which the test was de6 veloped; or 

7 ‘‘(C) in the case of a test that was devel8 oped by the Centers for Disease Control and 

9 Prevention or another laboratory a public 

10 health laboratory network coordinated or man11 aged by the Centers for Disease Control and 

12 Prevention, by a clinical laboratory for which a 

13 certificate is in effect under section 353 of such 

14 Act that meets the requirements to perform 

15 tests of high complexity, and that is within a 

16 public health laboratory network coordinated or 

17 managed by the Centers for Disease Control 

18 and Prevention; 

19 ‘‘(4) the test does not have in effect an ap20 proval under section 515, a clearance under section 

21 510(k), an authorization under section 513(f)(2), or 

22 an exemption under section 520(m), or licensure 

23 under section 351 of the Public Health Service Act; 

24 ‘‘(5) any modification to the test on or after the 

25 date of enactment of the VALID Act of 2022 made 


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1 by the initial developer and conform with section 

2 587C(a)(6)(A)(ii) and does not meet the criterial in 

3 subsection (d)(1); 

4 ‘‘(6) the test is not for investigational use; 

5 ‘‘(7) the test is offered with an order from an 

6 authorized person as required under section 353 of 

7 the Public Health Service Act, and was offered with 

8 a prescription required under section 809.30(f) of 

9 title 21, Code of Federal Regulations prior to the ef10 fective date of this subchapter; 

11 ‘‘(8) the test is not for use with home specimen 

12 collection, unless the specimen is collected with a 

13 collection container, receptacle, or kit that— 

14 ‘‘(A) has been approved, cleared, or au15 thorized by the Secretary for home specimen 

16 collection and the collection is performed pursu17 ant to the approved, cleared, or authorized la18 beling, including any indication for use as pre19 scription use or over-the-counter use, or 

20 ‘‘(B) is exempt from premarket review and 

21 its use is consistent with applicable limitations 

22 on the exemption; 

23 ‘‘(9) is not a specimen receptacle or instrument 

24 ‘‘(10) each test report template for the test 

25 bears a statement that reads as follows: ‘This in 


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1 vitro clinical test has not been reviewed by the Food 

2 and Drug Administration.’; and 

3 ‘‘(11) the developer of the test— 

4 ‘‘(A) maintains documentation dem5 onstrating that the test meets and continues to 

6 meet the criteria set forth in this subsection; 

7 and 

8 ‘‘(B) makes such documentation available 

9 to the Secretary upon request. 

10 ‘‘(b) EXEMPTIONS APPLICABLE TO GRAND11 FATHERED TESTS.—An in vitro clinical test that meets 

12 the criteria specified in subsection (a) is exempt from pre13 market review under 587B, labeling requirements under 

14 587L, and test design requirements and quality require15 ments under 587K, and may be lawfully offered subject 

16 to the other applicable requirements of this Act. 

17 ‘‘(c) MODIFICATIONS.—In the case of an in vitro clin18 ical test that meets the criteria specified in subsection (a), 

19 such test continues to qualify for the exemptions described 

20 in subsection (b) if the test is modified and the modifica21 tion is not of a type described in subsection (a)(5), and 

22 the person modifying such in vitro clinical test— 

23 ‘‘(1) documents each such modification and 

24 maintains documentation of the basis for such deter25 mination; 


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1 ‘‘(2) provides such documentation relating to 

2 the change to the Secretary upon request or inspec3 tion; and 

4 ‘‘(3) does not modify the in vitro clinical test 

5 such that it no longer meets the criteria under sub6 section (a). 

7 ‘‘(d) REQUEST FOR INFORMATION.— 

8 ‘‘(1) CRITERIA.—The criteria described in this 

9 paragraph are any of the following: 

10 ‘‘(A) There is insufficient valid scientific 

11 evidence to support that the test is analytically 

12 valid or clinically valid. 

13 ‘‘(B) Such in vitro clinical test is being of14 fered by its developer with any false or mis15 leading analytical or clinical claims. 

16 ‘‘(C) It is probable that such in vitro clin17 ical test will cause serious adverse health con18 sequences. 

19 ‘‘(2) PROCESS.— 

20 ‘‘(A) WRITTEN REQUEST FOR INFORMA21 TION.—The Secretary may issue a written re22 quest to a developer identifying specific sci23 entific concerns, based on credible information, 

24 with an in vitro clinical test, which indicate that 

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1 graph (1) apply to such in vitro clinical tests. 

2 Such written request shall include specific infor3 mation requests pertaining to such criteria. 

4 ‘‘(B) DEADLINE FOR SUBMITTING INFOR5 MATION.—Not later than 45 days after receiv6 ing a request for information under subpara7 graph (A)— 

8 ‘‘(i) the developer of an in vitro clin9 ical test— 

10 ‘‘(I) may seek a teleconference 

11 prior to the submission of information 

12 under clause (ii) to discuss the Sec13 retary’s request; and 

14 ‘‘(II) shall submit the informa15 tion requested pursuant to subpara16 graph (A) within 30 days of receipt of 

17 such request; and 

18 ‘‘(ii) the Secretary shall— 

19 ‘‘(I) schedule a teleconference re20 quested under clause (i)(I); and 

21 ‘‘(II) hold a teleconference so re22 quested within 10 days of the Sec23 retary’s receipt of the information re24 quested under clause (i)(II). 


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1 ‘‘(C) REVIEW DEADLINE.—Upon receiving 

2 a submission under subparagraph (B), the Sec3 retary shall— 

4 ‘‘(i) review the submitted information 

5 within 45 calendar days of such receipt, 

6 which may include communication with the 

7 developer; and 

8 ‘‘(ii) determine whether the criteria 

9 listed in paragraph (1) apply to the in 

10 vitro clinical test and communicate such 

11 determination to the developer as described 

12 in subparagraph (D). 

13 ‘‘(D) COMMUNICATION AND RESULTS OF

14 DETERMINATION.—The Secretary shall notify 

15 the developer, in writing, of the Secretary’s de16 termination under subparagraph (C), as follows: 

17 ‘‘(i) If the Secretary determines that 

18 none of the criteria listed in paragraph (1) 

19 apply to the in vitro clinical test, such test 

20 shall be exempt from relevant requirements 

21 of this subchapter, as set forth in sub22 section (b), subject to applicable limitation. 

23 ‘‘(ii) If the Secretary determines that 

24 one or more of the criteria listed in sub25 paragraph (1) apply to the test but such a 


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1 determination may be resolved within a 

2 reasonable time, and the test has not been 

3 previously subject to this subsection on the 

4 basis of the same or substantially similar 

5 scientific concerns identified in the written 

6 request issued under paragraph 

7 (d)(2)(A)— 

8 ‘‘(I) the Secretary shall notify the 

9 developer of such a determination and 

10 allow the developer to seek a tele11 conference to discuss the finding; 

12 ‘‘(II) the developer shall submit 

13 information demonstrating resolution 

14 of the determination within 15 days of 

15 receiving the notification; and 

16 ‘‘(III) the Secretary shall make a 

17 determination within 30 days of the 

18 submission of information as to 

19 whether the criteria under paragraph 

20 (1) apply to the test. 

21 ‘‘(iii) If the Secretary determines that 

22 none of the criteria listed in paragraph (1) 

23 apply to the test, such test shall be exempt 

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1 chapter as set forth in subsection (b), sub2 ject to applicable limitations. 

3 ‘‘(iv) If the Secretary determines that 

4 one or more of the criteria listed in para5 graph (1) apply to the in vitro clinical test, 

6 such test is not exempt as set forth in this 

7 section and shall not be offered unless ap8 proved under section 587B, offered under 

9 a technology certification order under sec10 tion 587D, or offered as a low-risk test. 

11 upon a determination by the Secretary 

12 pursuant to section 587F. 

13 ‘‘(v) If the Secretary determines that 

14 one or more of the criteria listed in para15 graph (1) apply to the in vitro clinical test 

16 and clause (ii) does not apply, the in vitro 

17 clinical test is not exempt as set forth in 

18 section and shall not be offered unless ap19 proved under section 587B, offered under 

20 a technology certification order under sec21 tion 587D, or offered as a low-risk test 

22 upon a determination by the Secretary 

23 pursuant to section 587F. 


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1 ‘‘SEC. 587H. ADVISORY COMMITTEES. 

2 ‘‘(a) IN GENERAL.—The Secretary may establish ad3 visory committees or use advisory committee panels of ex4 perts established before the date of enactment of the 

5 VALID Act of 2022 (including a device classification 

6 panel under section 513) for the purposes of providing ex7 pert scientific advice and making recommendations related 

8 to— 

9 ‘‘(1) the approval of an application for an in 

10 vitro clinical test submitted under this subchapter, 

11 including for evaluating, as applicable, the analytical 

12 validity, clinical validity, and safety of in vitro clin13 ical tests; 

14 ‘‘(2) the potential effectiveness of mitigating 

15 measures for a determination of the applicable regu16 latory pathway under section 587F(b) or risk eval17 uation for an in vitro clinical test or tests; 

18 ‘‘(3) quality requirements under section 587K 

19 or applying such requirements to in vitro clinical 

20 tests developed or imported by developers; 

21 ‘‘(4) appeals under section 587P; or 

22 ‘‘(5) such other purposes as the Secretary de23 termines appropriate. 

24 ‘‘(b) APPOINTMENTS.— 

25 ‘‘(1) VOTING MEMBERS.—The Secretary shall 

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1 section (a), as voting members, individuals who are 

2 qualified by training and experience to evaluate in 

3 vitro clinical tests referred to the committee for the 

4 purposes specified in subsection (a), including indi5 viduals with, to the extent feasible, scientific exper6 tise in the development of such in vitro clinical tests, 

7 laboratory operations, and the use of in vitro clinical 

8 tests. The Secretary shall designate one member of 

9 each committee to serve as chair. 

10 ‘‘(2) NONVOTING MEMBERS.—In addition to the 

11 individuals appointed pursuant to paragraph (1), the 

12 Secretary shall appoint to each committee estab13 lished under subsection (a), as nonvoting members— 

14 ‘‘(A) a representative of consumer inter15 ests; and 

16 ‘‘(B) a representative of interests of in 

17 vitro clinical test developers not directly af18 fected by the matter to be brought before the 

19 committee. 

20 ‘‘(3) LIMITATION.—No individual who is a reg21 ular full-time employee of the United States and en22 gaged in the administration of this Act may be a 

23 member of any advisory committee established under 

24 subsection (a). 


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1 ‘‘(4) EDUCATION AND TRAINING.—The Sec2 retary shall, as appropriate, provide education and 

3 training to each new committee member before such 

4 member participates in a committee’s activities, in5 cluding education regarding requirements under this 

6 Act and related regulations of the Secretary, and the 

7 administrative processes and procedures related to 

8 committee meetings. 

9 ‘‘(5) MEETINGS.—The Secretary shall ensure 

10 that scientific advisory committees meet regularly 

11 and at appropriate intervals so that any matter to 

12 be reviewed by such a committee can be presented 

13 to the committee not more than 60 calendar days 

14 after the matter is ready for such review. Meetings 

15 of the committee may be held using electronic or tel16 ephonic communication to convene the meetings. 

17 ‘‘(6) COMPENSATION.—Members of an advisory 

18 committee established under subsection (a), while at19 tending meetings or conferences or otherwise en20 gaged in the business of the advisory committee— 

21 ‘‘(A) shall be entitled to receive compensa22 tion at rates to be fixed by the Secretary, but 

23 not to exceed the daily equivalent of the rate in 

24 effect for positions classified above level GS–15 

25 of the General Schedule; and 


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1 ‘‘(B) may be allowed travel expenses as au2 thorized by section 5703 of title 5, United 

3 States Code, for employees serving intermit4 tently in the Government service. 

5 ‘‘(c) GUIDANCE.—The Secretary may issue guidance 

6 on the policies and procedures governing advisory commit7 tees established under subsection (a). 

8 ‘‘SEC. 587I. BREAKTHROUGH IN VITRO CLINICAL TESTS. 

9 ‘‘(a) IN GENERAL.—The purpose of this section is 

10 to encourage the Secretary, and provide the Secretary with 

11 sufficient authority, to apply efficient and flexible ap12 proaches to expedite the development of, and prioritize the 

13 review of, in vitro clinical tests that represent break14 through technologies. 

15 ‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 

16 shall establish a program to expedite the development of, 

17 and provide for the priority review of, in vitro clinical 

18 tests. 

19 ‘‘(c) ELIGIBILITY.—The program developed under 

20 subsection (b) shall be available for any in vitro clinical 

21 test that— 

22 ‘‘(1) provides or enables more effective treat23 ment or diagnosis of life-threatening or irreversibly 

24 debilitating human disease or conditions compared 

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1 ing an in vitro clinical test offered under a tech2 nology certification order; and 

3 ‘‘(2) is a test— 

4 ‘‘(A) that represents a breakthrough tech5 nology; 

6 ‘‘(B) for which no approved or cleared al7 ternative in vitro clinical test exists, including 

8 no in vitro clinical test offered under a tech9 nology certification order; 

10 ‘‘(C) that offers a clinically meaningful ad11 vantage over any existing alternative in vitro 

12 clinical test that is approved or cleared (includ13 ing any in vitro clinical test offered under a 

14 technology certification order), including the po15 tential to reduce or eliminate the need for hos16 pitalization, improve patient quality of life, fa17 cilitate patients’ ability to manage their own 

18 care (such as through self-directed personal as19 sistance), or establish long-term clinical effi20 ciencies; or 

21 ‘‘(D) the availability of which is in the best 

22 interest of patients or public health. 

23 ‘‘(d) DESIGNATION.— 

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1 quest that the Secretary designate the in vitro clin2 ical test for expedited development and priority re3 view. Any such request for designation may be made 

4 at any time prior to, or at the time of, the submis5 sion of an application under section 587B or 587D, 

6 and shall include information demonstrating that the 

7 test meets the criteria described in subsection (c). 

8 ‘‘(2) DETERMINATION.—Not later than 60 cal9 endar days after the receipt of a request under para10 graph (1), the Secretary shall determine whether the 

11 in vitro clinical test that is the subject of the request 

12 meets the criteria described in subsection (c). If the 

13 Secretary determines that the test meets the criteria, 

14 the Secretary shall designate the test for expedited 

15 development and priority review. 

16 ‘‘(3) REVIEW.—Review of a request under para17 graph (1) shall be undertaken by a team that is 

18 composed of experienced staff and senior managers 

19 of the Food and Drug Administration. 

20 ‘‘(4) WITHDRAWAL.— 

21 ‘‘(A) IN GENERAL.—The designation of an 

22 in vitro clinical test under this subsection is 

23 deemed to be withdrawn, and such in vitro clin24 ical test shall no longer be eligible for designa25 tion under this section, if an application for apVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00255 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 proval for such test under section 587B or 

2 587D is denied. Such test shall be eligible for 

3 breakthrough designation upon a new request 

4 for such designation. 

5 ‘‘(B) EXCEPTION.—The Secretary may not 

6 withdraw a designation granted under this sub7 section based on the subsequent approval or 

8 technology certification of another in vitro clin9 ical test that— 

10 ‘‘(i) is designated under this section; 

11 or 

12 ‘‘(ii) was given priority review under 

13 section 515B. 

14 ‘‘(e) ACTIONS.—For purposes of expediting the devel15 opment and review of in vitro clinical tests under this sec16 tion, the Secretary may take the actions and additional 

17 actions set forth in paragraphs (1) and (2), respectively, 

18 of section 515B(e) when reviewing such tests. Any ref19 erence or authorization in section 515B(e) with respect 

20 to a device shall be deemed a reference or authorization 

21 with respect to an in vitro clinical test for purposes of this 

22 section. 

23 ‘‘(f) GUIDANCE.—Not later than the date specified 

24 for final guidance under section 825 of the VALID Act 


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1 of 2022, the Secretary shall issue final guidance on the 

2 implementation of this section. Such guidance shall— 

3 ‘‘(1) set forth the process by which a person 

4 may seek a designation under subsection (d); 

5 ‘‘(2) provide a template for request under sub6 section (d); 

7 ‘‘(3) identify the criteria the Secretary will use 

8 in evaluating a request for designation; and 

9 ‘‘(4) identify the criteria and processes the Sec10 retary will use to assign a team of staff, including 

11 team leaders, to review in vitro clinical tests des12 ignated for expedited development and priority re13 view, including any training required for such per14 sonnel to ensure effective and efficient review. 

15 ‘‘(g) RULES OF CONSTRUCTION.—Nothing in this 

16 section shall be construed to affect— 

17 ‘‘(1) the criteria and standards for evaluating 

18 an application pursuant to section 587B or 587D, 

19 including the recognition of valid scientific evidence 

20 as described in section 587(17) and consideration 

21 and application of the least burdensome means de22 scribed under section 587AA(c); 

23 ‘‘(2) the authority of the Secretary with respect 

24 to clinical holds under section 587R; 


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1 ‘‘(3) the authority of the Secretary to act on an 

2 application pursuant to section 587B before comple3 tion of an establishment inspection, as the Secretary 

4 determines appropriate; or 

5 ‘‘(4) the authority of the Secretary with respect 

6 to postmarket surveillance under sections 587L(d) 

7 and 587Y. 

8 ‘‘SEC. 587J. REGISTRATION AND LISTING. 

9 ‘‘(a) REGISTRATION REQUIREMENT.— 

10 ‘‘(1) IN GENERAL.—Each person described in 

11 subsection (b)(1) shall— 

12 ‘‘(A) during the period beginning on Octo13 ber 1 and ending on December 31 of each year, 

14 register with the Secretary the name of such 

15 person, places of business of such person, all es16 tablishments engaged in the activities specified 

17 under this paragraph, the establishment reg18 istration number of each such establishment, 

19 and a point of contact for each such establish20 ment, including an electronic point of contact; 

21 and 

22 ‘‘(B) submit an initial registration con23 taining the information required under subpara24 graph (A) not later than— 


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1 ‘‘(i) the effective date of this section if 

2 such establishment is engaged in any activ3 ity described in subsection (b)(1) on such 

4 effective date, unless the Secretary estab5 lishes by guidance a date later than such 

6 implementation date for all or a category 

7 of such establishments; or 

8 ‘‘(ii) 30 days prior to engaging in any 

9 activity described in subsection (b)(1), if 

10 such establishment is not engaged in any 

11 activity described in this paragraph on 

12 such effective date. 

13 ‘‘(2) REGISTRATION NUMBERS.—The Secretary 

14 may assign a registration number to any person or 

15 an establishment registration number to any estab16 lishment registered in accordance with this section. 

17 Registration information shall be made publicly 

18 available by publication on the website maintained 

19 by the Food and Drug Administration, in accord20 ance with subsection (d). 

21 ‘‘(3) INSPECTION.—Each person or establish22 ment that is required to be registered with the Sec23 retary under this section shall be subject to inspec24 tion pursuant to section 704. 


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1 ‘‘(b) LISTING INFORMATION FOR IN VITRO CLINICAL

2 TESTS.— 

3 ‘‘(1) IN GENERAL.—Each person who— 

4 ‘‘(A) is a developer; and 

5 ‘‘(B) introduces or proposes to begin the 

6 introduction or delivery for introduction into 

7 interstate commerce through an exemption 

8 under subsection (a)(1), (a)(2), (a)(3), or (g) of 

9 section 587C or section 587G or through the 

10 filing of an application under section 587B or 

11 section 587D, 

12 shall submit a listing to the Secretary containing the 

13 information described in paragraph (2), (4), or (5), 

14 as applicable, in accordance with the applicable 

15 schedule described under subsection (c). Such listing 

16 shall be prepared in such form and manner as the 

17 Secretary may specify in guidance. Listing informa18 tion shall be submitted through the comprehensive 

19 test information system in accordance with section 

20 587T, as appropriate. 

21 ‘‘(2) SUBMISSIONS.—Each developer submitting 

22 a listing under paragraph (1) shall electronically 

23 submit to the comprehensive test information system 

24 described in section 587T the following information, 

25 as applicable, for each in vitro clinical test for which 


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1 such person is a developer in the form and manner 

2 prescribed by the Secretary, taking into account 

3 least burdensome principles: 

4 ‘‘(A) Name of the establishment and its es5 tablishment registration number. 

6 ‘‘(B) Contact information for the official 

7 correspondent for the listing. 

8 ‘‘(C) Name (common name and trade 

9 name, if applicable) of the in vitro clinical test 

10 and its test listing number (when available). 

11 ‘‘(D) The certificate number for any lab12 oratory certified by the Secretary under section 

13 353 of the Public Health Service Act that 

14 meets the requirements to perform high-com15 plexity testing and that is the developer of the 

16 in vitro clinical test, and the certificate number 

17 under such section for any laboratory that is 

18 performing the test, is within the same cor19 porate organization, and has common ownership 

20 by the same parent corporation. 

21 ‘‘(E) Whether the in vitro clinical test is, 

22 as applicable, offered as a test approved under 

23 section 587B, cleared to be offered under a 

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1 fered as an exempt in vitro clinical test under 

2 section 587A. 

3 ‘‘(F) Indications for use information under 

4 section 587(10). 

5 ‘‘(G) A brief summary of the analytical 

6 and clinical performance of the in vitro clinical 

7 test, and as applicable, the lot release criteria. 

8 ‘‘(H) A brief description of conformance 

9 with any applicable mitigating measures, re10 strictions, and standards. 

11 ‘‘(I) Representative labeling for the in vitro 

12 clinical test, as appropriate. 

13 ‘‘(3) TEST LISTING NUMBER.—The Secretary 

14 may assign a test listing number to each in vitro 

15 clinical test that is the subject of a listing under this 

16 section. The process for assigning test listing num17 bers may be established through guidance, and may 

18 include the recognition of standards, formats, or 

19 conventions developed by a third-party organization. 

20 ‘‘(4) ABBREVIATED LISTING.—A person who is 

21 not a developer but is otherwise required to register 

22 pursuant to subsection (a) shall submit an abbre23 viated listing to the Secretary containing the infor24 mation described in subparagraphs (A) through (C) 

25 of paragraph (2), and the name of the developer. 


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1 The information shall be submitted in accordance 

2 with the applicable schedule described under sub3 section (c). Such abbreviated listing shall be pre4 pared in such form and manner as the Secretary 

5 may specify through guidance. Listing information 

6 shall be submitted to the comprehensive test infor7 mation system in accordance with section 587T, as 

8 appropriate. 

9 ‘‘(5) GRANDFATHERED TESTS.—A developer of10 fering a test that is a grandfathered in vitro clinical 

11 test under section 587G(a) shall submit listing infor12 mation required under subparagraphs (A) through 

13 (F) of paragraph (2), and may submit a statement 

14 of the performance specifications for such in vitro 

15 clinical tests. 

16 ‘‘(6) EXEMPT TESTS.—A developer of an in 

17 vitro clinical test who introduces or proposes to 

18 begin the introduction or delivery for introduction 

19 into interstate commerce that is otherwise exempt 

20 from the requirement to submit listing information 

21 pursuant to an exemption under section 587C may 

22 submit listing information under this subsection. 

23 ‘‘(c) TIMELINES FOR SUBMISSION OF LISTING IN24 FORMATION.— 


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1 ‘‘(1) IN GENERAL.—The timelines for submis2 sion of registration and listing under subsections (a) 

3 and (b) are as follows: 

4 ‘‘(A) For an in vitro clinical test that was 

5 listed as a device under section 510(j) prior to 

6 the effective date of this section, a person shall 

7 maintain a device listing under section 510 

8 until such time as the system for submitting 

9 the listing information required under sub10 section (b) becomes available and thereafter 

11 shall submit the listing information not later 

12 than the later of 1 year after the system for 

13 submitting the listing under this section be14 comes available or the effective date of this sec15 tion. 

16 ‘‘(B) For an in vitro clinical test that is 

17 subject to grandfathering under section 

18 587G(a) a person shall submit the listing infor19 mation required under subsection (b)(5) not 

20 later that the later of 1 year after the system 

21 for submitting the listing under this section be22 comes available or the effective date of this sec23 tion. 

24 ‘‘(C) For an in vitro clinical test that is 

25 not described in subparagraph (A) or (B), a 


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1 person shall submit the required listing infor2 mation as follows: 

3 ‘‘(i) For an in vitro clinical test that 

4 is not exempt from premarket approval 

5 under section 587B, a person shall submit 

6 the required listing information, prior to 

7 offering the in vitro clinical test and not 

8 later than 30 business days after the date 

9 of approval of the premarket approval ap10 plication. 

11 ‘‘(ii) For an in vitro clinical test that 

12 is exempt from premarket review under 

13 section 587C, the required listing informa14 tion shall be submitted prior to offering 

15 the in vitro clinical test. 

16 ‘‘(2) UPDATES.— 

17 ‘‘(A) UPDATES AFTER CHANGES.—Each 

18 developer required to submit listing information 

19 under this section shall update such informa20 tion within 10 business days of any change that 

21 causes any previously listed information to be 

22 inaccurate or incomplete. 

23 ‘‘(B) ANNUAL UPDATES.—Each developer 

24 required to submit listing information under 

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1 ally during the period beginning on October 1 

2 and ending on December 31 of each year. 

3 ‘‘(d) PUBLIC AVAILABILITY OF LISTING INFORMA4 TION.— 

5 ‘‘(1) IN GENERAL.—Listing information sub6 mitted pursuant to this section shall be made pub7 licly available on the website of the Food and Drug 

8 Administration in accordance with paragraph (3). 

9 ‘‘(2) CONFIDENTIALITY.—Listing information 

10 for an in vitro clinical test that is subject to pre11 market approval or technology certification shall re12 main confidential until such date as the in vitro clin13 ical test receives the applicable premarket approval 

14 or the developer receives a technology certification 

15 order and for subsequent tests introduced under a 

16 technology certification order until their introduc17 tion. 

18 ‘‘(3) EXCEPTIONS FROM PUBLIC AVAILABILITY

19 REQUIREMENTS.—The public listing requirements of 

20 this subsection shall not apply to any registration 

21 and listing information submitted under subsection 

22 (a) or (b), if the Secretary determines that such in23 formation— 

24 ‘‘(A) is a trade secret or confidential com25 mercial information; or 


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1 ‘‘(B) if posted, would present a risk to na2 tional security. 

3 ‘‘(e) SUBMISSION OF INFORMATION BY ACCREDITED

4 PERSONS.—If agreed upon by the developer, the informa5 tion required under this section may be submitted by a 

6 person accredited under section 587Q. 

7 ‘‘SEC. 587K. TEST DESIGN AND QUALITY REQUIREMENTS. 

8 ‘‘(a) APPLICABILITY.— 

9 ‘‘(1) IN GENERAL.—Each developer and each 

10 other person required to register under section 

11 587I(b)(1) shall establish and maintain quality re12 quirements in accordance with the applicable re13 quirements set forth in subsection (b). 

14 ‘‘(2) CERTIFIED LABORATORY REQUIRE15 MENTS.—A developer shall establish and maintain 

16 quality requirement under subsection (b)(2) or 

17 (b)(3), as applicable, if such developer is a clinical 

18 laboratory certified by the Secretary under section 

19 353 of the Public Health Service Act that— 

20 ‘‘(A) is certified to perform high-com21 plexity testing; 

22 ‘‘(B) develops an in vitro clinical test that 

23 is for use only— 


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1 ‘‘(i) within the laboratory certified by 

2 the Secretary under such section 353 in 

3 which such test was developed; or 

4 ‘‘(ii) within another laboratory cer5 tified by the Secretary under such section 

6 353 if such laboratory is— 

7 ‘‘(I) within the same corporate 

8 organization and has common owner9 ship by the same parent corporation 

10 as the laboratory in which the test 

11 was developed; or 

12 ‘‘(II) within a public health lab13 oratory network coordinated or man14 aged by the Centers for Disease Con15 trol and Prevention, if the test is de16 veloped by a public health laboratory 

17 or the Centers for Disease Control 

18 and Prevention; and 

19 ‘‘(C) does not manufacture, produce, or 

20 distribute in vitro clinical tests other than lab21 oratory test protocols. 

22 ‘‘(3) REGULATIONS.—The Secretary shall pro23 mulgate quality system regulations implementing 

24 this section. In promulgating such regulations under 

25 this section, the Secretary shall consider whether, 


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1 and to what extent, international harmonization is 

2 appropriate. 

3 ‘‘(4) QUALITY SYSTEMS FOR HYBRID DEVEL4 OPERS OF BOTH LABORATORY TEST PROTOCOLS AND

5 OTHER IN VITRO CLINICAL TESTS.—An entity that 

6 develops both finished products and laboratory test 

7 protocols and other in vitro clinical tests shall com8 ply with subsection (b)(1) for activities related to the 

9 development of any in vitro clinical test that is not 

10 a laboratory test protocol product and with sub11 section (b)(2) or (b)(3), as applicable, for activities 

12 related to the development of any laboratory test 

13 protocol. 

14 ‘‘(b) QUALITY REQUIREMENTS.— 

15 ‘‘(1) IN GENERAL.—The quality requirements 

16 applicable under this section shall— 

17 ‘‘(A) avoid duplication of regulations under 

18 section 353 of the Public Health Service Act; 

19 and 

20 ‘‘(B) shall include the following, as applica21 ble, subject to subparagraph (A) and para22 graphs (2) and (3)— 

23 ‘‘(i) management responsibilities; 

24 ‘‘(ii) quality audits; 

25 ‘‘(iii) personnel; 


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1 ‘‘(iv) design controls; 

2 ‘‘(v) document controls; 

3 ‘‘(vi) purchasing controls; 

4 ‘‘(vii) identification and traceability; 

5 ‘‘(viii) production and process con6 trols; 

7 ‘‘(ix) acceptance activities; 

8 ‘‘(x) nonconforming in vitro clinical 

9 tests; 

10 ‘‘(xi) corrective and preventive action; 

11 ‘‘(xii) labeling and packaging controls; 

12 ‘‘(xiii) handling, storage, distribution, 

13 and installation; 

14 ‘‘(xiv) complaints and records; 

15 ‘‘(xv) servicing; and 

16 ‘‘(xvi) statistical techniques. 

17 ‘‘(2) EXCEPTION FOR LABORATORY TEST PRO18 TOCOLS.—Developers that are developing test proto19 cols for use as described in subsection (a)(2)(B)(i) 

20 are exempt from the requirements under paragraph 

21 (1)(B) except for the requirements described in 

22 clauses (iv), (vi), (ix), (xi), and (xiv) of such para23 graph. 

24 ‘‘(3) QUALITY REQUIREMENTS FOR CERTAIN

25 LABORATORIES DISTRIBUTING LABORATORY TEST


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1 PROTOCOLS WITHIN ORGANIZATIONS OR PUBLIC

2 HEALTH NETWORKS.—Quality requirements applica3 ble to the developer who is distributing a laboratory 

4 test protocol as described in subsection (a)(2)(B)(ii) 

5 shall consist of the following: 

6 ‘‘(A) Clauses (iv), (vi), (ix), (xi), (xiv), (xii) 

7 of paragraph (1)(B). 

8 ‘‘(B) The requirement to maintain records 

9 of the laboratories to which the laboratory test 

10 protocol is distributed. 

11 ‘‘(c) REGULATIONS.—In implementing quality re12 quirements for test developers that participate in inter13 national audit programs under this section, the Secretary 

14 shall— 

15 ‘‘(1) for purposes of facilitating international 

16 harmonization, consider whether the developer par17 ticipates in an international audit program in which 

18 the United States participates and recognizes com19 pliance with, or conformance to, such standards rec20 ognized by the Secretary; and 

21 ‘‘(2) ensure a least burdensome approach de22 scribed in section 587AA(c) by leveraging, to the ex23 tent applicable, the quality assurance requirements 

24 applicable to developers certified by the Secretary 

25 under section 353 of the Public Health Service Act. 


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1 ‘‘SEC. 587L. LABELING REQUIREMENTS. 

2 ‘‘(a) IN GENERAL.—An in vitro clinical test shall 

3 bear or be accompanied by labeling, as applicable, that 

4 meets the requirements set forth in subsections (b) and 

5 (c), unless such test is exempt under subsection (d) or (e). 

6 ‘‘(b) LABELS.— 

7 ‘‘(1) IN GENERAL.—The label of an in vitro 

8 clinical test, shall meet the requirements set forth in 

9 paragraph (2) if there is an immediate container to 

10 which the label is applied. 

11 ‘‘(2) REGULATIONS.—The label of an in vitro 

12 clinical test shall state the name and place of busi13 ness of its developer and meet the requirements set 

14 forth in regulations promulgated in accordance with 

15 this section. 

16 ‘‘(c) LABELING.— 

17 ‘‘(1) IN GENERAL.—Labeling of an in vitro clin18 ical test, including labeling in the form of a package 

19 insert, website, standalone laboratory reference docu20 ment, or other similar document shall include— 

21 ‘‘(A) adequate directions for use and shall 

22 meet the requirements set forth in regulations 

23 promulgated under this section, except as pro24 vided in subsection (d) or (e); and 

25 ‘‘(B) the information described in para26 graph (2), as applicable. 


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1 ‘‘(2) CONTENT.—Labeling of an in vitro clinical 

2 test shall include— 

3 ‘‘(A) the test listing number that was pro4 vided to the developer at the time of listing; 

5 ‘‘(B) information to facilitate reporting an 

6 adverse event; 

7 ‘‘(C) information regarding accessing the 

8 performance summary data displayed in the 

9 listing database for the test; 

10 ‘‘(D) the indications of use of the in vitro 

11 clinical test; and 

12 ‘‘(E) any warnings, contraindications, or 

13 limitations. 

14 ‘‘(3) PUBLIC AVAILABILITY OF INFORMATION.— 

15 The Secretary shall make all of the information de16 scribed in paragraph (2) with respect to each in 

17 vitro clinical test available to the public, as applica18 ble, in accordance with section 587T, except to the 

19 extent that the Secretary determines that such infor20 mation— 

21 ‘‘(A) is trade secret or confidential com22 mercial information; or 

23 ‘‘(B) if posted, would present a risk to na24 tional security. 


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1 ‘‘(4) ADDITIONAL REQUIREMENTS.—Labeling 

2 for an in vitro clinical test used for 

3 immunohematology testing shall meet the applicable 

4 requirements set forth in part 660 of title 21, Code 

5 of Federal Regulations (or any successor regula6 tions), related to the labeling of blood grouping re7 agents, reagent red blood cells, and anti-human 

8 globulin. 

9 ‘‘(d) EXEMPTIONS AND ALTERNATIVE REQUIRE10 MENTS.— 

11 ‘‘(1) IN GENERAL.— 

12 ‘‘(A) IN GENERAL.—With respect to an in 

13 vitro clinical test that meets the criteria of sub14 paragraph (B), the ‘state in one place’ regula15 tions under section 809.10(b) of title 21, Code 

16 of Federal Regulations (or any successor regu17 lations) may be satisfied by the laboratory post18 ing such information on its website or in mul19 tiple documents, if such documents are main20 tained and accessible in one place. 

21 ‘‘(B) APPLICABLE TESTS.—An in vitro 

22 clinical test meets the criteria of this subpara23 graph if such test is— 

24 ‘‘(i) developed by a laboratory cer25 tified by the Secretary under section 353 


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1 of the Public Health Service Act that 

2 meets the requirements to perform tests of 

3 high-complexity; and 

4 ‘‘(ii) performed in— 

5 ‘‘(I) the same laboratory in which 

6 such test was developed; or 

7 ‘‘(II) by another laboratory cer8 tified by the Secretary under section 

9 353 of the Public Health Service Act 

10 that— 

11 ‘‘(aa) meets the require12 ments to perform tests of high 

13 complexity; and 

14 ‘‘(bb) is under common own15 ership and control as the labora16 tory that developed the test. 

17 ‘‘(2) TEST INSTRUMENT LABELING.—Unless 

18 the instrument is the entire test system, the labeling 

19 for an instrument is not required to bear the infor20 mation indicated in paragraphs (3), (4), (5), (7), 

21 (8), (9), (10), (11), (12), and (13) of section 

22 809.10(b) of title 21, Code of Federal Regulations 

23 (or any successor regulations). 

24 ‘‘(3) REAGENT LABELING.—For purposes of 

25 compliance with subsection (c)(1), the labeling for a 


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1 reagent intended for use as a replacement in an in 

2 vitro clinical test may be limited to that information 

3 necessary to identify the reagent adequately and to 

4 describe its proper use in the test. 

5 ‘‘(4) INVESTIGATIONAL USE.—A shipment or 

6 other delivery of an in vitro clinical test for inves7 tigational use pursuant to section 587S shall be ex8 empt from the labeling requirements of subsections 

9 (b) and (c)(1) and from any standard promulgated 

10 through regulations, except as required under sec11 tion 353 of the Public Health Service Act or section 

12 587R of this Act. 

13 ‘‘(5) GENERAL PURPOSE LABORATORY RE14 AGENTS.—The labeling of general purpose labora15 tory reagents (such as hydrochloric acid) whose uses 

16 are generally known by persons trained in their use 

17 need not bear the directions for use required by sub18 section (c)(1)(A). 

19 ‘‘(6) OVER-THE-COUNTER TEST SPECIMEN RE20 CEPTACLE LABELING.—The labeling for over-the21 counter test specimen receptacles for drugs of abuse 

22 testing shall bear the name and place of business of 

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1 ble regulations promulgated under this section, in 

2 language appropriate for the intended users. 

3 ‘‘(e) TESTS IN THE STRATEGIC NATIONAL STOCK4 PILE.— 

5 ‘‘(1) IN GENERAL.—The Secretary may grant 

6 an exception or alternative to any provision listed in 

7 this section, unless explicitly required by a statutory 

8 provision outside this subchapter, for specified lots, 

9 batches, or other units of an in vitro clinical test, if 

10 the Secretary determines that compliance with such 

11 labeling requirement could adversely affect the avail12 ability of such products that are, or will be, included 

13 in the Strategic National Stockpile under section 

14 319F–2 of the Public Health Service Act. 

15 ‘‘(2) REGULATIONS.—The Secretary may issue 

16 regulations amending section 809.11 of title 21, 

17 Code of Federal Regulations (or any successor regu18 lation) to apply in full or in part to in vitro clinical 

19 tests and in vitro clinical test developers. 

20 ‘‘(f) REGULATIONS.—The Secretary shall issue or re21 vise regulations related to standardized, general content 

22 and format for in vitro clinical test labeling pursuant to 

23 this subsection. 


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1 ‘‘SEC. 587M. ADVERSE EVENT REPORTING. 

2 ‘‘(a) IN GENERAL.—Each in vitro clinical test devel3 oper shall establish and maintain a system for establishing 

4 and maintaining records of adverse events and reporting 

5 adverse events in accordance with this section. 

6 ‘‘(b) SUBMISSION OF INDIVIDUAL REPORTS.—A de7 veloper shall submit an individual adverse event not later 

8 than 5 calendar days after the developer receives or be9 comes aware of an adverse event that reasonably suggests 

10 that an in vitro clinical test may— 

11 ‘‘(1) have caused or contributed to a patient or 

12 user death; or 

13 ‘‘(2) present an imminent threat to public 

14 health. 

15 ‘‘(c) SUBMISSION OF QUARTERLY REPORTS.—As ap16 plicable, a developer shall submit quarterly reports that 

17 include any in vitro clinical test errors and serious injuries 

18 that occurred during the applicable quarter. Such quar19 terly reports shall be submitted not later than the end of 

20 the quarter following the quarter in which the developer 

21 receives or becomes aware of such adverse events. 

22 ‘‘(d) DEFINITIONS.—For the purposes of this sec23 tion— 

24 ‘‘(1) the term ‘in vitro clinical test error’ means 

25 a failure of an in vitro clinical test to meet its per26 formance specifications, or to otherwise perform as 


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1 intended by the developer, including an inaccurate 

2 result resulting from such failure; and 

3 ‘‘(2) the term ‘serious injury’ means— 

4 ‘‘(A) a significant delay in a diagnosis that 

5 results in the absence, delay, or discontinuation 

6 of critical medical treatment or that irreversibly 

7 or seriously and negatively alters the course of 

8 a disease or condition; or 

9 ‘‘(B) an injury that— 

10 ‘‘(i) is life threatening; 

11 ‘‘(ii) results in permanent impairment 

12 of a body function or permanent damage 

13 to a body structure; or 

14 ‘‘(iii) necessitates medical or surgical 

15 intervention to preclude permanent impair16 ment of a body function or permanent 

17 damage to a body structure. 

18 ‘‘(e) REGULATIONS.—The Secretary shall promulgate 

19 regulations to implement this section. 

20 ‘‘SEC. 587N. CORRECTIONS AND REMOVALS. 

21 ‘‘(a) REGULATIONS.—The Secretary shall promulgate 

22 regulations, or amend existing regulations, as appropriate, 

23 to implement this section. 

24 ‘‘(b) REPORTS OF CORRECTIONS AND REMOVALS.— 


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1 ‘‘(1) IN GENERAL.—Each in vitro clinical test 

2 developer shall report to the Secretary any correc3 tion or removal of an in vitro clinical test under4 taken by such developer if the correction or removal 

5 was undertaken— 

6 ‘‘(A) to reduce the risk to health posed by 

7 the in vitro clinical test; or 

8 ‘‘(B) to remedy a violation of this Act 

9 caused by the in vitro clinical test which may 

10 present a risk to health. 

11 ‘‘(2) EXCEPTION FOR IN VITRO CLINICAL TESTS

12 OFFERED UNDER A TECHNOLOGY CERTIFICATION

13 ORDER.—For any eligible test offered under a tech14 nology certification order under section 587D, a cor15 rection and removal report for any correction or re16 moval of an in vitro clinical test should demonstrate 

17 that the issue or issues causing the correction or re18 moval do not adversely impact the ability of other in 

19 vitro clinical tests offered under the same technology 

20 certification order to meet the applicable standard. 

21 ‘‘(c) TIMING.—A developer shall submit any report 

22 required under this subsection to the Secretary within 15 

23 business days of initiating such correction or removal. 

24 ‘‘(d) RECORDKEEPING.—A developer of an in vitro 

25 clinical test that undertakes a correction or removal of an 


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1 in vitro clinical test which is not required to be reported 

2 under this subsection shall keep a record of such correc3 tion or removal. 

4 ‘‘(e) RECALL COMMUNICATIONS.—Upon the vol5 untary reporting of a correction or removal by the devel6 oper— 

7 ‘‘(1) the Secretary shall classify such correction 

8 or removal under this section within 15 calendar 

9 days; and 

10 ‘‘(2) not later than 45 calendar days after the 

11 developer or other responsible party notifies the Sec12 retary that it has completed a recall action, the Sec13 retary shall provide the developer or other respon14 sible party with a written statement closing the re15 call action or stating the reasons the Secretary can16 not close the recall at that time. 

17 ‘‘SEC. 587O. RESTRICTED IN VITRO CLINICAL TESTS. 

18 ‘‘(a) APPLICABILITY.— 

19 ‘‘(1) IN GENERAL.—For the types of in vitro 

20 clinical tests described in paragraph (3) the Sec21 retary may require, in issuing an approval of an in 

22 vitro clinical test under section 587B, granting a 

23 technology certification order under section 587D, or 

24 in issuing a determination under section 587F(a), or 

25 by issuing a regulation, that such test, or category 


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1 of tests, be restricted to sale, distribution, or use 

2 upon such conditions as the Secretary may prescribe 

3 under paragraph (2). 

4 ‘‘(2) CONDITIONS.— The Secretary may pre5 scribe conditions under this section, based on avail6 able evidence, with respect to an in vitro clinical test 

7 described in paragraph (3), that are determined to 

8 be needed due to the potential for harmful effect of 

9 such test (including any resulting absence, signifi10 cant delay, or discontinuation of appropriate medical 

11 treatment), and are necessary to ensure that the test 

12 meets the applicable standard. 

13 ‘‘(3) IN VITRO CLINICAL TESTS SUBJECT TO

14 RESTRICTIONS.—The restrictions or conditions au15 thorized under this section may be applied by the 

16 Secretary to any high-risk or moderate-risk in vitro 

17 clinical test, prescription home-use in vitro clinical 

18 test, direct-to-consumer in vitro clinical test, or over19 the-counter in vitro clinical test. 

20 ‘‘(b) LABELING AND ADVERTISING OF A RESTRICTED

21 IN VITRO CLINICAL TEST.—The labeling and advertising 

22 of an in vitro clinical test to which restrictions apply under 

23 subsection (a) shall bear such appropriate statements of 

24 the restrictions as the Secretary may prescribe in an ap25 proval under section 587B, an order under section 587D, 


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1 a determination under section 587F(a), or in regulation, 

2 as applicable. 

3 ‘‘(c) DEVICE RESTRICTIONS.—An in vitro clinical 

4 test that was offered as a restricted device prior to the 

5 date of enactment of this subchapter— 

6 ‘‘(1) shall continue to comply with the applica7 ble restrictions under section 515 or section 520(e) 

8 until the this subchapter takes effect; and 

9 ‘‘(2) except for in vitro clinical tests required to 

10 meet section 809.30 of title 21, Code of Federal 

11 Regulations prior to the effective date of this sub12 chapter specified in section 825(a)(1)(A) of the 

13 VALID Act of 2022, such restrictions shall be 

14 deemed to be restrictions under this Act as of such 

15 effective date. 

16 ‘‘SEC. 587P. APPEALS. 

17 ‘‘(a) SIGNIFICANT DECISION.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall main19 tain a substantive summary of the scientific and reg20 ulatory rationale for any significant decision of the 

21 Food and Drug Administration pursuant to section 

22 587F, regarding— 

23 ‘‘(A) the submission of an application for, 

24 or a review of, an in vitro clinical test under 

25 section 587B or section 587D; 


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1 ‘‘(B) an exemption under section 587C; or 

2 ‘‘(C) any requirements for mitigation 

3 measures to an in vitro clinical test or category 

4 of in vitro clinical tests. 

5 Such summaries shall include documentation of sig6 nificant controversies or differences of opinion and 

7 the resolution of such controversies or differences of 

8 opinion. 

9 ‘‘(2) PROVISION OF DOCUMENTATION.—Upon 

10 request, the Secretary shall furnish a substantive 

11 summary described in paragraph (1) to the person 

12 who has made, or is seeking to make, a submission 

13 described in such paragraph. 

14 ‘‘(3) APPLICATION OF LEAST BURDENSOME RE15 QUIREMENTS.—The substantive summary required 

16 under this subsection shall include a brief statement 

17 regarding how the least burdensome requirements 

18 were considered and applied consistent with section 

19 587AA(c), as applicable. 

20 ‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 

21 ‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF

22 SIGNIFICANT DECISION.—A developer may request a 

23 supervisory review of the significant decision de24 scribed in subsection (a)(1). Such review may be 

25 conducted at the next supervisory level or higher 


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1 above the agency official who made the significant 

2 decision. 

3 ‘‘(2) SUBMISSION OF REQUEST.—A developer 

4 requesting a supervisory review under paragraph (1) 

5 shall submit such request to the Secretary not later 

6 than 30 days after the decision for which the review 

7 is requested and shall indicate in the request wheth8 er such developer seeks an in-person meeting or a 

9 teleconference review. 

10 ‘‘(3) TIMEFRAME.—The Secretary shall sched11 ule an in-person or teleconference review, if so re12 quested, not later than 30 days after such request 

13 is made. The Secretary shall issue a decision to the 

14 developer requesting a review under this subsection 

15 not later than 45 days after the request is made 

16 under paragraph (1), or, in the case of a developer 

17 who requests an in-person meeting or teleconference, 

18 30 days after such meeting or teleconference. 

19 ‘‘(c) ADVISORY PANELS.—The process established 

20 under subsection (a) shall permit the appellant to request 

21 review by an advisory committee established under section 

22 587G when there is a dispute involving substantial sci23 entific fact. If an advisory panel meeting is held, the Sec24 retary shall make a determination under this subsection 


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1 not later than 45 days after the requested advisory com2 mittee meeting has concluded. 

3 ‘‘(d) LEAST BURDENSOME REVIEW.—Any developer 

4 who has submitted an application under section 587B or 

5 587D may request a supervisory review of a request for 

6 additional information during an evaluation of such sub7 mission within 60 calendar days of receipt of the addi8 tional information request from the Secretary. 

9 ‘‘(e) AVAILABILITY OF ALL REMEDIES.—The proce10 dures set forth in this section shall be in addition to, and 

11 not in lieu of, other remedies available to the developer. 

12 ‘‘SEC. 587Q. ACCREDITED PERSONS. 

13 ‘‘(a) IN GENERAL.— 

14 ‘‘(1) AUTHORIZATION.—Beginning on the date 

15 of enactment of the VALID Act of 2022, the Sec16 retary shall accredit persons for any of the following 

17 purposes: 

18 ‘‘(A) Reviewing applications for premarket 

19 approval under section 587B and making find20 ings with respect to such applications. 

21 ‘‘(B) Reviewing applications for technology 

22 certification under section 587D and making 

23 recommendations to the Secretary with respect 

24 to such applications. 


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1 ‘‘(C) Conducting inspections as specified in 

2 subsection (c) of in vitro clinical test developers 

3 and other persons required to register pursuant 

4 to section 587I. 

5 ‘‘(2) PERSONS SUBMITTING APPLICATIONS.—A 

6 person submitting an application for premarket ap7 proval under section 587B or an application for 

8 technology certification under section 587D may 

9 submit such application to the Secretary or to a per10 son accredited pursuant to subparagraph (A) or (B) 

11 of paragraph (1). 

12 ‘‘(b) ACCREDITED PERSONS APPLICATION REVIEWS, 

13 FINDINGS AND RECOMMENDATIONS.— 

14 ‘‘(1) REQUIREMENTS FOR PREMARKET APPLI15 CATION.— 

16 ‘‘(A) REVIEW AND FINDING REQUIRE17 MENTS.—An accredited person receiving an ap18 plication for premarket approval under section 

19 587B shall either— 

20 ‘‘(i) provide to the Secretary, together 

21 with the application for premarket ap22 proval submitted by the applicant, a find23 ing that the criteria for approval of the ap24 plication under section 587B(g)(2)(A) are 

25 met and issue a copy of such finding to the 


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1 applicant, which finding shall plainly 

2 state— 

3 ‘‘(I) the basis for the accredited 

4 person’s finding that the criteria 

5 under section 587B(g)(2)(A) are met; 

6 and 

7 ‘‘(II) any proposed restrictions, 

8 mitigating measures, or conditions of 

9 approval under section 

10 587B(g)(2)(B), as applicable; or 

11 ‘‘(ii) provide a notification to the ap12 plicant that the accredited person cannot 

13 find that the criteria for approval of the 

14 application under section 587B(g)(2)(A) 

15 are met and the reasons for such decision. 

16 ‘‘(B) REQUESTING MISSING OR CLARI17 FYING INFORMATION.—After receipt of an ap18 plication under this section, the Secretary may 

19 request missing or clarifying information from 

20 the applicant concerning the application, which 

21 the applicant shall promptly provide. 

22 ‘‘(C) SECRETARY ACTION ON FINDING

23 THAT APPROVAL CRITERIA ARE MET.—If the 

24 accredited person transmits a finding to the 

25 Secretary under clause (i) of subparagraph (A), 


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1 then prior to the date that is 45 calendar days 

2 after the transmittal date the Secretary shall— 

3 ‘‘(i) approve the application for pre4 market approval under section 587B(g)(2) 

5 with appropriate restrictions, mitigating 

6 measures, or conditions of approval, as ap7 plicable; or 

8 ‘‘(ii) deny approval of the application 

9 by issuing a written notice that reflects ap10 propriate management input and concur11 rence to the accredited person and the ap12 plicant detailing the scientific basis for the 

13 Secretary’s determination that the criteria 

14 for issuance of an approval under section 

15 587B(g)(2)(A) have not been met. 

16 ‘‘(D) EFFECT OF INACTION ON FINDING.— 

17 If the Secretary fails to take an action under 

18 subparagraph (C) the Secretary shall— 

19 ‘‘(i) within 45 calendar days after the 

20 transmittal date, provide written feedback 

21 to the applicant that— 

22 ‘‘(I) includes all outstanding 

23 issues with the application preventing 

24 the Secretary from taking an action 

25 under subparagraph (B); 


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1 ‘‘(II) reflects appropriate man2 agement input and concurrence; and 

3 ‘‘(III) includes action items for 

4 the Secretary, the applicant, or both, 

5 as appropriate, with an estimated date 

6 of completion for the Secretary and 

7 the applicant to complete their respec8 tive tasks, as applicable; and 

9 ‘‘(ii) promptly schedule a meeting or 

10 teleconference to discuss the feedback pro11 vided under clause (i), unless the Secretary 

12 and applicant agree that the outstanding 

13 issues are adequately presented through 

14 written correspondence and a meeting or 

15 teleconference is not necessary. 

16 ‘‘(2) REQUIREMENTS FOR TECHNOLOGY CER17 TIFICATION.— 

18 ‘‘(A) REVIEW AND RECOMMENDATION RE19 QUIREMENTS.—An accredited person receiving 

20 an application for technology certification under 

21 section 587D shall either— 

22 ‘‘(i) provide to the Secretary, together 

23 with the application for technology certifi24 cation submitted by the applicant, a rec25 ommendation that the criteria for issuance 


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1 of a technology certification order under 

2 section 587D(f)(3) are met and issue a 

3 copy of such recommendation to the appli4 cant, which recommendation shall plainly 

5 state the basis for the accredited person’s 

6 recommendation that the criteria under 

7 section 587D(f)(3) are met; or 

8 ‘‘(ii) provide a notification to the ap9 plicant that the accredited person cannot 

10 recommend that the criteria for issuance of 

11 a technology certification order under sec12 tion 587D(f)(3) are met and the reasons 

13 for such decision. 

14 ‘‘(B) REQUESTING MISSING OR CLARI15 FYING INFORMATION.—After receipt of an ap16 plication under this section, the Secretary may 

17 request missing or clarifying information from 

18 the applicant concerning the application, which 

19 the applicant shall promptly provide. 

20 ‘‘(C) SECRETARY ACTION ON REC21 OMMENDATION FOR ISSUANCE OF A TECH22 NOLOGY CERTIFICATION ORDER.—If the accred23 ited person transmits a recommendation to the 

24 Secretary under clause (i) of subparagraph (A), 


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1 then prior to the date that is 60 calendar days 

2 after the transmittal date the Secretary shall— 

3 ‘‘(i) issue the technology certification 

4 order under section 587D(f)(3), consistent 

5 with such recommendation from the ac6 credited person; or 

7 ‘‘(ii) deny approval of the application 

8 by issuing a written notice to the accred9 ited person and the applicant detailing the 

10 scientific basis for a determination by the 

11 Secretary that the criteria for issuance of 

12 a technology certification order under sec13 tion 587D(f)(3) have not been met. 

14 ‘‘(c) REQUIREMENTS FOR INSPECTIONS.— 

15 ‘‘(1) IN GENERAL.—When conducting inspec16 tion, persons accredited under subparagraph 

17 (a)(1)(B) shall record in writing their specific obser18 vations and shall present their observations to the 

19 designated representative of the inspected establish20 ment. 

21 ‘‘(2) INSPECTION REPORT REQUIREMENTS.— 

22 Each person accredited under this subparagraph 

23 (a)(1)(C) shall prepare and submit to the Secretary 

24 an inspection report in a form and manner des25 ignated by the Secretary for conducting inspections. 


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1 Any statement or representation made by an em2 ployee or agent of an establishment to a person ac3 credited to conduct inspections under subparagraph 

4 (a)(1)(C) shall be subject to section 1001 of title 18, 

5 United States Code. 

6 ‘‘(3) SAVINGS CLAUSE.—Nothing in this section 

7 affects the authority of the Secretary to inspect any 

8 in vitro clinical test developer or other person reg9 istered under section 587I or recognize inspections 

10 conducted by auditing organizations as described 

11 under section 704(g)(15). 

12 ‘‘(4) INSPECTION LIMITATIONS.—The Secretary 

13 shall ensure that inspections carried out under this 

14 section are not duplicative of inspections carried out 

15 under section 353 of the Public Health Service Act. 

16 Inspections under this section shall be limited to the 

17 data and information necessary— 

18 ‘‘(A) for routine surveillance activities of 

19 facilities associated with an approved applica20 tion under section 587B or issuance of a tech21 nology certification order under section 587D; 

22 or 

23 ‘‘(B) to meet the requirements for pre24 market approval under section 587B or 


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1 issuance of a technology certification order 

2 under section 587D, as applicable. 

3 ‘‘(d) ACCREDITATION.— 

4 ‘‘(1) ACCREDITATION PROGRAM.—The Sec5 retary may provide for accreditation under this sec6 tion through programs administered by the Food 

7 and Drug Administration, by other non-Federal gov8 ernment agencies, or by qualified nongovernmental 

9 organizations. A person may be accredited for the 

10 review of applications submitted under sections 

11 587B as described in subsection (a)(1)(A), for the 

12 review of applications submitted under section 587D 

13 as described in subsection (a)(1)(B) and to conduct 

14 inspection activities under subsection (a)(1)(C), or 

15 for a subset of such reviews or activities. 

16 ‘‘(2) ELIGIBLE PERSONS.— 

17 ‘‘(A) MINIMUM QUALIFICATIONS.—An ac18 credited person, at a minimum, shall— 

19 ‘‘(i) not be an employee of the Federal 

20 Government; 

21 ‘‘(ii) not engage in the activities of a 

22 developer, as defined in section 587(7); 

23 ‘‘(iii) not be a person required to reg24 ister under section 587I, unless such per25 son has established sufficient processes 


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1 and protocols to separate activities to de2 velop in vitro clinical tests and the activi3 ties for which such person would be ac4 credited under subsection (a) and discloses 

5 applicable information under this section; 

6 ‘‘(iv) not be owned or controlled by, 

7 and shall have no organizational, material, 

8 or financial affiliation with, an in vitro 

9 clinical test developer or other person re10 quired to register under section 587I; 

11 ‘‘(v) be a legally constituted entity 

12 permitted to conduct the activities for 

13 which it seeks accreditation; 

14 ‘‘(vi) ensure that the operations of 

15 such person are in accordance with gen16 erally accepted professional and ethical 

17 business practices; and 

18 ‘‘(vii) include in its request for accred19 itation a commitment to, at the time of ac20 creditation and at any time it is per21 forming activities pursuant to this sec22 tion— 

23 ‘‘(I) certify that the information 

24 reported to the Secretary accurately 

25 reflects the data or protocol reviewed, 


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1 and the documented inspection find2 ings, as applicable; 

3 ‘‘(II) limit work to that for which 

4 competence and capacity are available; 

5 ‘‘(III) treat information received 

6 or learned, records, reports, and rec7 ommendations as proprietary informa8 tion of the person submitting such in9 formation; and 

10 ‘‘(IV) in conducting the activities 

11 for which the person is accredited in 

12 respect to a particular in vitro clinical 

13 test, protect against the use of any 

14 employee or consultant who has a fi15 nancial conflict of interest regarding 

16 that in vitro clinical test. 

17 ‘‘(B) WAIVER.—The Secretary may waive 

18 any requirements in clauses (i), (ii), (iii), or (iv) 

19 of subparagraph (A) upon making a determina20 tion that such person has implemented other 

21 appropriate controls sufficient to ensure a com22 petent and impartial review. 

23 ‘‘(3) ACCREDITATION PROCESS.— 

24 ‘‘(A) ACCREDITATION PROCESS GUIDANCE

25 AND REGULATIONS.—Not later than 180 days 


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1 after the date of enactment of the VALID Act 

2 of 2022, the Secretary shall issue draft guid3 ance specifying the process for submitting a re4 quest for accreditation and reaccreditation 

5 under this section, including the form and con6 tent of information to be submitted, including 

7 the criteria that the Secretary will consider to 

8 accredit or deny accreditation and, not later 

9 than 1 year after the close of the comment pe10 riod for the draft guidance, issue final guid11 ance. 

12 ‘‘(B) RESPONSE TO REQUEST.—The Sec13 retary shall respond to a request for accredita14 tion or reaccreditation within 60 calendar days 

15 of the receipt of the request. The Secretary’s 

16 response may be to accredit or reaccredit the 

17 person, to deny accreditation, or to request ad18 ditional information in support of the request. 

19 If the Secretary requests additional informa20 tion, the Secretary shall respond within 60 cal21 endar days of receipt of such additional infor22 mation to accredit or deny the accreditation. 

23 ‘‘(C) TYPE OF ACCREDITATION.—The ac24 creditation or reaccreditation of a person shall 

25 specify the particular activity or activities under 


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1 subsection (a) for which such person is accred2 ited, and shall include any limitation to certain 

3 eligible in vitro clinical tests. 

4 ‘‘(D) PUBLIC LIST.—The Secretary shall 

5 publish on the website of the Food and Drug 

6 Administration a list of persons who are accred7 ited under this section. Such list shall be up8 dated on at least a monthly basis. The list shall 

9 specify the particular activity or activities under 

10 this section for which the person is accredited. 

11 ‘‘(E) AUDIT.—The Secretary may audit 

12 the performance of persons accredited under 

13 this section for purposes of ensuring that such 

14 persons continue to meet the published criteria 

15 for accreditation, and may modify the scope or 

16 particular activities for which a person is ac17 credited if the Secretary determines that such 

18 person fails to meet one or more criteria for ac19 creditation. 

20 ‘‘(F) SUSPENSION OR WITHDRAWAL.—The 

21 Secretary may suspend or withdraw accredita22 tion of any person accredited under this section, 

23 after providing notice and an opportunity for an 

24 informal hearing, when such person is substan25 tially not in compliance with the requirements 


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1 of this section or the published criteria for ac2 creditation, or poses a threat to public health, 

3 or fails to act in a manner that is consistent 

4 with the purposes of this section. 

5 ‘‘(G) REACCREDITATION.—Accredited per6 sons may be initially accredited for up to 3 

7 years. After expiration of such initial period, 

8 persons may be reaccredited for unlimited addi9 tional 35-year periods, as determined by the 

10 Secretary. 

11 ‘‘(e) COMPENSATION OF ACCREDITED PERSONS.— 

12 Compensation of an accredited person shall be determined 

13 by agreement between the accredited person and the per14 son who engages the services of the accredited person, and 

15 shall be paid by the person who engages such services. 

16 ‘‘(f) INTERNATIONAL HARMONIZATION.—Notwith17 standing any other provision of this section, to facilitate 

18 international harmonization the Secretary may recognize 

19 persons accredited or recognized by governments, who 

20 have also entered into information sharing agreements, in21 cluding confidentiality commitments, with the Commis22 sioner of Food and Drugs. 

23 ‘‘(g) INFORMATION SHARING AGREEMENTS.—An ac24 credited person may enter into an agreement with a test 

25 developer to provide information to the comprehensive test 


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1 information system under section 587T, including any re2 quirements under section 587I. 

3 ‘‘(h) REPORTS.—Not later than 2 years after the ef4 fective date of the VALID Act of 2022, and annually 

5 thereafter for the next 4 years, the Secretary shall post 

6 on the website of the Food and Drug Administration, a 

7 report describing the Secretary’s performance in imple8 menting this section, including the Secretary’s progress in 

9 minimizing duplicative reviews of applications for which 

10 an accredited person finds the criteria for approval are 

11 met. Such reports shall include, for each period— 

12 ‘‘(1) with regard to premarket approval applica13 tions— 

14 ‘‘(A) the total number of findings trans15 mitted to the Secretary under subsection 

16 (b)(1)(A)(i); 

17 ‘‘(B) the total number of determinations 

18 made by the Secretary under subsection 

19 (b)(1)(B)(i) within 30 calendar days of the 

20 transmittal date to approve an application; 

21 ‘‘(C) the total number of determinations 

22 made by the Secretary under subsection 

23 (b)(1)(B)(ii) within 30 calendar days of the 

24 transmittal date to deny approval of an applica25 tion; and 


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1 ‘‘(D) the total number of applications that 

2 were approved and the total number of applica3 tions that were denied approval, after the Sec4 retary failed to make a determination within 30 

5 calendar days of the transmittal date under 

6 subsection (b)(1)(B); and 

7 ‘‘(2) with regard to applications for technology 

8 certification— 

9 ‘‘(A) the total number of recommendations 

10 transmitted to the Secretary under subsection 

11 (b)(2)(A)(i); 

12 ‘‘(B) the total number of determinations 

13 made by the Secretary under subsection 

14 (b)(2)(B)(i) to issue a technology certification 

15 order, including determinations made within 30 

16 days of the transmittal date; 

17 ‘‘(C) the total number of determinations 

18 made by the Secretary under subsection 

19 (b)(2)(B)(ii) to deny the application for tech20 nology certification, including determinations 

21 made within 30 calendar days of the trans22 mittal date; and 

23 ‘‘(D) the total number of technology cer24 tification orders issued, and the total number of 

25 applications for technology certification that 


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1 were denied, including applications denied after 

2 the Secretary failed to make a determination 

3 within 30 calendar days of the transmittal date 

4 under subsection (b)(2)(B). 

5 ‘‘SEC. 587R. RECOGNIZED STANDARDS. 

6 ‘‘(a) IN GENERAL.—The Secretary may recognize all 

7 or part of appropriate standards established by nationally 

8 or internationally recognized standards development orga9 nizations for which a person may submit a declaration of 

10 conformity in order to meet a requirement under this sub11 chapter to which that standard is applicable. Standards 

12 for in vitro diagnostic devices previously recognized under 

13 section 514(c) shall be considered recognized standards 

14 under this section. Recognized and proposed standards 

15 shall be accessible to the public at no charge. The applica16 tion of any such consensus standard shall only apply pro17 spectively. The Secretary shall issue regulations estab18 lishing the criteria and process, for such recognition and 

19 adoption. 

20 ‘‘(b) AMENDMENT PROCESS.—The procedures estab21 lished in this section or in regulation or guidance issued 

22 under this section shall apply to amendment of an existing 

23 standard. 


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1 ‘‘SEC. 587S. INVESTIGATIONAL USE. 

2 ‘‘(a) IN GENERAL.—Subject to the conditions pre3 scribed in subsections (c), (d), (e), (f), and (g) of this sec4 tion, an in vitro clinical test for investigational use shall 

5 be exempt from the requirements of this subchapter other 

6 than sections 587A, 587P, 587T, and 587V. The Sec7 retary may amend parts 50, 54, and 56 of title 21 of the 

8 Code of Federal Regulations, or any successor regulations, 

9 to apply to in vitro clinical tests to permit the investiga10 tional use of such tests by experts qualified by scientific 

11 training and experience. 

12 ‘‘(b) REGULATIONS.— 

13 ‘‘(1) IN GENERAL.—Not later than 2 years 

14 after the date of enactment of the VALID Act of 

15 2022, the Secretary shall promulgate regulations, or 

16 amend existing regulations, to implement this sec17 tion. 

18 ‘‘(2) VARIATION.—The requirements in the reg19 ulations promulgated under this section shall take 

20 into account variations based on— 

21 ‘‘(A) the scope and duration of clinical 

22 testing to be conducted under investigation that 

23 is the subject of such application; 

24 ‘‘(B) the number of human subjects that 

25 are to be involved in such testing; 


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1 ‘‘(C) the need to permit changes to be 

2 made to the in vitro clinical test involved during 

3 testing conducted in accordance with a plan re4 quired under subsection (c)(5); or 

5 ‘‘(D) whether the clinical testing of such in 

6 vitro clinical test is for the purpose of devel7 oping data to obtain approval to offer such test. 

8 ‘‘(c) APPLICATION FOR INVESTIGATIONAL USE.— 

9 The following shall apply with respect to in vitro clinical 

10 tests for investigational use: 

11 ‘‘(1) SIGNIFICANT RISK AND OTHER STUD12 IES.—In the case of an in vitro clinical test the in13 vestigational use of which poses a significant risk to 

14 the human subject, a sponsor of an investigation of 

15 such a test seeking an investigational use exemption 

16 shall submit to the Secretary an investigational use 

17 application with respect to the in vitro clinical test 

18 in accordance with paragraphs (3) and (4). For pur19 poses of this subparagraph, the term ‘significant 

20 risk’ means, with respect to an in vitro clinical test 

21 and that the use of such in vitro clinical test— 

22 ‘‘(A) is of substantial importance in per23 forming an activity or activities described in 

24 section 201(ss)(1) for, a serious or life-threat25 ening disease or condition without confirmation 


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1 of the diagnosis by a medically established diag2 nostic product or procedure; 

3 ‘‘(B) requires an invasive sampling proce4 dure that presents a significant risk to the 

5 human subject, provided that routine 

6 venipuncture shall not be considered an invasive 

7 sampling procedure; or 

8 ‘‘(C) otherwise presents a potential for se9 rious risk to the health of a human subject. 

10 ‘‘(2) NON-SIGNIFICANT RISK STUDIES.—In the 

11 case of an in vitro clinical test, the investigational 

12 use of which is not described in paragraph (1)— 

13 ‘‘(A) the sponsor of such investigation 

14 shall— 

15 ‘‘(i) ensure such investigation is con16 ducted in compliance with an investiga17 tional plan approved by an institutional re18 view committee and the labeling of the in 

19 vitro clinical test involved clearly and con20 spicuously states, ‘For investigational use 

21 only’, as specified in paragraph (4)(A)(ii); 

22 ‘‘(ii) ensure each investigator obtains 

23 informed consent as required under part 

24 50, 54, and 56 of title 21, Code of Federal 

25 Regulations (or any successor regulations), 


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1 subject to the exceptions set forth in para2 graph (6)(C); 

3 ‘‘(iii) establish and maintain records 

4 with respect to all requirements in this 

5 subparagraph; 

6 ‘‘(iv) maintain records and make re7 ports as established by the Secretary in 

8 regulations issued under subsection (b); 

9 and 

10 ‘‘(v) ensure that investigators monitor 

11 investigations, maintain records and make 

12 reports as established by the Secretary in 

13 regulations issued under subsection (b); 

14 and 

15 ‘‘(B) the sponsor may rely on any excep16 tion or exemption described in paragraph 

17 (5)(B) or as established by the Secretary in 

18 regulations issued under subsection (b). 

19 ‘‘(3) APPLICATION.—An investigational use ap20 plication shall be submitted in such time and man21 ner and contain such information as the Secretary 

22 may require in regulation, and shall include an in23 vestigational plan for proposed clinical testing and 

24 assurances that the sponsor submitting the applica25 tion will— 


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1 ‘‘(A) establish and maintain records rel2 evant to the investigation of such in vitro clin3 ical test; and 

4 ‘‘(B) submit to the Secretary annual re5 ports of data obtained as a result of the inves6 tigational use of the in vitro clinical test during 

7 the period covered by the exemption that the 

8 Secretary reasonably determines will enable the 

9 Secretary— 

10 ‘‘(i) to ensure compliance with the 

11 conditions for the exemption specified in 

12 paragraph (4); 

13 ‘‘(ii) to review the progress of the in14 vestigation involved; and 

15 ‘‘(iii) to evaluate the ability to meet 

16 the applicable standard. 

17 ‘‘(4) CONDITIONS FOR EXEMPTION.— 

18 ‘‘(A) IN GENERAL.—An application for an 

19 investigational use exemption with respect to a 

20 significant risk study shall be granted if each of 

21 the following conditions is met: 

22 ‘‘(i) The risks to the subjects of the in 

23 vitro clinical test are outweighed by the an24 ticipated benefits of the test to the subjects 

25 and the importance of the knowledge to be 


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1 gained, and adequate assurance of in2 formed consent is provided in accordance 

3 with paragraphs (6)(A)(iii) and (6)(B). 

4 ‘‘(ii) The proposed labeling for the in 

5 vitro clinical test involved clearly and con6 spicuously states ‘For investigational use 

7 only’. 

8 ‘‘(iii) Such other requirements the 

9 Secretary determines— 

10 ‘‘(I) are necessary for the protec11 tion of the public health and safety; 

12 and 

13 ‘‘(II) do not unduly delay inves14 tigation. 

15 ‘‘(B) CERTAIN SIGNIFICANT RISK STUDIES

16 OF IN VITRO CLINICAL TESTS FOR AN UNMET

17 NEED.—The Secretary shall not impose a limit 

18 on the sample size for a significant risk study 

19 of an in vitro clinical test that has received 

20 breakthrough designation under section 587I. 

21 ‘‘(5) COORDINATION WITH INVESTIGATIONAL

22 NEW DRUG APPLICATIONS.—Any requirement for 

23 the submission of a report to the Secretary pursuant 

24 to an application for an investigational new drug ex25 emption involving an in vitro clinical test shall suVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00308 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 persede the reporting requirement in paragraph 

2 (3)(B), but only to the extent the requirement with 

3 respect to the application for exemption with respect 

4 to the drug is duplicative of the reporting require5 ment under such paragraph. 

6 ‘‘(6) INVESTIGATIONAL PLAN, PROCEDURES, 

7 AND CONDITIONS.—With respect to an investiga8 tional plan submitted under paragraph (3), the 

9 sponsor submitting such plan shall— 

10 ‘‘(A) promptly notify the Secretary of the 

11 approval or the suspension or termination of 

12 the approval of such plan by an institutional re13 view committee; 

14 ‘‘(B) in the case of an in vitro clinical test 

15 made available to investigators for clinical test16 ing, obtain agreements from each investigator 

17 that any testing of the in vitro clinical test in18 volving human subjects will be under such in19 vestigator’s supervision and in accordance with 

20 paragraph (C) and submit such agreements to 

21 the Secretary that ensure— 

22 ‘‘(i) all investigators will comply with 

23 this section, regulations promulgated or re24 vised under this section, and applicable 

25 human subjects regulations; and 


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1 ‘‘(ii) the investigator will ensure 

2 that— 

3 ‘‘(I) informed consent is obtained 

4 as required under part 50 of title 21, 

5 Code of Federal Regulations (or any 

6 successor regulations), amended to 

7 apply to in vitro clinical tests; and 

8 ‘‘(II) the requirements for insti9 tutional review board under part 56 of 

10 title 21 of the Code of Federal Regu11 lations (or successor regulations), 

12 amended to apply to in vitro clinical 

13 tests, are met; and 

14 ‘‘(C) assure that informed consent will be 

15 obtained from each human subject (or the rep16 resentative of such subject) of proposed clinical 

17 testing involving such in vitro clinical test, ex18 cept where, subject to such other conditions as 

19 the Secretary may prescribe— 

20 ‘‘(i) the proposed clinical testing poses 

21 no more than minimal risk to the human 

22 subject and includes appropriate safe23 guards to protect the rights, safety, and 

24 welfare of the human subject; or 


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1 ‘‘(ii) the investigator conducting or 

2 supervising the clinical testing determines 

3 in writing that there exists a life-threat4 ening situation involving the human sub5 ject of such testing which necessitates the 

6 use of such in vitro clinical test and it is 

7 not feasible to obtain informed consent 

8 from the subject and there is not sufficient 

9 time to obtain such consent from a rep10 resentative of such subject. 

11 ‘‘(7) CONCURRED BY LICENSED PHYSICIAN.— 

12 The determination required by paragraph (6)(C)(ii) 

13 shall be concurred in writing by a licensed physician 

14 who is not involved in the testing of the human sub15 ject with respect to which such determination is 

16 made unless immediate use of the device is required 

17 to save the life of the human subject of such testing 

18 and there is not sufficient time to obtain such con19 currence. 

20 ‘‘(d) REVIEW OF APPLICATIONS.— 

21 ‘‘(1) IN GENERAL.—The Secretary may issue 

22 an order approving an investigation as proposed, ap23 proving it with conditions or modifications, or dis24 approving it. 


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1 ‘‘(2) FAILURE TO ACT.—Unless the Secretary, 

2 not later than the date that is 30 calendar days 

3 after the date of the submission of an application for 

4 an investigational use exemption that meets the re5 quirements of subsection (c), issues an order under 

6 paragraph (1) and notifies the sponsor submitting 

7 the application, the application shall be treated as 

8 approved as of such date without further action by 

9 the Secretary. 

10 ‘‘(3) DENIAL.—The Secretary may deny an in11 vestigational use application submitted under this 

12 subsection if the Secretary determines that the in13 vestigation with respect to which the application is 

14 submitted does not conform to the requirements of 

15 subsection (c). A notification of such denial sub16 mitted to the sponsor with respect to such a request 

17 shall contain the order of disapproval and a complete 

18 statement of the reasons for the Secretary’s denial 

19 of the application. 

20 ‘‘(e) WITHDRAWAL OF EXEMPTION.— 

21 ‘‘(1) IN GENERAL.—The Secretary may, by ad22 ministrative order, withdraw an exemption approved 

23 under this section with respect to an in vitro clinical 

24 test, including an exemption treated as approved 

25 based on the Secretary’s failure to act pursuant to 


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1 subsection (d)(2), if the Secretary determines that 

2 an investigation conducted under such an exemption 

3 does not meet the applicable conditions under sub4 section (c)(3) for such exemption. 

5 ‘‘(2) OPPORTUNITY TO BE HEARD.— 

6 ‘‘(A) IN GENERAL.—Subject to subpara7 graph (B), an order withdrawing an investiga8 tional use exemption granted under this section 

9 may be issued only after the Secretary provides 

10 the sponsor of the in vitro clinical test with an 

11 opportunity for an informal hearing. 

12 ‘‘(B) EXCEPTION.—An order referred to in 

13 subparagraph (A) with respect to an investiga14 tional use exemption granted under this section 

15 may be issued on a preliminary basis before the 

16 provision of an opportunity for an informal 

17 hearing if the Secretary determines that the 

18 continuation of testing under the exemption will 

19 result in an unreasonable risk to the public 

20 health. The Secretary will provide an oppor21 tunity for an informal hearing promptly fol22 lowing any preliminary action under this sub23 paragraph. 

24 ‘‘(f) CHANGES.— 


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1 ‘‘(1) IN GENERAL.—The regulations promul2 gated under subsection (b) shall provide, with re3 spect to an in vitro clinical test for which an exemp4 tion under this subsection is in effect, procedures 

5 and conditions under which changes are allowed 

6 without the additional approval of an application for 

7 an exemption or submission of a supplement to such 

8 an application. Such regulations shall provide that 

9 such a change may be made if— 

10 ‘‘(A) the sponsor determines, on the basis 

11 of credible information (as defined in regula12 tions) that the change meets the conditions 

13 specified in paragraph (2); and 

14 ‘‘(B) the sponsor submits to the Secretary, 

15 not later than 5 calendar days after making the 

16 change, a notice of the change. 

17 ‘‘(2) CONDITIONS.—The conditions specified in 

18 this paragraph are that— 

19 ‘‘(A) in the case of developmental changes 

20 to an in vitro clinical test, including manufac21 turing changes, the changes— 

22 ‘‘(i) do not constitute a significant 

23 change in design or in basic principles of 

24 operation; 


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1 ‘‘(ii) do not affect the rights, safety, 

2 or welfare of the human subjects involved 

3 in the investigation; and 

4 ‘‘(iii) are made in response to infor5 mation gathered during the course of an 

6 investigation; and 

7 ‘‘(B) in the case of changes to clinical pro8 tocols applicable to the test, the changes do not 

9 affect— 

10 ‘‘(i) the validity of data or information 

11 resulting from the completion of an ap12 proved clinical protocol, or the relationship 

13 of likely patient risk to benefit relied upon 

14 to approve a product; 

15 ‘‘(ii) the scientific soundness of a plan 

16 submitted under subsection (c)(3); or 

17 ‘‘(iii) the rights, safety, or welfare of 

18 the human subjects involved in the inves19 tigation. 

20 ‘‘(g) CLINICAL HOLD.— 

21 ‘‘(1) IN GENERAL.—At any time, the Secretary 

22 may impose a clinical hold with respect to an inves23 tigation of an in vitro clinical test if the Secretary 

24 makes a written determination described in para25 graph (2). The Secretary shall, in imposing such 


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1 clinical hold, specify the basis for the clinical hold, 

2 including the specific information available to the 

3 Secretary which served as the basis for such clinical 

4 hold, and confirm such determination in writing. 

5 The applicant may immediately appeal any such de6 termination pursuant to section 587P. 

7 ‘‘(2) DETERMINATION.— 

8 ‘‘(A) IN GENERAL.—For purposes of para9 graph (1), a determination described in this 

10 subparagraph with respect to a clinical hold is 

11 a determination that, based on credible evi12 dence, the in vitro clinical test involved rep13 resents an unreasonable risk to the safety of 

14 the persons who are the subjects of the clinical 

15 investigation, taking into account the qualifica16 tions of the clinical investigators, information 

17 about the in vitro clinical test, the design of the 

18 clinical investigation, the condition for which 

19 the in vitro clinical test is to be investigated, 

20 and the health status of the subjects involved. 

21 ‘‘(B) REMOVAL OF CLINICAL HOLD.—Any 

22 written request to the Secretary from the spon23 sor of an investigation that a clinical hold be re24 moved shall receive a decision, in writing and 

25 specifying the reasons therefor, within 30 days 


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1 after receipt of such request. Any such request 

2 shall include sufficient information to support 

3 the removal of such clinical hold. 

4 ‘‘SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM. 

5 ‘‘(a) ESTABLISHMENT.—Not later than 2 years after 

6 the date of enactment of the VALID Act of 2022, the Sec7 retary shall make available a comprehensive test informa8 tion system for in vitro clinical tests that is designed to— 

9 ‘‘(1) provide a transparent interface on the 

10 website of the Food and Drug Administration for 

11 stakeholders, to the extent permitted by applicable 

12 law, which may include access to the— 

13 ‘‘(A) regulatory pathway designation infor14 mation for each in vitro clinical test or tests 

15 with the same indications for use; 

16 ‘‘(B) registration and listing information 

17 provided by developers under section 587J, in18 cluding the use of a link for labels; 

19 ‘‘(C) adverse event reports submitted 

20 under section 587M, as appropriate; 

21 ‘‘(D) reports of corrections and removals 

22 submitted under section 587N; and 

23 ‘‘(E) other information pertaining to an in 

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1 tions for use, as the Secretary determines ap2 propriate; and 

3 ‘‘(2) provide a secure portal for electronic sub4 mission, including applications and other in vitro 

5 clinical test submissions, registration and listing in6 formation, and adverse event reports, which provides 

7 protections from unauthorized disclosure of informa8 tion, including of— 

9 ‘‘(A) trade secret or commercial confiden10 tial information; and 

11 ‘‘(B) national security, countermeasure, or 

12 other information restricted from disclosure 

13 pursuant to any provision of law. 

14 ‘‘(b) SUBMISSION FUNCTION.—The comprehensive 

15 test information system shall serve as the electronic sub16 mission service for test developers submitting information 

17 for applications under sections 587B and 587D. 

18 ‘‘SEC. 587U. PREEMPTION. 

19 ‘‘(a) IN GENERAL.—Except as provided in subsection 

20 (b), no State, Tribal, or local government (or political sub21 division thereof) may establish or continue in effect any 

22 requirement that— 

23 ‘‘(1) is different from, or in addition to, any re24 quirement applicable to an in vitro clinical test 

25 under this Act; or 


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1 ‘‘(2) with respect to the analytical validity, clin2 ical validity, or safety for individuals who come into 

3 contact with such an in vitro clinical test under this 

4 Act. 

5 ‘‘(b) EXCEPTIONS.—Subsection (a) shall not be con6 strued to affect the authority of a State, Tribal, or local 

7 government to do any of the following: 

8 ‘‘(1) To license laboratory personnel, health 

9 care practitioners, or health care facilities or to reg10 ulate any aspect of a health care practitioner-patient 

11 relationship. 

12 ‘‘(2) To enforce laws of general applicability, 

13 such as zoning laws, environmental laws, labor laws, 

14 and general business laws. 

15 ‘‘(3) To authorize laboratories to develop and 

16 perform an in vitro clinical test, pursuant to a law 

17 enacted by a State prior to January 1, 2022, as long 

18 as such law does not impose requirements that are 

19 different from any requirement applicable to an in 

20 vitro clinical test under this Act. If a State has en21 acted such a law, the Secretary may exempt such 

22 laboratories in that State from compliance with this 

23 subchapter. 

24 ‘‘(c) CLARIFICATION.—Nothing in this section shall 

25 be construed to— 


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1 ‘‘(1) modify any action for damages or the li2 ability of any person under the law of any State; or 

3 ‘‘(2) shift liability to health care practitioners 

4 or other users. 

5 ‘‘SEC. 587V. ADULTERATION. 

6 ‘‘An in vitro clinical test shall be deemed to be adul7 terated: 

8 ‘‘(1) If it consists in whole or in part of any 

9 filthy, putrid, or decomposed substance. 

10 ‘‘(2) If it has been developed, prepared, packed, 

11 or held under insanitary conditions whereby it may 

12 have been contaminated with filth, or whereby it 

13 may have been rendered injurious to health. 

14 ‘‘(3) If its container or package is composed, in 

15 whole or in part, of any poisonous or deleterious 

16 substance which may render the contents injurious 

17 to health. 

18 ‘‘(4) If it bears or contains, for purposes of 

19 coloring only, a color additive which is unsafe within 

20 the meaning of section 721(a). 

21 ‘‘(5) If its analytical or clinical validity, as ap22 plicable, or with respect to a specimen receptacle, its 

23 safety, falls below that which it purports or is rep24 resented to possess. 


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1 ‘‘(6) If it is required to be, declared to be, pur2 ports to be, or is represented as being, in conformity 

3 with any performance standard established or recog4 nized under section 587R and is not in conformity 

5 with such standard. 

6 ‘‘(7) If it is required to be in compliance with 

7 mitigating measures established under section 587E 

8 and is not in conformity with such mitigating meas9 ures. 

10 ‘‘(8) If it fails to have in effect an approved 

11 premarket application under section 587B unless 

12 such in vitro clinical test is in compliance with the 

13 requirements for— 

14 ‘‘(A) offering without an approved pre15 market application under section 587D; 

16 ‘‘(B) an exemption from premarket ap17 proval under section 587C or 587G; or 

18 ‘‘(C) investigational use pursuant to sec19 tion 587S. 

20 ‘‘(9) If it is not in conformity with any condi21 tion established under section 587B or 587D. 

22 ‘‘(10) If it purports to be an in vitro clinical 

23 test subject to an exemption under section 587C and 

24 it fails to meet or maintain any criteria, condition, 

25 or requirement of such exemption. 


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1 ‘‘(11) If it has been granted an exemption 

2 under section 587S for investigational use, and the 

3 person granted such exemption or any investigator 

4 who uses such in vitro clinical test under such ex5 emption fails to comply with a requirement pre6 scribed by or under such section. 

7 ‘‘(12) If it fails to meet the quality require8 ments prescribed in or established under section 

9 587K (as applicable), or the methods used in, or fa10 cilities or controls used for, its development, pack11 aging, storage, or installation are not in conformity 

12 with applicable requirements established under such 

13 section. 

14 ‘‘(13) If it has been developed, processed, pack15 aged, or held in any establishment, factory, or ware16 house and the owner, operator or agent of such es17 tablishment, factory, or warehouse delays, denies, or 

18 limits an inspection, or refuses to permit entry or in19 spection. 

20 ‘‘(14) If it is not in compliance with any restric21 tion required under section 587O. 

22 ‘‘SEC. 587W. MISBRANDING. 

23 ‘‘An in vitro clinical test shall be deemed to be mis24 branded: 


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1 ‘‘(1) If its labeling is false or misleading in any 

2 particular. 

3 ‘‘(2) If in a package form unless it bears a label 

4 containing— 

5 ‘‘(A) the name and place of business of the 

6 test developer, packager, or distributor; and 

7 ‘‘(B) an accurate statement of the quantity 

8 of contents in terms of weight, measure, or nu9 merical count with respect to small packages, 

10 unless an exemption is granted by the Secretary 

11 by the issuance of guidance. 

12 ‘‘(3) If any word, statement, or other informa13 tion required by or under authority of this Act to 

14 appear on the label or labeling, including a test re15 port, is not prominently placed thereon with such 

16 conspicuousness (as compared with other words, 

17 statements, designs, or devices, in the labeling) and 

18 in such terms as to render it likely to be read and 

19 understood by the ordinary individual under cus20 tomary conditions of purchase and use. 

21 ‘‘(4) Unless its labeling bears adequate direc22 tions for use and such adequate warnings as are 

23 necessary for the protection of users of the in vitro 

24 clinical test and recipients of the results of such in 

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1 nors, and related health care professionals. Required 

2 labeling for in vitro clinical tests intended for use in 

3 health care facilities, blood establishments, or by a 

4 health care professional may be made available solely 

5 by electronic means, provided that the labeling com6 plies with all applicable requirements of law, and 

7 that the test developer, or distributor affords such 

8 users the opportunity to request the labeling in 

9 paper form, and after such request, promptly pro10 vides the requested information without additional 

11 cost. 

12 ‘‘(5) If there is a reasonable probability that it 

13 could cause serious or adverse health consequences 

14 or death, including through absence, delay, or dis15 continuation in diagnosis or treatment, when used in 

16 the manner prescribed, recommended, or suggested 

17 in the labeling thereof. 

18 ‘‘(6) If it was developed, sterilized, packaged, 

19 repackaged, relabeled, installed, or imported in an 

20 establishment not duly registered under section 

21 587J or it was not included in a listing under sec22 tion 587J, in accordance with timely reporting re23 quirements under this subchapter. 

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1 vertising is false or misleading in any particular, (2) 

2 if it is offered for clinical use, sold, distributed, or 

3 used in violation of such restrictions, or (3) unless 

4 the test developer or distributor includes in all ad5 vertisements and other descriptive printed matter 

6 that such person issues or causes to be issued, a 

7 brief statement of the indications for use of the in 

8 vitro clinical test and relevant warnings, precautions, 

9 side effects, and contraindications. This subsection 

10 shall not be applicable to any printed matter that 

11 the Secretary determines to be labeling as defined in 

12 section 201(m). 

13 ‘‘(8) If it is subject to a mitigating measure es14 tablished under section 587E and does not bear such 

15 labeling as may be prescribed in such mitigating 

16 measure. 

17 ‘‘(9) If it is subject to a standard established 

18 under section 587R and it does not bear such label19 ing as may be prescribed in such standard. 

20 ‘‘(10) Unless it bears such labeling as may be 

21 required by or established under an applicable label22 ing requirement under this Act. 

23 ‘‘(11) If there was a failure to comply with any 

24 requirement prescribed in or under section 587D, 

25 587J, 587K, 587L, 587M, 587N, 587X, 587Y, 


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1 587Z, or to provide any report, material, or other in2 formation required with respect to in vitro clinical 

3 tests under this subchapter. 

4 ‘‘SEC. 587X. POSTMARKET SURVEILLANCE. 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) IN GENERAL.—In addition to other appli7 cable requirements under this Act, the Secretary 

8 may issue an order requiring a developer of a high9 risk or moderate-risk in vitro clinical test to conduct 

10 postmarket surveillance of such in vitro clinical test, 

11 if the failure of the in vitro clinical test is reasonably 

12 likely to result in serious adverse health con13 sequences or death from use of such in vitro clinical 

14 test. 

15 ‘‘(2) CONSIDERATION.—In determining whether 

16 to require a developer to conduct postmarket surveil17 lance of an in vitro clinical test, the Secretary shall 

18 take into consideration the benefits and risks for the 

19 patient and the least burdensome principles under 

20 section 587B(j). 

21 ‘‘(b) SURVEILLANCE APPROVAL.— 

22 ‘‘(1) IN GENERAL.—Each developer required to 

23 conduct surveillance of an in vitro clinical test shall 

24 submit, within 30 days of receiving an order from 

25 the Secretary, a plan for the required surveillance. 


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1 The Secretary, within 60 days of the receipt of such 

2 plan, shall determine if the person designated to 

3 conduct the surveillance has the appropriate quali4 fications and experience to undertake such surveil5 lance and if the plan will result in useful data that 

6 can reveal unforeseen adverse events or other infor7 mation necessary to protect the health of patients or 

8 the public. 

9 ‘‘(2) TIMELINE.—The developer shall com10 mence surveillance under this section not later than 

11 15 months after the day on which the Secretary or12 ders such postmarket surveillance, unless the Sec13 retary determines more time is needed to commence 

14 surveillance. 

15 ‘‘(3) PROSPECTIVE SURVEILLANCE.—The Sec16 retary may order a prospective surveillance period of 

17 up to 3 years. Any determination by the Secretary 

18 that a longer period is necessary shall be made by 

19 mutual agreement between the Secretary and the de20 veloper or, if no agreement can be reached, upon the 

21 completion of a dispute resolution process pursuant 

22 to section 562. 


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1 ‘‘SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS. 

2 ‘‘(a) IN GENERAL.—All submissions to the Food and 

3 Drug Administration with respect to an in vitro clinical 

4 test, unless otherwise agreed to by the Secretary, shall— 

5 ‘‘(1) be made electronically; and 

6 ‘‘(2) with respect to the information required 

7 under sections 587B and 587D, utilize the system 

8 described in section 587U. 

9 ‘‘(b) ELECTRONIC FORMAT.—Beginning on such date 

10 as the Secretary specifies in final guidance issued under 

11 subsection (c), submissions for in vitro clinical tests, in12 cluding recommendations submitted by accredited and rec13 ognized persons under section 587Q, and any appeals of 

14 action taken by the Secretary with respect to such submis15 sions, shall be submitted in such electronic format as spec16 ified by the Secretary in such guidance. 

17 ‘‘(c) GUIDANCE.—The Secretary shall issue guidance 

18 implementing this section. Such guidance may— 

19 ‘‘(1) provide standards for the electronic sub20 mission required under subsection (a) or the submis21 sion in electronic format required under subsection 

22 (b); 

23 ‘‘(2) set forth criteria for waivers of, or exemp24 tions from, the requirements of subsection (a) or (b); 

25 and 


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1 ‘‘(3) provide any other information for the effi2 cient implementation and enforcement of this sec3 tion. 

4 ‘‘SEC. 587Z. POSTMARKET REMEDIES. 

5 ‘‘(a) SAFETY NOTICE.— 

6 ‘‘(1) IN GENERAL.—If the Secretary determines 

7 that an in vitro clinical test presents an unreason8 able risk of substantial harm to the public health, 

9 and notification under this subsection is necessary to 

10 eliminate the unreasonable risk of such harm and no 

11 more practicable means is available under the provi12 sions of this Act (other than this section) to elimi13 nate the risk, the Secretary may issue such order as 

14 may be necessary to ensure that adequate safety no15 tice is provided in an appropriate form, by the per16 sons and means best suited under the circumstances, 

17 to all health care professionals who prescribe, order, 

18 or use the in vitro clinical test and to any other per19 son (including developers, importers, distributors, re20 tailers, and users) who should properly receive such 

21 notice. 

22 ‘‘(2) NOTICE TO INDIVIDUALS.—An order 

23 under this subsection shall require that the individ24 uals subject to the risk with respect to which the 

25 order is to be issued be included in the persons to 


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1 be notified of the risk unless the Secretary deter2 mines that notice to such individuals would present 

3 a greater danger to the health of such individuals 

4 than no such notice. If the Secretary makes such a 

5 determination with respect to such individuals, the 

6 order shall require the health care professionals who 

7 prescribed, ordered, or used the in vitro clinical test 

8 provide notification to the individuals for whom the 

9 health professionals prescribed, ordered, or used 

10 such test, of the risk presented by such in vitro clin11 ical test and of any action which may be taken by 

12 or on behalf of such individuals to eliminate or re13 duce such risk. Before issuing an order under this 

14 subsection, the Secretary shall consult with the per15 sons required to give notice under the order. 

16 ‘‘(b) REPAIR, REPLACEMENT, OR REFUND.— 

17 ‘‘(1) DETERMINATION AFTER AN INFORMAL

18 HEARING.— 

19 ‘‘(A) IN GENERAL.—If, after affording op20 portunity for an informal hearing, the Secretary 

21 determines that— 

22 ‘‘(i) an in vitro clinical test presents 

23 an unreasonable risk of substantial harm 

24 to the public health; 


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1 ‘‘(ii) there are reasonable grounds to 

2 believe that the in vitro clinical test was 

3 not properly developed or manufactured 

4 considering the state of the art as it ex5 isted at the time of its development; 

6 ‘‘(iii) there are reasonable grounds to 

7 believe that the unreasonable risk was not 

8 caused by failure of a person other than a 

9 developer, importer, distributor, or retailer 

10 of the in vitro clinical test to exercise due 

11 care in the installation, maintenance, re12 pair, or use of the in vitro clinical test; and 

13 ‘‘(iv) the notice authorized by sub14 section (a) would not by itself be sufficient 

15 to eliminate the unreasonable risk and ac16 tion described in paragraph (2) of this sub17 section is necessary to eliminate such risk, 

18 the Secretary may order the developer, im19 porter, or any distributor of such in vitro clin20 ical test, or any combination of such persons, to 

21 submit to him within a reasonable time a plan 

22 for taking one or more of the actions described 

23 in paragraph (2). An order issued under the 

24 preceding sentence which is directed to more 

25 than one person shall specify which person may 


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1 decide which action shall be taken under such 

2 plan and the person specified shall be the per3 son who the Secretary determines bears the 

4 principal, ultimate financial responsibility for 

5 action taken under the plan unless the Sec6 retary cannot determine who bears such respon7 sibility or the Secretary determines that the 

8 protection of the public health requires that 

9 such decision be made by a person (including a 

10 health professional or user of the in vitro clin11 ical test) other than the person the Secretary 

12 determines bears such responsibility. 

13 ‘‘(B) SECRETARY APPROVAL OF PLAN.— 

14 The Secretary shall approve a plan submitted 

15 pursuant to an order issued under subpara16 graph (A) unless the Secretary determines 

17 (after affording opportunity for an informal 

18 hearing) that the action or actions to be taken 

19 under the plan or the manner in which such ac20 tion or actions are to be taken under the plan 

21 will not assure that the unreasonable risk with 

22 respect to which such order was issued will be 

23 eliminated. If the Secretary disapproves a plan, 

24 the Secretary shall order a revised plan to be 

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1 retary determines (after affording opportunity 

2 for an informal hearing) that the revised plan 

3 is unsatisfactory or if no revised plan or no ini4 tial plan has been submitted to the Secretary 

5 within the prescribed time, the Secretary shall 

6 (i) prescribe a plan to be carried out by the per7 son or persons to whom the order issued under 

8 subparagraph (A) was directed, or (ii) after af9 fording an opportunity for an informal hearing, 

10 by order prescribe a plan to be carried out by 

11 a person who is a developer, importer, dis12 tributor, or retailer of the in vitro clinical test 

13 with respect to which the order was issued but 

14 to whom the order under subparagraph (A) was 

15 not directed. 

16 ‘‘(2) ACTIONS ON A PLAN.—The actions which 

17 may be taken under a plan submitted under an 

18 order issued under paragraph (1)(A) are as follows: 

19 ‘‘(A) To repair the in vitro clinical test so 

20 that it does not present the unreasonable risk 

21 of substantial harm with respect to which the 

22 order under paragraph (1)(A) was issued. 

23 ‘‘(B) To replace the in vitro clinical test 

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1 formity with all applicable requirements of this 

2 Act. 

3 ‘‘(C) To refund the purchase price of the 

4 in vitro clinical test (less a reasonable allowance 

5 for use if such in vitro clinical test has been in 

6 the possession of the user for one year or more 

7 at the time of notice ordered under subsection 

8 (a), or at the time the user receives actual no9 tice of the unreasonable risk with respect to 

10 which the order was issued under paragraph 

11 (1)(A), whichever occurs first). 

12 ‘‘(3) NO CHARGE.—No charge shall be made to 

13 any person (other than a developer, importer, dis14 tributor or retailer) for using a remedy described in 

15 paragraph (2) and provided under an order issued 

16 under paragraph (1), and the person subject to the 

17 order shall reimburse each person (other than a de18 veloper, manufacturer, importer, distributor, or re19 tailer) who is entitled to such a remedy for any rea20 sonable and foreseeable expenses actually incurred 

21 by such person in using such remedy. 

22 ‘‘(c) REIMBURSEMENT.—An order issued under sub23 section (b)(1)(A) with respect to an in vitro clinical test 

24 may require any person who is a developer, importer, dis25 tributor, or retailer of the in vitro clinical test to reimburse 


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1 any other person who is a developer, importer, distributor, 

2 or retailer of such in vitro clinical test for such other per3 son’s expenses actually incurred in connection with car4 rying out the order if the Secretary determines such reim5 bursement is required for the protection of the public 

6 health. Any such requirement shall not affect any rights 

7 or obligations under any contract to which the person re8 ceiving reimbursement or the person making such reim9 bursement is a party. 

10 ‘‘(d) RECALL AUTHORITY.— 

11 ‘‘(1) IN GENERAL.—If the Secretary finds that 

12 there is a reasonable probability that an in vitro 

13 clinical test approved under section 587B or offered 

14 under a technology certification order under section 

15 587D would cause serious, adverse health con16 sequences or death, including by the absence, signifi17 cant delay, or discontinuation of appropriate medical 

18 treatment, the Secretary shall issue an order requir19 ing the appropriate person (including the developers, 

20 importers, distributors, or retailers of the in vitro 

21 clinical test)— 

22 ‘‘(A) to immediately cease distribution of 

23 such in vitro clinical test; and 

24 ‘‘(B) to immediately notify health profes25 sionals and applicable in vitro clinical test user 


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1 facilities of the order and to instruct such pro2 fessionals and facilities to cease use of such in 

3 vitro clinical test. 

4 ‘‘(2) INFORMAL HEARING.—The order issued 

5 under paragraph (1)(A), shall provide the person 

6 subject to the order with an opportunity for an in7 formal hearing, to be held not later than 10 calendar 

8 days after the date of the issuance of the order, on 

9 the actions required by the order and on whether the 

10 order should be amended to require a recall of such 

11 in vitro clinical test. If, after providing an oppor12 tunity for such a hearing, the Secretary determines 

13 that inadequate grounds exist to support the actions 

14 required by the order, the Secretary shall vacate the 

15 order. 

16 ‘‘(3) AMENDED ORDER.— 

17 ‘‘(A) IN GENERAL.—If, after providing an 

18 opportunity for an informal hearing under 

19 paragraph (2), the Secretary determines that 

20 the order should be amended to include a recall 

21 of the in vitro clinical test with respect to which 

22 the order was issued, the Secretary shall, except 

23 as provided in subparagraph (B), amend the 

24 order to require a recall. The Secretary shall 

25 specify a timetable in which the recall will occur 


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1 and shall require periodic reports describing the 

2 progress of the recall. 

3 ‘‘(B) REQUIREMENTS.—An amended order 

4 under subparagraph (A)— 

5 ‘‘(i) shall not include recall of the in 

6 vitro clinical test from individuals; 

7 ‘‘(ii) shall not include recall of an in 

8 vitro clinical test from test user facilities if 

9 the Secretary determines that the risk of 

10 recalling such in vitro clinical test from the 

11 facilities presents a greater health risk 

12 than the health risk of not recalling the in 

13 vitro clinical test from use; and 

14 ‘‘(iii) shall provide for notice to indi15 viduals subject to the risks associated with 

16 the use of such in vitro clinical test. In 

17 providing the notice required by this 

18 clause, the Secretary may use the assist19 ance of health professionals who pre20 scribed, ordered, or used such an in vitro 

21 clinical test for individuals. 

22 ‘‘(4) CLARIFICATION.—The remedy provided by 

23 this subsection shall be in addition to remedies pro24 vided by subsections (a), (b), and (c). 


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1 ‘‘SEC. 587AA. APPLICABILITY. 

2 ‘‘(a) IN GENERAL.—An in vitro clinical test shall be 

3 subject to the requirements of this subchapter, except as 

4 otherwise provided in this subchapter. 

5 ‘‘(b) INTERSTATE COMMERCE.—Any in vitro clinical 

6 test that is offered, including by making available for clin7 ical use in the United States is deemed to be an act that 

8 constitutes introduction into interstate commerce for pur9 poses of enforcing the requirements of this Act. 

10 ‘‘(c) LEAST BURDENSOME REQUIREMENTS.— 

11 ‘‘(1) IN GENERAL.—In carrying out this sub12 chapter, the Secretary shall consider the least bur13 densome means necessary to meet the applicable 

14 standard, and other regulatory requirements, as de15 termined by the Secretary. 

16 ‘‘(2) NECESSARY DEFINED.—For purposes of 

17 paragraph (1) and paragraph (3), the term ‘nec18 essary’ means the minimum required information 

19 that would support a determination by the Secretary 

20 that the application meet the applicable standard or 

21 regulatory requirement, as determined by the Sec22 retary. 

23 ‘‘(d) SERVICE OF ORDERS.—Orders of the Secretary 

24 under this section with respect to applications under sub25 section (a) or (b) of section 587B or supplements under 

26 subsection (f) of such section shall be served— 


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1 ‘‘(1) in person by any officer or employee of the 

2 Department of Health and Human Services des3 ignated by the Secretary; or 

4 ‘‘(2) by mailing the order by registered mail or 

5 certified mail or electronic equivalent addressed to 

6 the applicant at the last known address in the 

7 records of the Secretary. 

8 ‘‘(e) LABORATORIES AND BLOOD AND TISSUE ES9 TABLISHMENTS.— 

10 ‘‘(1) RELATION TO LABORATORY CERTIFI11 CATION PURSUANT TO SECTION 353 OF THE PUBLIC

12 HEALTH SERVICE ACT.—Nothing in this subchapter 

13 shall be construed to modify the authority of the 

14 Secretary with respect to laboratories or clinical lab15 oratories under section 353 of the Public Health 

16 Service Act. 

17 ‘‘(2) AVOIDING DUPLICATION.—In imple18 menting this subchapter, the Secretary shall avoid 

19 issuing or enforcing regulations or guidance that are 

20 duplicative of regulations or guidance under section 

21 353 of the Public Health Service Act. 

22 ‘‘(3) BLOOD AND TISSUE.—Nothing in this sub23 chapter shall be construed to modify the authority of 

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1 gaged in the propagation, manufacture, or prepara2 tion, including filling, labeling, packaging, and stor3 age, of blood, blood components, human cells, tis4 sues, or tissue products pursuant to any require5 ments under this Act or section 351 or 361 of the 

6 Public Health Service Act. 

7 ‘‘(f) NOT COMBINATION PRODUCT.—A product con8 stituted of a device and an in vitro clinical test is not a 

9 combination product and shall be regulated as a device. 

10 ‘‘(g) PRACTICE OF MEDICINE.—Nothing in this sub11 chapter shall be construed to limit or interfere with the 

12 authority of a health care practitioner to prescribe or ad13 minister any lawfully offered in vitro clinical test for any 

14 condition or disease within a legitimate health care practi15 tioner-patient relationship pursuant to applicable Federal 

16 or State law. 

17 ‘‘(h) RULES OF CONSTRUCTION.— 

18 ‘‘(1) SALE, DISTRIBUTION, LABELING.—Noth19 ing in this paragraph shall be construed to limit the 

20 authority of the Secretary to establish or enforce re21 strictions on the sale, distribution, or labeling of an 

22 in vitro clinical test under this Act. 

23 ‘‘(2) PROMOTION OF UNAPPROVED USES.— 

24 Nothing in this paragraph shall be construed to alter 


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1 any prohibition on the promotion of unapproved uses 

2 of legally marketed in vitro clinical tests. 

3 ‘‘SEC. 587BB. JUDICIAL REVIEW. 

4 ‘‘(a) IN GENERAL.—Not later than 30 days after an 

5 order issued pursuant to sections 587B or 587D, any per6 son adversely affected by such order may file a petition 

7 with the United States Court of Appeals for the District 

8 of Columbia or for the circuit wherein such person resides 

9 or has a principal place of business for judicial review of 

10 such order, in accordance with the procedure set forth in 

11 section 517(a). 

12 ‘‘(b) APPLICATION OF PROVISIONS.—Subsections (a) 

13 through (e) of section 517 shall apply with respect to a 

14 petition under subsection (a) of this section in the same 

15 manner such subsections apply to a petition under section 

16 517. Subsection (f) of section 517 shall apply to an order 

17 issued under section 587B or 587D.’’. 

18 SEC. 824. ENFORCEMENT AND OTHER PROVISIONS. 

19 (a) PROHIBITED ACTS.—Section 301 of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 

21 amended by section 811, is further amended— 

22 (1) in paragraphs (a), (b), (c), (g), (h), (k), (q), 

23 (r), and (y), by inserting ‘‘in vitro clinical test,’’ 

24 after ‘‘device,’’ each place it appears; 


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1 (2) in paragraph (g), by inserting after ‘‘mis2 branded’’, ‘‘, and the development within any Terri3 tory of any in vitro clinical test that is adulterated 

4 or misbranded’’; 

5 (3) in paragraph (y), by inserting ‘‘or 587Q’’ 

6 after ‘‘section 523’’ each place it appears; 

7 (4) in paragraph (ff), by striking ‘‘or device’’ 

8 and inserting ‘‘, device, or in vitro clinical test’’; and 

9 (5) by adding at the end, the following: 

10 ‘‘(jjj)(1) Forging, counterfeiting, simulating, or false11 ly representing, or without proper authority using any 

12 mark, stamp, tag, label, or other identification upon any 

13 in vitro clinical test or container, packaging, or labeling 

14 thereof so as to render such in vitro clinical test a counter15 feit in vitro clinical test. 

16 ‘‘(2) Making, selling, disposing of, or keeping in pos17 session, control, or custody, or concealing any punch, die, 

18 plate, stone, or other thing designed to print, imprint, or 

19 reproduce the trademark, trade name, or other identifying 

20 mark or imprint of another or any likeness of any of the 

21 foregoing upon any in vitro clinical test or container, pack22 aging, or labeling thereof so as to render such in vitro 

23 clinical test a counterfeit in vitro clinical test. 

24 ‘‘(3) The doing of any act which causes an in vitro 

25 clinical test to be a counterfeit in vitro clinical test, or 


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1 the sale or dispensing, or the holding for sale or dis2 pensing, of a counterfeit in vitro clinical test. 

3 ‘‘(kkk)(1) The introduction or delivery for introduc4 tion into interstate commerce of an in vitro clinical test 

5 in violation of section 587B(a). 

6 ‘‘(2) The making of a false, fraudulent, or deceptive 

7 statement about an in vitro clinical test that is exempt 

8 from premarket review under section 587C. 

9 ‘‘(3) The failure to maintain complete and accurate 

10 documentation for an exemption as required under section 

11 587C or the failure to provide labeling required under sec12 tion 587L. 

13 ‘‘(4) With respect to an in vitro clinical test, the sub14 mission of any report or listing under this Act that is false 

15 or misleading in any material respect. 

16 ‘‘(5) The failure to comply with a condition of ap17 proval, or restriction required under an approved applica18 tion under section 587B; the failure to perform a risk 

19 analysis required by section 587B; the failure to submit 

20 an annual update required under section 587J(c)(2)(B); 

21 or the failure to complete postmarket surveillance as re22 quired under section 587X. 

23 ‘‘(6) The failure to comply with applicable require24 ments to submit an application or report under section 

25 587D(e). 


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1 ‘‘(7) The failure to comply with applicable mitigating 

2 measures established under section 587E or to submit, 

3 maintain, or make available the documentation required 

4 under section 587E(b); or the failure to comply with appli5 cable performance standards established under section 

6 587R. 

7 ‘‘(8) The failure to register in accordance with section 

8 587J, the failure to provide information required under 

9 section 587J(b), or the failure to maintain or submit infor10 mation required under section 587J(c). 

11 ‘‘(9) The failure to comply with requirements under 

12 section 587M or 587N, the failure to comply with a re13 striction required under section 587O, or the failure to 

14 comply with labeling and advertising requirements under 

15 section 587O(b). 

16 ‘‘(10) The failure to comply with the requirements 

17 of section 587Q. 

18 ‘‘(11) The failure to comply with any requirement of 

19 section 587S; the failure to furnish any notification, infor20 mation, material, or report required under section 587S; 

21 or the failure to comply with an order issued under section 

22 587S. 

23 ‘‘(12) The failure to furnish information requested by 

24 the Secretary under 587G(d)(2).’’. 


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1 (b) PENALTIES.—Section 303 of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 333) is amended— 

3 (1) in subsection (b)(8), by inserting ‘‘or coun4 terfeit in vitro clinical test’’ after ‘‘counterfeit drug’’; 

5 (2) in subsection (c)— 

6 (A) by striking ‘‘; or (5)’’ and inserting ‘‘; 

7 (5)’’; and 

8 (B) by inserting before the period at the 

9 end the following: ‘‘; or (6) for having violated 

10 section 301(fff)(2) if such person acted in good 

11 faith and had no reason to believe that use of 

12 the punch, die, plate, stone, or other thing in13 volved would result in an in vitro clinical test 

14 being a counterfeit in vitro clinical test, or for 

15 having violated section 301(fff)(3) if the person 

16 doing the act or causing it to be done acted in 

17 good faith and had no reason to believe that the 

18 in vitro clinical test was a counterfeit in vitro 

19 clinical test’’; and 

20 (3) in subsection (f)(1)— 

21 (A) in subparagraph (A)— 

22 (i) by inserting ‘‘or in vitro clinical 

23 tests’’ after ‘‘which relates to devices’’; 

24 (ii) by inserting ‘‘or section 

25 587Q(a)(2)’’ after ‘‘section 704(g)’’; and 


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1 (iii) by inserting ‘‘or in vitro clinical 

2 tests, as applicable’’ before the period at 

3 the end of the second sentence; and 

4 (B) in subparagraph (B)(i), by striking ‘‘or 

5 520(f)’’ and inserting ‘‘, 520(f), 587K, or 

6 587M,’’. 

7 (c) SEIZURE.—Section 304 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 334) is amended— 

9 (1) in subsection (a)(2)— 

10 (A) by striking ‘‘, and (E)’’ and inserting 

11 ‘‘, (E)’’; and 

12 (B) by inserting before the period at the 

13 end the following: ‘‘, and (F) Any in vitro clin14 ical test that is a counterfeit in vitro clinical 

15 test, (G) Any container, packaging, or labeling 

16 of a counterfeit in vitro clinical test, and (H) 

17 Any punch, die, plate, stone, labeling, container, 

18 or other thing used or designed for use in mak19 ing a counterfeit in vitro clinical test’’; 

20 (2) in subsection (d)(1), by inserting ‘‘in vitro 

21 clinical test,’’ after ‘‘device,’’; and 

22 (3) in subsection (g)— 

23 (A) in paragraph (1), by inserting ‘‘, in 

24 vitro clinical test,’’ after ‘‘device’’ each place it 

25 appears; and 


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1 (B) in paragraph (2)— 

2 (i) in subparagraph (A), by inserting 

3 ‘‘, in vitro clinical test,’’ after ‘‘device’’; 

4 and 

5 (ii) in subparagraph (B), by inserting 

6 ‘‘or in vitro clinical test’’ after ‘‘device’’ 

7 each place it appears. 

8 (d) DEBARMENT, TEMPORARY DENIAL OF AP9 PROVAL, AND SUSPENSION.—Section 306 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is 

11 amended by adding at the end the following: 

12 ‘‘(n) IN VITRO CLINICAL TESTS; MANDATORY DE13 BARMENT REGARDING THIRD-PARTY INSPECTIONS AND

14 REVIEWS.— 

15 ‘‘(1) IN GENERAL.—If the Secretary finds that 

16 a person has been convicted of a felony for a viola17 tion of section 301(gg) or 301(jjj)(1), the Secretary 

18 shall debar such person from being accredited under 

19 section 587Q and from carrying out activities under 

20 an agreement described in section 803(b). 

21 ‘‘(2) DEBARMENT PERIOD.—The Secretary 

22 shall debar a person under paragraph (1) for the fol23 lowing periods: 

24 ‘‘(A) The period of debarment of a person 

25 (other than an individual) shall not be less than 


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1 1 year or more than 10 years, but if an act 

2 leading to a subsequent debarment under such 

3 paragraph occurs within 10 years after such 

4 person has been debarred under such para5 graph, the period of debarment shall be perma6 nent. 

7 ‘‘(B) The debarment of an individual shall 

8 be permanent. 

9 ‘‘(3) TERMINATION OF DEBARMENT; JUDICIAL

10 REVIEW; OTHER MATTERS.—Subsections (c)(3), (d), 

11 (e), (i), (j), and (l)(1) apply with respect to a person 

12 (other than an individual) or an individual who is 

13 debarred under paragraph (1) to the same extent 

14 and in the same manner as such subsections apply 

15 with respect to a person who is debarred under sub16 section (a)(1), or an individual who is debarred 

17 under subsection (a)(2), respectively.’’. 

18 (e) EXPANDED ACCESS TO UNAPPROVED THERAPIES

19 AND DIAGNOSTICS.—Section 561 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360bbb) is amend21 ed— 

22 (1) in subsections (a) through (d)— 

23 (A) by striking ‘‘or investigational devices’’ 

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1 tional devices, or investigational in vitro clinical 

2 tests’’; and 

3 (B) by striking ‘‘or investigational device’’ 

4 each place it appears (other than the second 

5 such place in paragraph (3)(A)) of subsection 

6 (c)) and inserting ‘‘, investigational device, or 

7 investigational in vitro clinical test’’; 

8 (2) in subsection (b)(4) by striking ‘‘or 520(g)’’ 

9 and inserting ‘‘, 520(g), or 587S’’ each place it ap10 pears; 

11 (3) in subsection (c)— 

12 (A) by amending the subsection heading to 

13 read: ‘‘TREATMENT INVESTIGATIONAL NEW

14 DRUG APPLICATIONS, TREATMENT INVESTIGA15 TIONAL DEVICE EXEMPTIONS, AND TREAT16 MENT INVESTIGATIONAL IN VITRO CLINICAL

17 TEST EXEMPTIONS.—’’; 

18 (B) in paragraph (3)(A), by striking ‘‘or 

19 investigational device exemption in effect under 

20 section 520(g)’’ and inserting ‘‘, investigational 

21 device exemption in effect under section 520(g), 

22 or investigational in vitro clinical test exemption 

23 under section 587S’’; 

24 (C) by striking ‘‘or treatment investiga25 tional device exemption’’ each place it appears 


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1 and inserting ‘‘, treatment investigational device 

2 exemption, or treatment investigational in vitro 

3 clinical test exemption’’; 

4 (D) in paragraph (5), by striking ‘‘or 

5 520(g)’’ and inserting ‘‘, 520(g), or 587S’’; and 

6 (E) in the matter following paragraph (7) 

7 by striking ‘‘or 520(g)’’ each place it appears 

8 and inserting ‘‘, 520(g) or 587S’’; and 

9 (4) by amending subsection (e) to read as fol10 lows: 

11 ‘‘(e) DEFINITIONS.—In this section, the terms ‘inves12 tigational drug’, ‘investigational device’, ‘investigational in 

13 vitro clinical test’, ‘treatment investigational new drug ap14 plication’, ‘treatment investigational device exemption’, 

15 and ‘treatment investigational in vitro clinical test exemp16 tion’ shall have the meanings given the terms in regula17 tions prescribed by the Secretary.’’. 

18 (f) OPTIMIZING GLOBAL CLINICAL TRIALS.—Section 

19 569A(b) of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 360bbb–8a(b)) is amended by inserting ‘‘an in 

21 vitro clinical test, as defined in subsection (ss) of such sec22 tion,’’ before ‘‘or a biological product’’. 

23 (g) PATIENT PARTICIPATION IN MEDICAL PRODUCT

24 DISCUSSION.—The heading of subsection (a) of section 

25 569C of the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 360bbb–8c) is amended by striking ‘‘Drugs and 

2 Devices’’ and inserting ‘‘Drugs, Devices, and In Vitro 

3 Clinical Tests’’. 

4 (h) REGULATIONS AND HEARINGS.—Section 

5 701(h)(1)(C)(ii) of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 371(h)(1)(C)(ii)) is amended by inserting 

7 ‘‘and in vitro clinical tests’’ after ‘‘devices’’. 

8 (i) RECORDS.—Section 703 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 373) is amended— 

10 (1) by inserting ‘‘in vitro clinical tests’’ after 

11 ‘‘devices’’ each place such term appears; and 

12 (2) by inserting ‘‘in vitro clinical test’’ after 

13 ‘‘device’’ each place such term appears. 

14 (j) FACTORY INSPECTION.—Section 704 of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) (other 

16 than subsection (g)) is amended— 

17 (1) by striking ‘‘drugs or devices’’ each place it 

18 appears and inserting ‘‘drugs, devices, or in vitro 

19 clinical tests’’; 

20 (2) in subsection (a)(1), in the fourth sentence, 

21 by striking ‘‘or chapter IX’’ and inserting ‘‘section 

22 587S, section 587M, section 587N, or chapter IX’’; 

23 (3) after making the amendments in para24 graphs (1) and (2), by inserting ‘‘in vitro clinical 

25 tests,’’ after ‘‘devices,’’ each place it appears; 


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1 (4) in subsection (a)(2)(B)— 

2 (A) by inserting ‘‘or in vitro clinical tests’’ 

3 after ‘‘prescribe or use devices’’; and 

4 (B) by inserting ‘‘or in vitro clinical tests’’ 

5 after ‘‘process devices’’; 

6 (5) by inserting ‘‘in vitro clinical test,’’ after 

7 ‘‘device,’’ each place it appears; 

8 (6) in subsection (e), by inserting ‘‘, or section 

9 587M, 587N, or 587S,’’ after ‘‘section 519 or 

10 520(g)’’; 

11 (7) in subsection (f)(3)— 

12 (A) in subparagraph (A), by striking ‘‘or’’ 

13 at the end; 

14 (B) in subparagraph (B), by striking the 

15 period at the end and inserting ‘‘; or’’; and 

16 (C) after subparagraph (B), by inserting 

17 the following: 

18 ‘‘(C) is accredited under section 587Q.’’; 

19 and 

20 (8) by adding at the end the following: 

21 ‘‘(i) For purposes of this section, the term ‘establish22 ment’ includes a laboratory performing an in vitro clinical 

23 test.’’. 


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1 (k) PUBLICITY.—Section 705(b) of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 375(b)) is amended 

3 by inserting ‘‘in vitro clinical tests,’’ after ‘‘devices,’’. 

4 (l) PRESUMPTION.—Section 709 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 379a) is amended by 

6 inserting ‘‘in vitro clinical test,’’ after ‘‘device,’’. 

7 (m) LISTING AND CERTIFICATION OF COLOR ADDI8 TIVES FOR FOODS, DRUGS, AND COSMETICS.—Section 

9 721(a) of the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 379e(a)) is amended— 

11 (1) in the matter preceding paragraph (1), by 

12 inserting ‘‘or in vitro clinical tests’’ after ‘‘or de13 vices’’; and 

14 (2) in the flush text following paragraph (2)— 

15 (A) by inserting ‘‘or an in vitro clinical 

16 test’’ after ‘‘a device’’; and 

17 (B) by inserting ‘‘or in vitro clinical tests’’ 

18 after ‘‘devices’’. 

19 (n) IMPORTS AND EXPORTS.—Section 801 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 

21 is amended— 

22 (1) in subsection (a)— 

23 (A) by inserting ‘‘in vitro clinical tests,’’ 

24 after ‘‘devices,’’ each place it appears; and 


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1 (B) by inserting ‘‘in the case of an in vitro 

2 clinical test, the test does not conform to the 

3 applicable requirements of section 587K, or’’ 

4 after ‘‘requirements of section 520(f), or’’; 

5 (2) in subsection (d)(3)— 

6 (A) in subparagraph (A)— 

7 (i) in the matter preceding clause (i), 

8 by inserting ‘‘and no component of an in 

9 vitro clinical test or other article of in vitro 

10 clinical test that requires further proc11 essing,’’ after ‘‘health-related purposes’’; 

12 (ii) in clause (i), by striking ‘‘drug or 

13 device’’ and inserting ‘‘drug, device, or in 

14 vitro clinical test’’; and 

15 (iii) in clause (i)(I), by inserting ‘‘in 

16 vitro clinical test,’’ after ‘‘device,’’; and 

17 (B) in subparagraph (B), by inserting ‘‘in 

18 vitro clinical test,’’ after ‘‘device,’’; 

19 (3) in subsection (e)(1), by inserting ‘‘in vitro 

20 clinical test,’’ after ‘‘device,’’; and 

21 (4) in subsection (o)— 

22 (A) by inserting ‘‘or in vitro clinical test’’ 

23 after ‘‘device’’; and 


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1 (B) by inserting ‘‘section 587J of each for2 eign establishment’’ after ‘‘section 510(i) of 

3 each establishment’’. 

4 (o) OFFICE OF INTERNATIONAL RELATIONS.—Sec5 tion 803 of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 383) is amended— 

7 (1) in subsection (b)— 

8 (A) in the matter preceding paragraph (1), 

9 by inserting ‘‘and in vitro clinical tests’’ after 

10 ‘‘devices’’; and 

11 (B) in paragraph (1), by inserting ‘‘quality 

12 requirements established under section 587K; 

13 and’’ at the end; and 

14 (2) in subsection (c)— 

15 (A) in paragraph (2), by inserting ‘‘in vitro 

16 clinical tests,’’ after ‘‘devices,’’; and 

17 (B) in paragraph (4), by inserting ‘‘or in 

18 vitro clinical tests’’ after ‘‘devices’’. 

19 (p) RECOGNITION OF FOREIGN GOVERNMENT IN20 SPECTIONS.—Section 809(a)(1) of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amend22 ed by inserting ‘‘, or of foreign establishments registered 

23 under section 587J’’ after ‘‘510(h)’’. 


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1 (q) FOOD AND DRUG ADMINISTRATION.—Section 

2 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 393(b)(2)) is amended— 

4 (1) in subparagraph (D), by striking ‘‘and’’ at 

5 the end; 

6 (2) in subparagraph (E), by striking the semi7 colon at the end and inserting ‘‘; and’’; and 

8 (3) by adding at the end the following: 

9 ‘‘(F) in vitro clinical tests are analytically 

10 and clinically valid;’’. 

11 (r) OFFICE OF WOMEN’S HEALTH.—Section 1011(b) 

12 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 399b(b)) is amended— 

14 (1) in paragraph (1), by inserting ‘‘in vitro clin15 ical tests,’’ after ‘‘devices,’’; and 

16 (2) in paragraph (4), by striking ‘‘and device 

17 manufacturers’’ and inserting ‘‘device manufactur18 ers, and in vitro clinical test developers,’’. 

19 (s) COUNTERMEASURE PROVISIONS OF THE PUBLIC

20 HEALTH SERVICE ACT.—Title III of the Public Health 

21 Service Act is amended— 

22 (1) in section 319F–1(a)(2)(A) (42 U.S.C. 

23 247d–6a(a)(2)(A))— 

24 (A) in the matter preceding clause (i)— 


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1 (i) by striking ‘‘or device’’ and insert2 ing ‘‘device’’; and 

3 (ii) by inserting ‘‘or an in vitro clin4 ical tests (as that term is defined in sec5 tion 201(ss) of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 321(ss))),’’ 

7 after ‘‘Act (21 U.S.C. 321(h))),’’; and 

8 (B) in each of clauses (ii) and (iii), by 

9 striking ‘‘or device’’ and inserting ‘‘device, or in 

10 vitro clinical test’’; 

11 (2) in section 319F–2(c)(1)(B) (42 U.S.C. 

12 247d–6b(c)(1)(B))— 

13 (A) by striking ‘‘or device’’ and inserting 

14 ‘‘device’’; and 

15 (B) by inserting ‘‘, or an in vitro clinical 

16 test (as that term is defined in section 201(ss) 

17 of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 321(ss)))’’ after ‘‘Act (21 U.S.C. 

19 321(h))),’’; and 

20 (3) in section 319F–3(i)(7) (42 U.S.C. 247d– 

21 6d(i)(7))— 

22 (A) in the matter preceding subparagraph 

23 (A)— 

24 (i) by striking ‘‘or device’’ and insert25 ing ‘‘device’’; and 


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1 (ii) by inserting ‘‘or an in vitro clin2 ical tests (as that term is defined in sec3 tion 201(ss) of the Federal Food, Drug, 

4 and Cosmetic Act (21 U.S.C. 321(ss))),’’ 

5 after ‘‘Act (21 U.S.C. 321(h))’’; 

6 (B) in subparagraph (A)— 

7 (i) by moving the margin of clause 

8 (iii) 2 ems to the left; and 

9 (ii) in clause (iii), by striking ‘‘or de10 vice’’ and inserting ‘‘device, or in vitro clin11 ical test’’; and 

12 (C) in subparagraph (B)— 

13 (i) in clause (i), by inserting ‘‘or the 

14 subject of a technology certification order’’ 

15 after ‘‘approved or cleared’’; and 

16 (ii) in clause (ii), by striking ‘‘or 

17 520(g)’’ and inserting ‘‘, 520(g), or 587S’’. 

18 SEC. 825. TRANSITION. 

19 (a) IMPLEMENTATION.— 

20 (1) EFFECTIVE DATE.— 

21 (A) IN GENERAL.—Except as otherwise 

22 provided in this section, the amendments made 

23 by this Act shall take effect on October 1, 2027 

24 (in this section and in subchapter J of chapter 

25 V of the Federal Food, Drug, and Cosmetic 


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1 Act, as added by this Act, referred to in this 

2 section as the ‘‘effective date of this Act’’). 

3 (B) EXCEPTIONS.— 

4 (i) IN GENERAL.—The Secretary of 

5 Health and Human Services (in this sec6 tion referred to as the ‘‘Secretary’’) may 

7 take the actions described in paragraph 

8 (3), and may expend such funds as the 

9 Secretary determines necessary to ensure 

10 an orderly transition, including prior to the 

11 effect date of this Act. 

12 (ii) IMPLEMENTATION OF CERTAIN

13 PROVISIONS.—The Secretary may imple14 ment sections 587J and 587U of the Fed15 eral Food, Drug, and Cosmetic Act (as 

16 added by section 3) beginning on October 

17 1, 2024, and such sections may take effect 

18 not earlier than October 1, 2027, to the 

19 extent and for the purposes indicated in 

20 such sections. In the case of a developer 

21 who, between October 1, 2024, and the ef22 fective date of this Act specified in sub23 paragraph (A), registers under such sec24 tion 587K with respect to an article that 

25 is an in vitro clinical test, such developer 


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1 shall not be required to register with re2 spect to such article under section 510 of 

3 such Act (21 U.S.C. 360). 

4 (2) ACTIONS.—The Secretary— 

5 (A) shall— 

6 (i) within 1 year of the date of enact7 ment of this Act, hold the public meetings 

8 described in section 587D(c) of the Fed9 eral Food, Drug, and Cosmetic Act (as 

10 added by section 3); 

11 (ii) within 3 years of the date of en12 actment of this Act, promulgate final regu13 lations required under the amendments 

14 made by this Act; and 

15 (iii) within 30 months of the date of 

16 enactment of this Act, issue final guidance 

17 on applicability requirements under 

18 amendments made by this Act; and 

19 (B) may take additional actions after the 

20 date of enactment that the Secretary deter21 mines necessary to ensure an orderly transition, 

22 which may not take effect until after the effec23 tive date, including— 


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1 (i) establishment of mitigating meas2 ures for an in vitro clinical test or category 

3 of in vitro clinical tests; and 

4 (ii) establishment of the comprehen5 sive test information system under section 

6 587T. 

7 (3) APPLICABILITY OF GUIDANCE AND REGULA8 TIONS.—Notwithstanding the date on which guid9 ance or regulations are issued under paragraph (3) 

10 and section 587K, no guidance or regulations issued 

11 pursuant to the amendments made by this Act shall 

12 be implemented or take effect until the effective date 

13 of this Act, as described in paragraph (1), except as 

14 otherwise specified in this Act (including the amend15 ments made by this Act). 

16 (b) APPLICATION OF AUTHORITIES TO IN VITRO

17 CLINICAL TESTS UNDER REVIEW ON THE EFFECTIVE

18 DATE OF THIS ACT.—For any in vitro clinical test, as 

19 defined in section 201(ss) of the Federal Food, Drug, and 

20 Cosmetic Act, as added by section 822, for which a sub21 mission for approval under section 515 of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 360e), clear23 ance under section 510(k) of such Act (21 U.S.C. 360(k)), 

24 authorization under section 513(f)(2) of such Act (21 

25 U.S.C. 360c(f)(2)), or licensure under section 351 of the 


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1 Public Health Service Act (42 U.S.C. 262) is pending on 

2 the effective date of this Act, including transitional in vitro 

3 clinical tests as described in subsection (c), the Secretary 

4 may review and take action on such submission after the 

5 effective date of this Act according to the statutory provi6 sion under which such submission was submitted. 

7 (c) APPLICATION OF AUTHORITIES TO TRANSI8 TIONAL IN VITRO CLINICAL TESTS.— 

9 (1) DEFINITION.—For purposes of this section, 

10 the term ‘‘transitional in vitro clinical test’’ means 

11 an in vitro clinical test, as defined in section 201(ss) 

12 of the Federal Food, Drug, and Cosmetic Act, as 

13 added by this Act, that— 

14 (A) is first offered for clinical use during 

15 the period beginning on the date of enactment 

16 of this Act and ending on the effective date of 

17 this Act; 

18 (B) is developed by a clinical laboratory 

19 certified by the Secretary under section 353 of 

20 the Public Health Service Act (42 U.S.C. 263a) 

21 that meets the requirements for performing 

22 high-complexity testing and performed— 

23 (i) in the same clinical laboratory in 

24 which the test was developed and for which 

25 a certification is still in effect under such 


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1 section 353 that meets the requirements to 

2 perform tests of high complexity; 

3 (ii) by another laboratory for which a 

4 certificate is in effect under such section 

5 353 that meets the requirements to per6 form tests of high complexity, is within the 

7 same corporate organization, and has com8 mon ownership by the same parent cor9 poration as the laboratory in which the 

10 test was developed; or 

11 (iii) in the case of a test that was de12 veloped by the Centers for Disease Control 

13 and Prevention or another laboratory a 

14 public health laboratory network coordi15 nated or managed by the Centers for Dis16 ease Control and Prevention, by a clinical 

17 laboratory for which a certificate is in ef18 fect under section 353 of such Act that 

19 meets the requirements to perform tests of 

20 high complexity, and that is within a pub21 lic health laboratory network coordinated 

22 or managed by the Centers for Disease 

23 Control and Prevention; and 

24 (C) when first offered, is not approved 

25 under section 515 of the Federal Food, Drug, 


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1 and Cosmetic Act, cleared under section 510(k) 

2 of such Act, authorized under section 513(f)(2) 

3 of such Act, subject to a humanitarian device 

4 exemption under section 520(m) of such Act 

5 (21 U.S.C. 360j(m)), subject to an exemption 

6 for investigation use under section 520(g) of 

7 such Act (21 U.S.C. 360j(g)), authorized under 

8 section 564 of such Act (21 U.S.C. 360bbb–3), 

9 or licensed under section 351 of the Public 

10 Health Service Act (42 U.S.C. 262). 

11 (2) PREMARKET REVIEW OR TECHNOLOGY CER12 TIFICATION.—A transitional in vitro clinical test 

13 that is the subject of an application for premarket 

14 review under section 587B of the Federal Food, 

15 Drug, and Cosmetic Act or technology certification 

16 application under section 587D of such Act, as 

17 added by this Act, may continue to be offered, sold, 

18 or distributed until completion of the Secretary’s re19 view of the premarket application or technology cer20 tification application, if such application is sub21 mitted no later than 90 days after the effective date 

22 of this Act. 

23 (3) TESTS APPROVED BY NEW YORK STATE.— 

24 Notwithstanding paragraph (2), a transitional in 

25 vitro clinical test that has been approved by the New 


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1 York State Department of Health may continue to 

2 be offered, sold, or distributed after the effective 

3 date if— 

4 (A) starting on the effective date of this 

5 Act, the in vitro clinical test complies with the 

6 requirements of subchapter J of the Federal 

7 Food, Drug, and Cosmetic Act, as added by 

8 this Act, except for sections 587B and design 

9 control provisions of section 587K; 

10 (B) each test report template for the test 

11 bears a statement of adequate prominence that 

12 reads as follows: ‘‘This in vitro clinical test was 

13 developed and first introduced prior to the ef14 fective date of the VALID Act of 2022. This 

15 test was approved by the New York State De16 partment of Health, but the test has not been 

17 reviewed by the Food and Drug Administra18 tion.’’; 

19 (C) a premarket application under section 

20 587B or technology certification application 

21 under section 587D is submitted no later 

22 than— 

23 (i) 5 years after the effective date of 

24 this Act, if the in vitro clinical test is ap25 proved by the New York State Department 


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1 of Health as a genetic testing molecular 

2 test, a microbiology molecular test, an on3 cology molecular test, or any other type of 

4 molecular test; or 

5 (ii) 2 years after the effective date of 

6 this Act, if the in vitro clinical test is ap7 proved by the New York State Department 

8 of Health as a type of test not described 

9 in clause (i); and 

10 (D) a test in compliance with this para11 graph (3) may continue to be offered, sold, or 

12 distributed until the completion of the Sec13 retary’s review of the premarket application or 

14 technology certification application referenced 

15 in subparagraph (C). 

16 (d) CONVERSION.— 

17 (1) DEEMED PREMARKET APPROVAL.—Begin18 ning on the effective date of this Act— 

19 (A) any in vitro clinical test (as defined in 

20 section 201(ss) of the Federal Food, Drug, and 

21 Cosmetic Act, as added by section 822) with a 

22 premarket approval under section 515 of the 

23 Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 360e) or a licensure under section 351 

25 of the Public Health Service Act (42 U.S.C. 


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1 262) is deemed to be approved pursuant to an 

2 application under section 587B(c) of the Fed3 eral Food, Drug, and Cosmetic Act, as added 

4 by this Act; and 

5 (B) any in vitro clinical test (as so defined) 

6 that was cleared under section 510(k) of the 

7 Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 360(k)) or authorized under section 

9 513(f)(2) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 360c(f)(2)) is deemed to 

11 be approved pursuant to an application under 

12 section 587B(d) of the Federal Food, Drug, 

13 and Cosmetic Act, as added by this Act. 

14 (2) DEEMED INVESTIGATIONAL USE EXEMP15 TION.—Any in vitro clinical test (as defined in sec16 tion 201(ss) of the Federal Food, Drug, and Cos17 metic Act, as added by section 822) that has an in18 vestigational device exemption in effect under section 

19 520(g) of the Federal Food, Drug, and Cosmetic Act 

20 (21 U.S.C. 360j(g)) is deemed to have an investiga21 tional use exemption in effect under section 587S of 

22 such Act, as added by this Act, beginning on the ef23 fective date of this Act. 

24 (3) DEEMED HUMANITARIAN DEVICE EXEMP25 TION.—Any in vitro clinical test (as defined in secVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00367 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 tion 201(ss) of the Federal Food, Drug, and Cos2 metic Act, as added by section 822) that has an ap3 proved humanitarian device exemption under section 

4 520(m) of such Act is deemed to have a humani5 tarian test exemption under section 587A(g) of such 

6 Act, as added by this Act, beginning on the effective 

7 date of this Act. 

8 (4) DEEMED DESIGNATED BREAKTHROUGH.— 

9 Any in vitro clinical test (as defined in section 

10 201(gg) of the Federal Food, Drug, and Cosmetic 

11 Act, as added by section 822) that has received a 

12 breakthrough device designation under section 

13 515B(e)(1)(D) of such Act (21 U.S.C. 360e– 

14 3(e)(1)(D)) is deemed to have a breakthrough in 

15 vitro clinical test designation under section 587C of 

16 such Act, as added by this Act, beginning on the ef17 fective date of this Act. 

18 (5) DEEMED REQUEST FOR INFORMAL FEED19 BACK.—With regard to any in vitro clinical test that 

20 is the subject of a pre-submission request described 

21 in the guidance, ‘‘Requests for Feedback and Meet22 ings for Medical Device Submissions: The Q-Submis23 sion Program’’, issued by the Food and Drug Ad24 ministration on January 6, 2021, such request is 

25 deemed to constitute a request for informal feedback 


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1 under section 587F of the Federal Food, Drug, and 

2 Cosmetic Act, as added by section 823, beginning on 

3 the effective date of this Act. 

4 (e) PREVIOUSLY CLASSIFIED DEVICES.—Notwith5 standing section 587 of the Federal Food, Drug, and Cos6 metic Act, as added by section 823, for purposes of sub7 chapter J of chapter V of such Act, as added by section 

8 823, the following apply: 

9 (1) In the case of an in vitro clinical test type 

10 that has been classified by the Secretary as a class 

11 I device pursuant to section 513 of such Act (21 

12 U.S.C. 360c), such in vitro clinical test shall be low13 risk, unless the in vitro clinical test is a test de14 scribed in section 510(l) or the test is redesignated 

15 by the Secretary pursuant to section 587F of such 

16 Act. 

17 (2) In the case of an in vitro clinical test type 

18 that has been classified by the Secretary as a class 

19 II device pursuant to section 513 of such Act (21 

20 U.S.C. 360c), such in vitro clinical test shall be 

21 moderate-risk, unless inaccurate results from the 

22 test would be immediately life threatening or the test 

23 is redesignated by the Secretary pursuant to section 

24 587F of such Act. 


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1 (3) In the case of an in vitro clinical test type 

2 that is a class III device pursuant to section 513 of 

3 such Act (21 U.S.C. 360c), such in vitro clinical test 

4 shall be high-risk, unless redesignated by the Sec5 retary pursuant to section 587F of such Act. 

6 SEC. 826. EMERGENCY USE AUTHORIZATION. 

7 (a) IN GENERAL.—Section 564 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend9 ed— 

10 (1) in subsection (a)— 

11 (A) in paragraphs (1) and (4)(C), by in12 serting ‘‘in vitro clinical test,’’ before ‘‘or bio13 logical product’’ each place such term appears; 

14 and 

15 (B) in paragraph (2)(A), by striking ‘‘or 

16 515’’ and inserting ‘‘515, or 587B’’; 

17 (2) in subsection (e)— 

18 (A) in paragraph (3)— 

19 (i) in subparagraph (B), by striking 

20 ‘‘and’’ at the end; 

21 (ii) in subparagraph (C), by striking 

22 the period and inserting ‘‘; and’’; and 

23 (iii) by adding at the end the fol24 lowing: 


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1 ‘‘(D) quality requirements (with respect to 

2 in vitro clinical tests) under section 587K.’’; 

3 and 

4 (B) in paragraph (4)— 

5 (i) in subparagraph (A), by striking ‘‘; 

6 or’’ and inserting a semicolon; 

7 (ii) in subparagraph (B), by striking 

8 the period and inserting ‘‘; or’’; and 

9 (iii) by adding at the end the fol10 lowing: 

11 ‘‘(C) with respect to in vitro clinical tests, 

12 requirements applicable to restricted in vitro 

13 clinical tests pursuant to section 587O.’’; 

14 (3) in subsection (m)— 

15 (A) in the subsection heading, by striking 

16 ‘‘LABORATORY TESTS ASSOCIATED WITH DE17 VICES’’ inserting ‘‘IN VITRO CLINICAL TESTS’’ 

18 after ‘‘DEVICES’’; and 

19 (B) in paragraph (1)— 

20 (i) by striking ‘‘to a device’’ and in21 serting ‘‘to an in vitro clinical test’’; and 

22 (ii) by striking ‘‘such device’’ and in23 serting ‘‘such in vitro clinical test’’. 

24 (b) EMERGENCY USE OF MEDICAL PRODUCTS.—Sec25 tion 564A(a)(2) of the Federal Food, Drug, and Cosmetic 


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1 Act (21 U.S.C. 360bbb–3a(a)(2)) is amended by inserting 

2 ‘‘in vitro clinical test,’’ after ‘‘device,’’. 

3 (c) PRODUCTS HELD FOR EMERGENCY USE.—Sec4 tion 564B(2) of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 360bbb–3b(2)) is amended— 

6 (1) in subparagraph (A), by striking ‘‘or 515’’ 

7 and inserting ‘‘515, or 587B’’; and 

8 (2) in subparagraph (B), by striking ‘‘or 520’’ 

9 and inserting 520, or 587S. 

10 SEC. 827. ANTIMICROBIAL SUSCEPTIBILITY TESTS. 

11 Section 511A of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 360a–2) is amended— 

13 (1) in subsection (a)(1)(C)— 

14 (A) by striking ‘‘clear under section 

15 510(k), classify under section 513(f)(2), or ap16 prove under section 515’’ and inserting ‘‘ap17 prove under section 587B, exempt from pre18 market review under section 587C, or grant a 

19 technology certification order under section 

20 587D’’; and 

21 (B) by striking ‘‘testing devices’’ and in22 serting ‘‘in vitro clinical tests’’; 

23 (2) in subsection (c)(5), by striking ‘‘drug or 

24 device’’ each place it appears and inserting ‘‘drug, 

25 device, or in vitro clinical test’’; 


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1 (3) in subsection (e)— 

2 (A) in the heading, by striking ‘‘TESTING

3 DEVICES’’ and inserting ‘‘IN VITRO CLINICAL

4 TESTS’’; 

5 (B) in paragraph (1)— 

6 (i) by striking ‘‘510, 513, and 515,’’ 

7 and inserting ‘‘587B, and 587D’’; 

8 (ii) by striking ‘‘antimicrobial suscep9 tibility testing device’’ and inserting ‘‘anti10 microbial susceptibility in vitro clinical 

11 test’’; and 

12 (iii) by striking ‘‘such device’’ and in13 serting ‘‘such in vitro clinical test’’; and 

14 (C) in paragraph (2)— 

15 (i) in the heading, by striking ‘‘TEST16 ING DEVICES’’ and inserting ‘‘IN VITRO

17 CLINICAL TESTS’’; 

18 (ii) in subparagraphs (A) and (B) 

19 (other than clause (iii) of such subpara20 graph (B)), by striking ‘‘device’’ each place 

21 it appears and inserting ‘‘in vitro clinical 

22 test’’; 

23 (iii) in subparagraph (B)(iii), by strik24 ing ‘‘a device’’ and inserting ‘‘an in vitro 

25 clinical test’’; and 


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1 (iv) by amending subparagraph (C) to 

2 read as follows: 

3 ‘‘(C) The antimicrobial susceptibility in 

4 vitro clinical test meets all other requirements 

5 to be approved under section 587B, exempted 

6 from premarket review under section 587C, or 

7 offered under a technology certification order 

8 under section 587D.’’; 

9 (4) in subsection (f), by amending paragraph 

10 (1) to read as follows: 

11 ‘‘(1) The term ‘antimicrobial susceptibility in 

12 vitro clinical test’ means an in vitro clinical test that 

13 utilizes susceptibility test interpretive criteria to de14 termine and report the in vitro susceptibility of cer15 tain microorganisms to a drug (or drugs).’’; and 

16 (5) in subsection (g)(2)— 

17 (A) by amending the matter preceding sub18 paragraph (A) to read as follows: 

19 ‘‘(2) with respect to approving an application 

20 under section 587B or granting a technology certifi21 cation order under section 587D—’’; and 

22 (B) in subparagraph (A)— 

23 (i) by striking ‘‘device’’ and inserting 

24 ‘‘in vitro clinical test’’; and 


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1 (ii) by striking ‘‘antimicrobial suscep2 tibility testing device’’ and inserting ‘‘anti3 microbial susceptibility in vitro clinical 

4 test’’. 

5 SEC. 828. COMBINATION PRODUCTS. 

6 (a) IN GENERAL.—Section 503(g) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is 

8 amended— 

9 (1) in paragraph (1)— 

10 (A) in subparagraph (A), by striking ‘‘or 

11 biological product’’ and inserting ‘‘in vitro clin12 ical test, or biological product (except for a 

13 product constituted of a device and an in vitro 

14 clinical test)’’; 

15 (B) in subparagraph (B), by adding at the 

16 end the following: ‘‘For purposes of this Act, a 

17 product that constitutes a combination of a 

18 drug and an in vitro clinical test is not a com19 bination product within the meaning of this 

20 subsection.’’; and 

21 (C) in subparagraph (D)(ii)— 

22 (i) by inserting ‘‘or in vitro clinical 

23 test’’ after ‘‘device’’; and 

24 (ii) by inserting ‘‘and in vitro clinical 

25 tests’’ before ‘‘shall’’; 


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1 (2) in paragraph (3), by striking ‘‘safety and 

2 effectiveness or substantial equivalence’’ and insert3 ing ‘‘safety and effectiveness, substantial equiva4 lence, or analytical validity and clinical validity’’ be5 fore ‘‘for the approved constituent part’’; 

6 (3) in paragraph (4)— 

7 (A) in subparagraph (A), by striking ‘‘or 

8 513(f)(2) (submitted in accordance with para9 graph (5))’’ and inserting ‘‘513(f)(2) (sub10 mitted in accordance with paragraph (5)), 

11 587B, or 587D, or an exempt test under sec12 tion 587C, as applicable’’; and 

13 (B) in subparagraph (B), by inserting ‘‘, 

14 587B, or 587D’’ after ‘‘section 515’’; 

15 (4) in paragraph (5)(A), by striking ‘‘or 

16 510(k)’’ and inserting ‘‘, 510(k), 587B, or 587D’’; 

17 (5) in paragraph (7), by striking ‘‘or substan18 tial equivalence’’ and inserting ‘‘, substantial equiva19 lence, or analytical validity and clinical validity’’; 

20 (6) in paragraph (8), by adding at the end the 

21 following: 

22 ‘‘(I) This paragraph shall not apply to a 

23 product constituted of a device and an in vitro 

24 clinical test.’’; and 

25 (7) in paragraph (9)— 


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1 (A) in subparagraph (C)(i), by striking ‘‘or 

2 520(g)’’ and inserting ‘‘520(g), 587B, or 

3 587D’’; and 

4 (B) in subparagraph (D), by striking ‘‘or 

5 520’’ and inserting ‘‘520, 587B, or 587D’’. 

6 (b) CLASSIFICATION OF PRODUCTS.—Section 563 of 

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 360bbb–2) is amended by adding at the end the following: 

9 ‘‘(d) EXEMPTION.—This section shall not apply to a 

10 product constituted of a device and an in vitro clinical 

11 test.’’. 

12 SEC. 829. RESOURCES. 

13 (a) FINDINGS.—Congress finds that the fees author14 ized by this section will be dedicated to meeting the goals 

15 identified in the letters from the Secretary of Health and 

16 Human Services to the Committee on Health, Education, 

17 Labor, and Pensions of the Senate and the Committee on 

18 Energy and Commerce of the House of Representatives, 

19 as set forth in the Congressional Record. 

20 (b) AUTHORIZATION OF APPROPRIATIONS.—For pur21 poses of funding implementation of subchapter J of title 

22 V of the Federal Food, Drug, and Cosmetic Act, as added 

23 by this Act, including undertaking activities for the devel24 opment of regulations and guidances, hiring of necessary 

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1 ment this subchapter in a timely, effective, and efficient 

2 manner there is authorized to be appropriated 

3 $480,000,000. 

4 (c) ESTABLISHMENT OF USER FEE PROGRAM.— 

5 (1) DEVELOPMENT OF USER FEES FOR IN

6 VITRO CLINICAL TESTS.— 

7 (A) IN GENERAL.—Beginning not later 

8 than October 1, 2021, the Secretary of Health 

9 and Human Services (in this section referred to 

10 as the ‘‘Secretary’’) shall develop recommenda11 tions to present to Congress with respect to the 

12 goals, and plans for meeting the goals, for the 

13 process for the review of in vitro clinical test 

14 submissions and applications under subchapter 

15 J of chapter V of the Federal Food, Drug, and 

16 Cosmetic Act, as added by this Act, for the first 

17 5 fiscal years after fiscal year 2022. In devel18 oping such recommendations, the Secretary 

19 shall consult with— 

20 (i) the Committee on Health, Edu21 cation, Labor, and Pensions of the Senate; 

22 (ii) the Committee on Energy and 

23 Commerce of the House of Representa24 tives; 

25 (iii) scientific and academic experts; 


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1 (iv) health care professionals; 

2 (v) representatives of patient and con3 sumer advocacy groups; and 

4 (vi) the regulated industry. 

5 (B) PRIOR PUBLIC INPUT.—Prior to begin6 ning negotiations with the regulated industry 

7 on the authorization of such subchapter J, the 

8 Secretary shall— 

9 (i) publish a notice in the Federal 

10 Register requesting public input on the au11 thorization of user fees; 

12 (ii) hold a public meeting at which the 

13 public may present its views on the author14 ization, including specific suggestions for 

15 the recommendations submitted under sub16 paragraph (E); 

17 (iii) provide a period of 30 days after 

18 the public meeting to obtain written com19 ments from the public suggesting changes 

20 to such subchapter J; and 

21 (iv) publish any comments received 

22 under clause (iii) on the website of the 

23 Food and Drug Administration. 

24 (C) PERIODIC CONSULTATION.—Not less 

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1 tiations with the regulated industry, the Sec2 retary shall hold discussions with representa3 tives of patient and consumer advocacy groups 

4 to continue discussions of the authorization 

5 under such subchapter J and to solicit sugges6 tions to be included in the recommendations 

7 transmitted to Congress under subparagraph 

8 (E). 

9 (D) PUBLIC REVIEW OF RECOMMENDA10 TIONS.—After negotiations with the regulated 

11 industry, the Secretary shall— 

12 (i) present the recommendations de13 veloped under subparagraph (A) to the 

14 Committee on Health, Education, Labor, 

15 and Pensions of the Senate and the Com16 mittee on Energy and Commerce of the 

17 House of Representatives; 

18 (ii) publish such recommendations in 

19 the Federal Register; 

20 (iii) provide for a period of 30 days 

21 for the public to provide written comments 

22 on such recommendations; 

23 (iv) hold a meeting at which the pub24 lic may present its views on such rec25 ommendations; and 


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1 (v) after consideration of such public 

2 views and comments, revise such rec3 ommendations as necessary. 

4 (E) TRANSMITTAL OF RECOMMENDA5 TIONS.— 

6 (i) IN GENERAL.—Not later than Jan7 uary 15, 2027, the Secretary shall trans8 mit to Congress the revised recommenda9 tions under subparagraph (A), a summary 

10 of the views and comments received under 

11 such subparagraph, and any changes made 

12 to the recommendations in response to 

13 such views and comments. 

14 (ii) RECOMMENDATION REQUIRE15 MENTS.—The recommendations trans16 mitted under this subparagraph shall— 

17 (I) include the number of full18 time equivalent employees per fiscal 

19 year that are agreed to be hired to 

20 carry out the goals included in such 

21 recommendations for each year of the 

22 5-year period; 

23 (II) provide that the amount of 

24 operating reserve balance in the user 

25 fee program established under this 


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1 section is not more than the equiva2 lent of 10 weeks of operating reserve; 

3 (III) require the development of 

4 a strategic plan for any surplus within 

5 the operating reserve account above 

6 the 10-week operating reserve within 

7 2 years of the establishment of the 

8 program; 

9 (IV) include an operating reserve 

10 adjustment such that, if the Secretary 

11 has an operating reserve balance in 

12 excess of 10 weeks of such operating 

13 reserves, the Secretary shall decrease 

14 such fee revenue and fees to provide 

15 for not more than 10 weeks of such 

16 operating reserves; 

17 (V) if an adjustment is made as 

18 described in subclause (IV), provide 

19 the rationale for the amount of the 

20 decrease in fee revenue and fees shall 

21 be contained in the Federal Register; 

22 and 

23 (VI) provide that the fees as24 sessed and collected for the full-time 

25 equivalent employees at the Center for 


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1 Devices and Radiological Health, with 

2 respect to which the majority of time 

3 reporting data indicates are dedicated 

4 to the process for the review of in 

5 vitro clinical test submissions and ap6 plications under paragraph (5), are 

7 not supported by the funds authorized 

8 to be collected and assessed under sec9 tion 738 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 379j). 

11 (F) PUBLICATION OF RECOMMENDA12 TIONS.—The Secretary shall publish on the 

13 website of the Food and Drug Administration 

14 the revised recommendations under subpara15 graph (A), a summary of the views and com16 ments received under subparagraphs (B) 

17 through (D), and any changes made to the rec18 ommendations originally proposed by the Sec19 retary in response to such views and comments. 

20 (G) MINUTES OF NEGOTIATION MEET21 INGS.— 

22 (i) PUBLIC AVAILABILITY.—The Sec23 retary shall make publicly available, on the 

24 website of the Food and Drug Administra25 tion, minutes of all negotiation meetings 


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1 conducted under this subsection between 

2 the Food and Drug Administration and the 

3 regulated industry not later than 30 days 

4 after such meeting. 

5 (ii) CONTENT.—The minutes de6 scribed under clause (i) shall summarize 

7 any substantive proposal made by any 

8 party to the negotiations, any significant 

9 controversies or differences of opinion dur10 ing the negotiations, and the resolution of 

11 any such controversy or difference of opin12 ion. 

13 (2) ESTABLISHMENT OF USER FEE PRO14 GRAM.—Effective on October 1, 2027, provided that 

15 the Secretary transmits the recommendations under 

16 paragraph (1)(E), the Secretary is authorized to col17 lect user fees relating to the review of in vitro clin18 ical test submissions and applications under sub19 chapter J of chapter V of the Federal Food, Drug, 

20 and Cosmetic Act, as added by this Act. Fees under 

21 such program shall be assessed and collected only if 

22 the requirements under paragraph (4) are met. 

23 (3) AUDIT.— 

24 (A) IN GENERAL.—On the date that is 2 

25 years after first receiving a user fee applicable 


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1 to submission of an in vitro clinical test applica2 tion submitted under subchapter J of chapter V 

3 of the Federal Food, Drug, and Cosmetic Act, 

4 as added by this Act, and on a biennial basis 

5 thereafter, the Secretary shall perform an audit 

6 of the costs of reviewing such applications 

7 under such subchapter J. Such an audit shall 

8 compare the costs of reviewing such applica9 tions under such subchapter J to the amount of 

10 the user fee applicable to such applications. 

11 (B) ALTERATION OF USER FEE.—If the 

12 audit performed under subparagraph (A) indi13 cates that the user fees applicable to applica14 tions submitted under such subchapter J exceed 

15 49 percent of the costs of reviewing such appli16 cations, the Secretary shall alter the user fees 

17 applicable to applications submitted under such 

18 subchapter J such that the user fees do not ex19 ceed such percentage. 

20 (C) ACCOUNTING STANDARDS.—The Sec21 retary shall perform an audit under subpara22 graph (A) in conformance with the accounting 

23 principles, standards, and requirements pre24 scribed by the Comptroller General of the 

25 United States under section 3511 of title 31, 


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1 United States Code, to ensure the validity of 

2 any potential variability. 

3 (4) CONDITIONS.—The user fee program de4 scribed in this subsection shall take effect only if the 

5 Food and Drug Administration issues draft guidance 

6 related to the review requirements for in vitro diag7 nostic tests that would be subject to premarket re8 view under section 587B of the Federal Food, Drug, 

9 and Cosmetic Act, as added by section 823, the re10 view requirements for test categories eligible for 

11 technology certification under section 587D of such 

12 Act, as added by section 823, and the parameters 

13 for the test categories that would be exempt from 

14 any review under subchapter J of chapter V of such 

15 Act. 

16 (5) USER FEE PROGRAM DEFINITIONS AND RE17 SOURCE REQUIREMENTS.— 

18 (A) IN GENERAL.—The term ‘‘process for 

19 the review of in vitro clinical test submissions 

20 and applications’’ means the following activities 

21 of the Secretary with respect to the review of in 

22 vitro clinical test premarket and technology cer23 tification applications including supplements for 

24 such applications: 


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1 (i) The activities necessary for the re2 view of premarket applications, premarket 

3 reports, technology certification applica4 tions, and supplements to such applica5 tions. 

6 (ii) Actions related to submissions in 

7 connection with in vitro clinical test devel8 opment, the issuance of action letters that 

9 allow the marketing of in vitro clinical 

10 tests or which set forth in detail the spe11 cific deficiencies in such applications, re12 ports, supplements, or submissions and, 

13 where appropriate, the actions necessary to 

14 support the development of in vitro clinical 

15 tests. 

16 (iii) The inspection of manufacturing 

17 establishments and other facilities under18 taken as part of the Secretary’s review of 

19 pending premarket applications, technology 

20 certifications, and supplements. 

21 (iv) Monitoring of research conducted 

22 in connection with the review of such appli23 cations, supplements, and submissions. 

24 (v) Review of in vitro clinical test ap25 plications subject to section 351 of the 


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1 Public Health Service Act (42 U.S.C. 262) 

2 and activities conducted in anticipation of 

3 the submission of such applications for in4 vestigational use under section 587S of the 

5 Federal Food, Drug, and Cosmetic Act (as 

6 added by section 823). 

7 (vi) The development of guidance, pol8 icy documents, or regulations to improve 

9 the process for the review of premarket ap10 plications, technology certification applica11 tions, and supplements. 

12 (vii) The development of voluntary 

13 test methods, consensus standards, or 

14 mandatory performance standards in con15 nection with the review of such applica16 tions, supplements, or submissions and re17 lated activities. 

18 (viii) The provision of technical assist19 ance to in vitro clinical test developers in 

20 connection with the submission of such ap21 plications, reports, supplements, or submis22 sions. 

23 (ix) Any activity undertaken in con24 nection with the initial classification or re25 classification of an in vitro clinical test in 


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1 connection with any requirement for ap2 proval or eligibility for an exemption from 

3 premarket review of an in vitro clinical 

4 test. 

5 (x) Any activity undertaken in connec6 tion with making a pathway determination 

7 of an in vitro clinical test, including the 

8 identification, establishment, and imple9 mentation of mitigation measures. 

10 (xi) Evaluation of postmarket studies 

11 required as a condition of an approval of 

12 a premarket application of an in vitro clin13 ical test and ensuring such studies are con14 ducted as required. 

15 (xii) Any activity undertaken in con16 nection with ensuring in vitro clinical tests 

17 marketed under an exemption from pre18 market review pursuant to section 587C or 

19 587G meet the criteria for such exemption 

20 and the applicable standard. 

21 (xiii) Compiling, developing, and re22 viewing information on in vitro clinical 

23 tests necessary to identify issues with the 

24 ability of in vitro clinical tests to meet the 

25 applicable standard, as applicable. 


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1 (B) RESOURCE REQUIREMENTS.—Fees col2 lected and assessed under this section shall be 

3 used for the process for the review of in vitro 

4 clinical test applications, as described in sub5 paragraph (A), and shall— 

6 (i) be subject to the limitation under 

7 section 738(g)(3) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 

9 379j(g)(3)), in the same manner that fees 

10 collected and assessed under section 

11 737(9)(C) of such Act (21 U.S.C. 

12 379i(9)(C)) are subject to such limitation; 

13 (ii) include travel expenses for officers 

14 and employees of the Food and Drug Ad15 ministration only if the Secretary deter16 mines that such travel is directly related to 

17 an activity described in subparagraph (A); 

18 and 

19 (iii) not be allocated to purposes de20 scribed under section 722(a) of the Con21 solidated Appropriations Act, 2018 (Public 

22 Law 115–141). 

23 (d) REPORTS.— 

24 (1) PERFORMANCE REPORT.— 

25 (A) IN GENERAL.— 


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1 (i) GENERAL REQUIREMENTS.—Be2 ginning with fiscal year 2027, for each fis3 cal year for which fees are collected under 

4 this section, the Secretary shall prepare 

5 and submit to the Committee on Health, 

6 Education, Labor, and Pensions of the 

7 Senate and the Committee on Energy and 

8 Commerce of the House of Representatives 

9 annual reports concerning the progress of 

10 the Food and Drug Administration in 

11 achieving the goals identified in the rec12 ommendations transmitted to Congress by 

13 the Secretary pursuant to subsection 

14 (b)(1)(E) during such fiscal year and the 

15 future plans of the Food and Drug Admin16 istration for meeting the goals. 

17 (ii) ADDITIONAL INFORMATION.—Be18 ginning with fiscal year 2021, the annual 

19 report under this subparagraph shall in20 clude the progress of the Food and Drug 

21 Administration in achieving the goals, and 

22 future plans for meeting the goals, includ23 ing— 

24 (I) the number of premarket ap25 plications filed under section 587B of 


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1 the Federal Food, Drug, and Cos2 metic Act during the applicable fiscal 

3 year; 

4 (II) the number of technology 

5 certification applications submitted 

6 under section 587D of the Federal 

7 Food, Drug, and Cosmetic Act during 

8 the applicable fiscal year for each re9 view division; 

10 (III) the number of breakthrough 

11 designations under section 587I of the 

12 Federal Food, Drug, and Cosmetic 

13 Act during the applicable fiscal year; 

14 and 

15 (IV) the number of information 

16 requests requested by the Secretary 

17 pursuant to section 587G(d) of such 

18 Act. 

19 (iii) REAL-TIME REPORTING.— 

20 (I) IN GENERAL.—Not later than 

21 30 calendar days after the end of the 

22 second quarter of fiscal year 2027, 

23 and not later than 30 calendar days 

24 after the end of each quarter of each 

25 fiscal year thereafter, the Secretary 


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1 shall post the data described in sub2 clause (II) on the website of the Food 

3 and Drug Administration for such 

4 quarter and on a cumulative basis for 

5 such fiscal year, and may remove du6 plicative data from the annual report 

7 under this subparagraph. 

8 (II) DATA.—The Secretary shall 

9 post the following data in accordance 

10 with subclause (I): 

11 (aa) The number and titles 

12 of draft and final regulations on 

13 topics related to the process for 

14 the review of in vitro clinical test 

15 submissions and applications, 

16 and whether such guidances were 

17 required by statute or pursuant 

18 to the recommendations trans19 mitted to Congress by the Sec20 retary pursuant to subsection 

21 (b)(1)(E). 

22 (bb) The number and titles 

23 of draft and final guidance on 

24 topics related to the process for 

25 the review of in vitro clinical test 


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1 submissions and applications, 

2 and whether such guidances were 

3 issued as required by statute or 

4 pursuant to the recommendations 

5 transmitted to Congress by the 

6 Secretary pursuant to subsection 

7 (c)(1)(E). 

8 (cc) The number and titles 

9 of public meetings held on topics 

10 related to the process for the re11 view of in vitro clinical tests, and 

12 if such meetings were required by 

13 statute or pursuant to the rec14 ommendations transmitted to 

15 Congress by the Secretary pursu16 ant to subsection (c)(1)(E). 

17 (iv) RATIONALE FOR IVCT USER FEE

18 PROGRAM CHANGES.—Beginning with fis19 cal year 2027, the Secretary shall include 

20 in the annual performance report under 

21 paragraph (1)— 

22 (I) data, analysis, and discussion 

23 of the changes in the number of full24 time equivalents hired as agreed upon 

25 in the recommendations transmitted 


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1 to Congress by the Secretary pursuant 

2 to subsection (b)(1)(E) and the num3 ber of full-time equivalents funded by 

4 budget authority at the Food and 

5 Drug Administration by each division 

6 within the Center for Devices and Ra7 diological Health, the Center for Bio8 logics Evaluation and Research, the 

9 Office of Regulatory Affairs, and the 

10 Office of the Commissioner; 

11 (II) data, analysis, and discus12 sion of the changes in the fee revenue 

13 amounts and costs for the process for 

14 the review of in vitro clinical test sub15 missions and applications, including 

16 identifying drivers of such changes; 

17 and 

18 (III) for each of the Center for 

19 Devices and Radiological Health, the 

20 Center for Biologics Evaluation and 

21 Research, the Office of Regulatory Af22 fairs, and the Office of the Commis23 sioner, the number of employees for 

24 whom time reporting is required and 


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1 the number of employees for whom 

2 time reporting is not required. 

3 (v) ANALYSIS.—For each fiscal year, 

4 the Secretary shall include in the report 

5 under clause (i) an analysis of the fol6 lowing: 

7 (I) The difference between the 

8 aggregate number of premarket appli9 cations filed under section 587B or 

10 section 587D of the Federal Food, 

11 Drug, and Cosmetic Act and the ag12 gregate number of major deficiency 

13 letters, not approvable letters, and de14 nials for such applications issued by 

15 the agency, accounting for— 

16 (aa) the number of applica17 tions filed under each of sections 

18 587B and 587D of the Federal 

19 Food, Drug, and Cosmetic Act 

20 during one fiscal year for which a 

21 decision is not scheduled to be 

22 made until the following fiscal 

23 year; and 

24 (bb) the aggregate number 

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1 tions 587B and 587D of the 

2 Federal Food, Drug, and Cos3 metic Act for each fiscal year 

4 that did not meet the goals as 

5 identified by the recommenda6 tions transmitted to Congress by 

7 the Secretary pursuant to sub8 section (b)(1)(E). 

9 (II) Relevant data to determine 

10 whether the Center for Devices and 

11 Radiological Health has met perform12 ance enhancement goals identified by 

13 the recommendations transmitted to 

14 Congress by the Secretary pursuant to 

15 subsection (b)(1)(E). 

16 (III) The most common causes 

17 and trends for external or other cir18 cumstances affecting the ability of the 

19 Food and Drug Administration to 

20 meet review time and performance en21 hancement goals identified by the rec22 ommendations transmitted to Con23 gress by the Secretary pursuant to 

24 subsection (b)(1)(E). 


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1 (B) PUBLICATION.—With regard to infor2 mation to be reported by the Food and Drug 

3 Administration to industry on a quarterly and 

4 annual basis pursuant to recommendations 

5 transmitted to Congress by the Secretary pur6 suant to subsection (b)(1)(E), the Secretary 

7 shall make such information publicly available 

8 on the website of the Food and Drug Adminis9 tration not later than 60 days after the end of 

10 each quarter or 120 days after the end of each 

11 fiscal year, respectively, to which such informa12 tion applies. 

13 (C) UPDATES.—The Secretary shall in14 clude in each report under subparagraph (A) 

15 information on all previous cohorts for which 

16 the Secretary has not given a complete response 

17 on all in vitro clinical test premarket applica18 tions and technology certification orders and 

19 supplements, premarket, and technology certifi20 cation notifications in the cohort. 

21 (2) CORRECTIVE ACTION REPORT.—Beginning 

22 with fiscal year 2022, for each fiscal year for which 

23 fees are collected under this section, the Secretary 

24 shall prepare and submit a corrective action report 

25 to the Committee on Health, Education, Labor, and 


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1 Pensions and the Committee on Appropriations of 

2 the Senate and the Committee on Energy and Com3 merce and the Committee on Appropriations of the 

4 House of Representatives. The report shall include 

5 the following information, as applicable: 

6 (A) GOALS MET.—For each fiscal year, if 

7 the Secretary determines, based on the analysis 

8 under paragraph (1)(A)(v), that each of the 

9 goals identified by the recommendations trans10 mitted to Congress by the Secretary pursuant 

11 to subsection (b)(1)(E) for the applicable fiscal 

12 year have been met, the corrective action report 

13 shall include recommendations on ways in which 

14 the Secretary can improve and streamline the in 

15 vitro clinical test premarket application and 

16 technology certification review process. 

17 (B) GOALS MISSED.—For each of the goals 

18 identified by the letters described in rec19 ommendations transmitted to Congress by the 

20 Secretary pursuant to subsection (b)(1)(E) for 

21 the applicable fiscal year that the Secretary de22 termines to not have been met, the corrective 

23 action report shall include— 

24 (i) a justification for such determina25 tion; 


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1 (ii) a description of the types of cir2 cumstances, in the aggregate, under which 

3 applications or reports submitted under 

4 sections 587B and 587D of the Federal 

5 Food, Drug, and Cosmetic Act missed the 

6 review goal times but were approved dur7 ing the first cycle review, as applicable; 

8 (iii) a summary and any trends with 

9 regard to the circumstances for which a re10 view goal was missed; and 

11 (iv) the performance enhancement 

12 goals that were not achieved during the 

13 previous fiscal year and a description of ef14 forts the Food and Drug Administration 

15 has put in place for the fiscal year in 

16 which the report is submitted to improve 

17 the ability of such agency to meet each 

18 such goal for the such fiscal year. 

19 (3) FISCAL REPORT.—For fiscal years 2027 

20 and annually thereafter, not later than 120 days 

21 after the end of each fiscal year during which fees 

22 are collected under this subpart, the Secretary shall 

23 prepare and submit to the Committee on Health, 

24 Education, Labor, and Pensions of the Senate and 

25 the Committee on Energy and Commerce of the 


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1 House of Representatives, a report on the implemen2 tation of the authority for such fees during such fis3 cal year and the use, by the Food and Drug Admin4 istration, of the fees collected during such fiscal year 

5 for which the report is made. 

6 (A) CONTENTS.—Such report shall include 

7 expenditures delineated by budget authority and 

8 user fee dollars related to administrative ex9 penses and information technology infrastruc10 ture contracts and expenditures. 

11 (B) OPERATING RESERVE.—Such report 

12 shall provide the amount of operating reserve 

13 balance available each year, and any planned al14 locations or obligations of such balance that is 

15 above 10 weeks of operating reserve for the pro16 gram. 

17 (4) PUBLIC AVAILABILITY.—The Secretary 

18 shall make the reports required under paragraphs 

19 (1) through (3) available to the public on the website 

20 of the Food and Drug Administration. 

21 (5) ENHANCED COMMUNICATION.— 

22 (A) COMMUNICATIONS WITH CONGRESS.— 

23 Each fiscal year, as applicable and requested, 

24 representatives from the Centers with expertise 

25 in the review of in vitro clinical tests shall meet 


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1 with representatives from the Committee on 

2 Health, Education, Labor, and Pensions of the 

3 Senate and the Committee on Energy and Com4 merce of the House of Representatives to report 

5 on the contents described in the reports under 

6 this section. 

7 (B) PARTICIPATION IN CONGRESSIONAL

8 HEARING.—Each fiscal year, as applicable and 

9 requested, representatives from the Food and 

10 Drug Administration shall participate in a pub11 lic hearing before the Committee on Health, 

12 Education, Labor, and Pensions of the Senate 

13 and the Committee on Energy and Commerce 

14 of the House of Representatives, to report on 

15 the contents described in the reports under this 

16 section. Such hearing shall occur not later than 

17 120 days after the end of each fiscal year for 

18 which fees are collected under this section. 

19 SEC. 830. AUTHORIZATION OF APPROPRIATIONS. 

20 For purposes of funding implementation of this sub21 title (including the amendments made by this subtitle), in22 cluding undertaking activities for the development of regu23 lations and guidances, hiring of necessary staff, and the 

24 development of technology systems to implement this sub25 title (including the amendments made by this subtitle) in 


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1 a timely, effective, and efficient manner, there is author2 ized to be appropriated not more than $480,000,000, to 

3 remain available through the end of fiscal year 2027. 

4 TITLE IX—OTHER PROVISIONS 

5 SEC. 901. FACILITIES MANAGEMENT. 

6 (a) PDUFA AUTHORITY.—Section 736(g)(2) of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 379h(g)(2))— 

9 (1) in subparagraph (A)(ii)— 

10 (A) by striking ‘‘shall be available to de11 fray’’ and inserting the following: ‘‘shall be 

12 available— 

13 ‘‘(I) for fiscal year 2023, to de14 fray’’; 

15 (B) by striking the period and inserting ‘‘; 

16 and’’; and 

17 (C) by adding at the end the following: 

18 ‘‘(II) for fiscal year 2024 and 

19 each subsequent fiscal year, to defray 

20 the costs of the resources allocated for 

21 the process for the review of human 

22 drug applications (including such 

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1 ices to be engaged in such process), 

2 only if the sum of the amounts allo3 cated by the Secretary for such costs, 

4 excluding costs paid from fees col5 lected under this section, plus other 

6 costs for the maintenance, renovation, 

7 and repair of facilities and acquisition, 

8 maintenance, and repair of fixtures, 

9 furniture, and other necessary mate10 rials and supplies in connection with 

11 the process for the review of human 

12 drug applications, is no less than the 

13 amount allocated for such costs, ex14 cluding any such costs paid from fees 

15 collected under this section, for fiscal 

16 year 1997, multiplied by the adjust17 ment factor.’’; and 

18 (2) in subparagraph (B), by striking ‘‘for the 

19 process for the review of human drug applications’’ 

20 and inserting ‘‘as described in subclause (I) or (II) 

21 of such subparagraph, as applicable’’. 

22 (b) BSUFA AUTHORITY.—Section 744H(f)(2) of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

24 52(f)(2)) is amended— 

25 (1) in subparagraph (B)(i)— 


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1 (A) by striking ‘‘available for a fiscal year 

2 beginning after fiscal year 2012’’ and inserting 

3 the following: ‘‘available— 

4 ‘‘(I) for fiscal year 2023’’; 

5 (B) by striking ‘‘the fiscal year involved.’’ 

6 and inserting ‘‘such fiscal year; and’’; and 

7 (C) by adding at the end the following: 

8 ‘‘(II) for fiscal year 2024 and 

9 each subsequent fiscal year, to defray 

10 the costs of the process for the review 

11 of biosimilar biological product appli12 cations (including such costs for an 

13 additional number of full-time equiva14 lent positions in the Department of 

15 Health and Human Services to be en16 gaged in such process), only if the 

17 sum of the amounts allocated by the 

18 Secretary for such costs, excluding 

19 costs paid from fees collected under 

20 this section, plus other costs for the 

21 maintenance, renovation, and repair 

22 of facilities and acquisition, mainte23 nance, and repair of fixtures, fur24 niture, and other necessary materials 

25 and supplies in connection with the 


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1 process for the review of biosimilar bi2 ological product applications, is no 

3 less than $20,000,000, multiplied by 

4 the adjustment factor applicable to 

5 the fiscal year involved.’’; and 

6 (2) in subparagraph (C), by striking ‘‘subpara7 graph (B) in any fiscal year if the costs described 

8 in such subparagraph’’ and inserting ‘‘subparagraph 

9 (B)(i) in any fiscal year if the costs allocated as de10 scribed in subclause (I) or (II) of such subpara11 graph, as applicable,’’. 

12 (c) GDUFA AUTHORITY.—Section 744B of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) 

14 is amended— 

15 (1) in subsection (e)(2), by striking 

16 ‘‘744A(11)(C)’’ and inserting ‘‘744A(12)(C)’’; and 

17 (2) in subsection (i)(2)— 

18 (A) in subparagraph (A)(ii)— 

19 (i) by striking ‘‘available for a fiscal 

20 year beginning after fiscal year 2012’’ and 

21 inserting the following: ‘‘available— 

22 ‘‘(I) for fiscal year 2023; and’’; 

23 (ii) by striking ‘‘the fiscal year in24 volved.’’ and inserting ‘‘such fiscal year; 

25 and’’; and 


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1 (iii) by adding at the end the fol2 lowing: 

3 ‘‘(II) for fiscal year 2024 and 

4 each subsequent fiscal year, to defray 

5 the costs of human generic drug ac6 tivities (including such costs for an 

7 additional number of full-time equiva8 lent positions in the Department of 

9 Health and Human Services to be en10 gaged in such activities), only if the 

11 sum of the amounts allocated by the 

12 Secretary for such costs, excluding 

13 costs paid from fees collected under 

14 this section, plus other costs for the 

15 maintenance, renovation, and repair 

16 of facilities and acquisition, mainte17 nance, and repair of fixtures, fur18 niture, and other necessary materials 

19 and supplies in connection with 

20 human generic drug activities, is no 

21 less than $97,000,000 multiplied by 

22 the adjustment factor defined in sec23 tion 744A(3) applicable to the fiscal 

24 year involved.’’; and 


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1 (B) in subparagraph (B), by striking ‘‘for 

2 human generic activities’’ and inserting ‘‘as de3 scribed in subclause (I) or (II) of such subpara4 graph, as applicable’’. 

5 (d) MDUFA AUTHORITY.—Section 738 of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is 

7 amended— 

8 (1) in subsection (h)(2)— 

9 (A) in subparagraph (A)(ii)— 

10 (i) by striking ‘‘shall be available to 

11 defray’’ and inserting the following: ‘‘shall 

12 be available— 

13 ‘‘(I) for fiscal year 2023, to de14 fray’’; 

15 (ii) by striking the period and insert16 ing ‘‘; and’’; and 

17 (iii) by adding at the end the fol18 lowing: 

19 ‘‘(II) for fiscal year 2024 and 

20 each subsequent fiscal year, to defray 

21 the costs of the resources allocated for 

22 the process for the review of device 

23 applications (including such costs for 

24 an additional number of full-time 

25 equivalent positions in the DepartVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00408 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 ment of Health and Human Services 

2 to be engaged in such process), only if 

3 the sum of the amounts allocated by 

4 the Secretary for such costs, excluding 

5 costs paid from fees collected under 

6 this section, plus other costs for the 

7 maintenance, renovation, and repair 

8 of facilities and acquisition, mainte9 nance, and repair of fixtures, fur10 niture and other necessary materials 

11 and supplies in connection with the 

12 process for the review of device appli13 cations, is no less than the amount al14 located for such costs, excluding any 

15 such costs paid from fees collected 

16 under this section, for fiscal year 

17 2009 multiplied by the adjustment 

18 factor.’’; and 

19 (B) in subparagraph (B)(i), in the matter 

20 preceding subclause (I), by striking ‘‘for the 

21 process for the review of device applications’’ 

22 and inserting ‘‘as described in subclause (I) or 

23 (II) of such subparagraph, as applicable’’; and 

24 (2) in subsection (g)(3), by striking 

25 ‘‘737(9)(C)’’ and inserting ‘‘737(10)(C)’’. 


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1 (e) TECHNICAL CORRECTION.— 

2 (1) IN GENERAL.—Section 905(b)(2) of the 

3 FDA Reauthorization Act of 2017 (Public Law 115– 

4 52) is amended by striking ‘‘Section 738(h) of the 

5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 379j(h)) is amended’’ and inserting ‘‘Subsection (g) 

7 of section 738 of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 379j), as so redesignated by 

9 section 203(f)(2)(B)(i), is amended’’. 

10 (2) EFFECTIVE DATE.—The amendment made 

11 by paragraph (1) shall take effect as though in12 cluded in the enactment of section 905 of the FDA 

13 Reauthorization Act of 2017 (Public Law 115–52). 

14 SEC. 902. ANNUAL REPORT ON INSPECTIONS. 

15 Section 902 of the FDA Reauthorization Act of 2017 

16 (Public Law 115–52) is amended, in the matter preceding 

17 paragraph (1)— 

18 (1) by striking ‘‘March 1 of each year’’ and in19 serting ‘‘120 days after the end of each fiscal year’’; 

20 and 

21 (2) by striking ‘‘previous calendar year’’ and in22 serting ‘‘previous fiscal year’’. 

23 SEC. 903. USER FEE PROGRAM TRANSPARENCY AND AC24 COUNTABILITY. 

25 (a) PDUFA.— 


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1 (1) REAUTHORIZATION; REPORTING REQUIRE2 MENTS.— 

3 (A) PERFORMANCE REPORT.—Section 

4 736B(a) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 379h–2(a)) is amended— 

6 (i) in paragraph (1)— 

7 (I) in subparagraph (B)— 

8 (aa) in clause (vii), by strik9 ing ‘‘; and’’ and inserting a semi10 colon; 

11 (bb) in clause (viii), by strik12 ing the period and inserting ‘‘; 

13 and’’; and 

14 (cc) by adding at the end 

15 the following: 

16 ‘‘(ix) the number of investigational 

17 new drug applications submitted per fiscal 

18 year, including for each review division.’’; 

19 and 

20 (II) by adding at the end the fol21 lowing flush text: 

22 ‘‘Nothing in subparagraph (B) shall be construed to 

23 authorize the disclosure of confidential commercial 

24 information or other information considered propri25 etary or trade secret, as prohibited under section 


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1 301(j) of this Act of section 1905 of title 18, United 

2 States Code.’’; and 

3 (ii) in paragraph (4)— 

4 (I) by amending subparagraph 

5 (A) to read as follows: 

6 ‘‘(A) data, analysis, and discussion of the 

7 changes in the number of individuals hired as 

8 agreed upon in the letters described in section 

9 101(b) of the Prescription Drug User Fee 

10 Amendments of 2022 and the number of re11 maining vacancies, the number of full-time 

12 equivalents funded by fees collected pursuant to 

13 section 736, and the number of full-time 

14 equivalents funded by budget authority at the 

15 Food and Drug Administration by each division 

16 within the Center for Drug Evaluation and Re17 search, the Center for Biologics Evaluation and 

18 Research, the Office of Regulatory Affairs, and 

19 the Office of the Commissioner;’’; 

20 (II) by amending subparagraph 

21 (B) to read as follows: 

22 ‘‘(B) data, analysis, and discussion of the 

23 changes in the fee revenue amounts and costs 

24 for the process for the review of human drug 

25 applications, including identifying— 


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1 ‘‘(i) drivers of such changes; and 

2 ‘‘(ii) changes in the average total cost 

3 per full-time equivalent in the prescription 

4 drug review program;’’; 

5 (III) in subparagraph (C), by 

6 striking the period and inserting ‘‘; 

7 and’’; and 

8 (IV) by adding at the end the fol9 lowing: 

10 ‘‘(D) data, analysis, and discussion of the 

11 changes in the average full-time equivalent 

12 hours required to complete review of each type 

13 of human drug application.’’. 

14 (2) REAUTHORIZATION.—Section 736B(f) of 

15 the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 379h–2(f)) is amended— 

17 (A) by redesignating paragraphs (4) 

18 through (6) as paragraphs (5) through (7), re19 spectively; 

20 (B) by inserting after paragraph (3) the 

21 following: 

22 ‘‘(4) UPDATES TO CONGRESS.—The Secretary, 

23 in consultation with regulated industry, shall provide 

24 regular updates on negotiations on the reauthoriza25 tion of this part to the Committee on Health, EduVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00413 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 cation, Labor, and Pensions of the Senate and the 

2 Committee on Energy and Commerce of the House 

3 of Representatives.’’; and 

4 (C) in paragraph (7), as so redesignated— 

5 (i) in subparagraph (A)— 

6 (I) by striking ‘‘Before pre7 senting the recommendations devel8 oped under paragraphs (1) through 

9 (5) to the Congress, the’’ and insert10 ing ‘‘The’’; and 

11 (II) by inserting ‘‘, not later than 

12 30 days after each such negotiation 

13 meeting’’ before the period at the end; 

14 and 

15 (ii) in subparagraph (B), by inserting 

16 ‘‘, in sufficient detail,’’ after ‘‘shall sum17 marize’’. 

18 (b) MDUFA.— 

19 (1) REAUTHORIZATION; REPORTING REQUIRE20 MENTS.— 

21 (A) REPORTS.—Section 738A(a)(1)(A) of 

22 the Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 379j–1(a)(1)(A)) is amended— 

24 (i) in clause (ii)— 


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1 (I) in subclause (II), by striking 

2 ‘‘; and’’ and inserting a semicolon; 

3 (II) in subclause (III), by strik4 ing the period and inserting a semi5 colon; 

6 (III) by adding at the end the 

7 following: 

8 ‘‘(IV) the number of investiga9 tional device exemption applications 

10 submitted under section 520(g) per 

11 fiscal year, including for each review 

12 division; and 

13 ‘‘(V) the number of expedited de14 velopment and priority review requests 

15 and designations under section 515B 

16 per fiscal year, including for each re17 view division.’’; and 

18 (IV) by adding at the end the fol19 lowing flush text: 

20 ‘‘Nothing in this clause shall be construed 

21 to authorize the disclosure of confidential 

22 commercial information or other informa23 tion considered proprietary or trade secret, 

24 as prohibited under section 301(j) of this 


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1 Act or section 1905 of title 18, United 

2 States Code.’’; 

3 (ii) in the first clause (iv) (relating to 

4 rationale for MDUFA program changes)— 

5 (I) by amending subclause (I) to 

6 read as follows: 

7 ‘‘(I) data, analysis, and discus8 sion of the changes in the number of 

9 individuals hired as agreed upon in 

10 the letters described in section 201(b) 

11 of the Medical Device User Fee 

12 Amendments of 2022 and the number 

13 of remaining vacancies, the number of 

14 full-time equivalents funded by fees 

15 collected pursuant to section 738, and 

16 the number of full time equivalents 

17 funded by budget authority at the 

18 Food and Drug Administration by 

19 each division within the Center for 

20 Devices and Radiological Health, the 

21 Center for Biologics Evaluation and 

22 Research, the Office of Regulatory Af23 fairs, and the Office of the Commis24 sioner;’’; 


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1 (II) by amending subclause (II) 

2 to read as follows: 

3 ‘‘(II) data, analysis, and discus4 sion of the changes in the fee revenue 

5 amounts and costs for the process for 

6 the review of device applications, in7 cluding identifying— 

8 ‘‘(aa) drivers of such 

9 changes; and 

10 ‘‘(bb) changes in the average 

11 total cost per full-time equivalent 

12 in the medical device review pro13 gram;’’; 

14 (III) in subclause (III), by strik15 ing the period and inserting ‘‘; and’’; 

16 and 

17 (IV) by adding at the end the fol18 lowing: 

19 ‘‘(IV) data, analysis, and discus20 sion of the changes in the average 

21 full-time equivalent hours required to 

22 complete review of medical device ap23 plication types.’’; and 


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1 (iii) by redesignating the second 

2 clause (iv) (relating to analysis) as clause 

3 (v). 

4 (2) REAUTHORIZATION.—Section 738A(b) of 

5 the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 379j–1(b)) is amended— 

7 (A) by redesignating paragraphs (4) 

8 through (6) as paragraphs (5) through (7), re9 spectively; 

10 (B) by inserting after paragraph (3) the 

11 following: 

12 ‘‘(4) UPDATES TO CONGRESS.—The Secretary, 

13 in consultation with regulated industry, shall provide 

14 regular updates on negotiations on the reauthoriza15 tion of this part to the Committee on Health, Edu16 cation, Labor, and Pensions of the Senate and the 

17 Committee on Energy and Commerce of the House 

18 of Representatives.’’; and 

19 (C) in paragraph (7), as so redesignated— 

20 (i) in subparagraph (A)— 

21 (I) by striking ‘‘Before pre22 senting the recommendations devel23 oped under paragraphs (1) through 

24 (5) to the Congress, the’’ and insert25 ing ‘‘The’’; and 


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1 (II) by inserting ‘‘, not later than 

2 30 days after each such negotiation 

3 meeting’’ before the period at the end; 

4 and 

5 (ii) in subparagraph (B), by inserting 

6 ‘‘, in sufficient detail,’’ after ‘‘shall sum7 marize’’. 

8 (c) GDUFA.— 

9 (1) REAUTHORIZATION; REPORTING REQUIRE10 MENTS.— 

11 (A) PERFORMANCE REPORT.—Section 

12 744C(a)(3) of the Federal Food, Drug, and 

13 Cosmetic Act (21 U.S.C. 379j–43(a)(3)) is 

14 amended— 

15 (i) by amending subparagraph (A) to 

16 read as follows: 

17 ‘‘(A) data, analysis, and discussion of the 

18 changes in the number of individuals hired as 

19 agreed upon in the letters described in section 

20 301(b) of the Generic Drug User Fee Amend21 ments of 2022 and the number of remaining va22 cancies, the number of full-time equivalents 

23 funded by fees collected pursuant to section 

24 744B, and the number of full time equivalents 

25 funded by budget authority at the Food and 


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1 Drug Administration by each division within 

2 the Center for Drug Evaluation and Research, 

3 the Center for Biologics Evaluation and Re4 search, the Office of Regulatory Affairs, and 

5 the Office of the Commissioner;’’; 

6 (ii) by amending subparagraph (B) to 

7 read as follows: 

8 ‘‘(B) data, analysis, and discussion of the 

9 changes in the fee revenue amounts and costs 

10 for human generic drug activities, including— 

11 ‘‘(i) identifying drivers of such 

12 changes; and 

13 ‘‘(ii) changes in the total average cost 

14 per full-time equivalent in the generic drug 

15 review program;’’; 

16 (iii) in subparagraph (C), by striking 

17 the period at the end and inserting ‘‘; 

18 and’’; and 

19 (iv) by adding at the end the fol20 lowing: 

21 ‘‘(D) data, analysis, and discussion of the 

22 changes in the average full-time equivalent 

23 hours required to complete review of each type 

24 of abbreviated new drug application.’’. 


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1 (2) REAUTHORIZATION.—Section 744C(f) of 

2 the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 379j–43(f)) is amended— 

4 (A) by redesignating paragraphs (4) 

5 through (6) as paragraphs (5) through (7), re6 spectively; 

7 (B) by inserting after paragraph (3) the 

8 following: 

9 ‘‘(4) UPDATES TO CONGRESS.—The Secretary, 

10 in consultation with regulated industry, shall provide 

11 regular updates on negotiations on the reauthoriza12 tion of this part to the Committee on Health, Edu13 cation, Labor, and Pensions of the Senate and the 

14 Committee on Energy and Commerce of the House 

15 of Representatives.’’; and 

16 (C) in paragraph (7), as so redesignated— 

17 (i) in subparagraph (A)— 

18 (I) by striking ‘‘Before pre19 senting the recommendations devel20 oped under paragraphs (1) through 

21 (5) to the Congress, the’’ and insert22 ing ‘‘The’’; and 

23 (II) by inserting ‘‘, not later than 

24 30 days after each such negotiation 


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1 meeting’’ before the period at the end; 

2 and 

3 (ii) in subparagraph (B), by inserting 

4 ‘‘, in sufficient detail,’’ after ‘‘shall sum5 marize’’. 

6 (d) BSUFA.— 

7 (1) REAUTHORIZATION; REPORTING REQUIRE8 MENTS.—Section 744I(a)(4) of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)(4)) 

10 is amended— 

11 (A) by amending subparagraph (A) to read 

12 as follows: 

13 ‘‘(A) data, analysis, and discussion of the 

14 changes in the number of individuals hired as 

15 agreed upon in the letters described in section 

16 401(b) of the Biosimilar User Fee Amendments 

17 of 2022 and the number of remaining vacan18 cies, the number of full-time equivalents funded 

19 by fees collected pursuant to section 744H, and 

20 the number of full time equivalents funded by 

21 budget authority at the Food and Drug Admin22 istration by each division within the Center for 

23 Drug Evaluation and Research, the Center for 

24 Biologics Evaluation and Research, the Office 


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1 of Regulatory Affairs, and the Office of the 

2 Commissioner;’’; 

3 (B) by amending subparagraph (B) to read 

4 as follows: 

5 ‘‘(B) data, analysis, and discussion of the 

6 changes in the fee revenue amounts and costs 

7 for the process for the review of biosimilar bio8 logical product applications, including identi9 fying— 

10 ‘‘(i) drivers of such changes; and 

11 ‘‘(ii) changes in the average total cost 

12 per full-time equivalent in the biosimilar 

13 biological product review program;’’; 

14 (C) in subparagraph (C), by striking the 

15 period at the end and inserting ‘‘; and’’; and 

16 (D) by adding at the end the following: 

17 ‘‘(D) data, analysis, and discussion of the 

18 changes in the average full-time equivalent 

19 hours required to complete review of each type 

20 of biosimilar biological product application.’’. 

21 (2) REAUTHORIZATION.—Section 744I(f) of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

23 379j–53(f)) is amended— 

24 (A) by redesignating paragraphs (2) and 

25 (3) as paragraphs (5) and (6), respectively; 


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1 (B) by inserting after paragraph (1) the 

2 following: 

3 ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 

4 negotiations with the regulated industry on the reau5 thorization of this part, the Secretary shall— 

6 ‘‘(A) publish a notice in the Federal Reg7 ister requesting public input on the reauthoriza8 tion; 

9 ‘‘(B) hold a public meeting at which the 

10 public may present its views on the reauthoriza11 tion; 

12 ‘‘(C) provide a period of 30 days after the 

13 public meeting to obtain written comments from 

14 the public suggesting changes to this part; and 

15 ‘‘(D) publish the comments on the Food 

16 and Drug Administration’s website. 

17 ‘‘(3) PERIODIC CONSULTATION.—Not less fre18 quently than once every month during negotiations 

19 with the regulated industry, the Secretary shall hold 

20 discussions with representatives of patient and con21 sumer advocacy groups to continue discussions of 

22 their views on the reauthorization and their sugges23 tions for changes to this part as expressed under 

24 paragraph (2). 


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1 ‘‘(4) UPDATES TO CONGRESS.—The Secretary, 

2 in consultation with regulated industry, shall provide 

3 regular updates on negotiations on the reauthoriza4 tion of this part to the Committee on Health, Edu5 cation, Labor, and Pensions of the Senate and the 

6 Committee on Energy and Commerce of the House 

7 of Representatives.’’; and 

8 (C) by adding at the end the following: 

9 ‘‘(7) MINUTES OF NEGOTIATION MEETINGS.— 

10 ‘‘(A) PUBLIC AVAILABILITY.—The Sec11 retary shall make publicly available, on the pub12 lic website of the Food and Drug Administra13 tion, minutes of all negotiation meetings con14 ducted under this subsection between the Food 

15 and Drug Administration and the regulated in16 dustry, not later than 30 days after each such 

17 negotiation meeting. 

18 ‘‘(B) CONTENT.—The minutes described 

19 under subparagraph (A) shall summarize, in 

20 sufficient detail, any substantive proposal made 

21 by any party to the negotiations as well as sig22 nificant controversies or differences of opinion 

23 during the negotiations and their resolution.’’. 


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1 SEC. 904. OTC HEARING AIDS FINAL RULE. 

2 Not later than 30 days after the date of enactment 

3 of this Act, the Secretary of Health and Human Services 

4 shall issue a final rule to establish a category of over-the5 counter hearing aids, as defined in subsection (q) of sec6 tion 520 of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 360j), as described in section 709(b) of the 

8 FDA Reauthorization Act of 2017 (Public Law 115–52). 

9 SEC. 905. ENHANCE INTRA-AGENCY COORDINATION AND 

10 PUBLIC HEALTH ASSESSMENT WITH REGARD 

11 TO COMPLIANCE ACTIVITIES. 

12 (a) COORDINATION.—Section 506D of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is 

14 amended— 

15 (1) by adding at the end the following: 

16 ‘‘(g) COORDINATION.—The Secretary shall ensure 

17 timely and effective internal coordination and alignment 

18 among the field investigators of the Food and Drug Ad19 ministration and the staff of the Center for Drug Evalua20 tion and Research’s Office of Compliance and Drug Short21 age Program regarding the reviews of reports shared pur22 suant to section 704(b)(2), and any feedback or corrective 

23 or preventive actions in response to such reports.’’; and 

24 (2) by amending subsection (f) to read as fol25 lows: 


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1 ‘‘(f) TEMPORARY SUNSET.—Subsection (a) shall 

2 cease to be effective on the date that is 5 years after the 

3 date of enactment of the Food and Drug Administration 

4 Safety and Innovation Act. Subsections (b), (c), and (e) 

5 shall not be in effect during the period beginning 5 years 

6 after the date of enactment of the Food and Drug Admin7 istration Safety and Innovation Act and ending on the 

8 date of enactment of the Food and Drug Administration 

9 Safety and Landmark Advancements Act of 2022. Sub10 sections (b), (c), and (e) shall be in effect beginning on 

11 the date of enactment of the Food and Drug Administra12 tion Safety and Landmark Advancements Act of 2022.’’. 

13 (b) REPORTING.—Section 506C–1(a) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 356c–1(a)) is 

15 amended— 

16 (1) by redesignating paragraphs (3) through 

17 (7) as paragraphs (4) through (8), respectively; 

18 (2) by inserting after paragraph (2) the fol19 lowing: 

20 ‘‘(3) provides the number of reports that were 

21 required under section 704(b)(2) to be sent to the 

22 appropriate offices of the Food and Drug Adminis23 tration with expertise regarding drug shortages, and 

24 the number of such reports that were sent;’’; and 


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1 (3) in paragraph (3)(A), by striking ‘‘paragraph 

2 (7)’’ and inserting ‘‘paragraph (8)’’. 

3 (c) APPLICABILITY.— 

4 (1) SUBSECTION (a).—The amendments made 

5 by subsection (a) shall apply beginning on the date 

6 of enactment of this Act. 

7 (2) SUBSECTION (b).—The amendments made 

8 by subsection (b) shall apply beginning on the date 

9 that is 1 year after the date of enactment of this 

10 Act. 

11 (d) REPORTING OF MUTUAL RECOGNITION AGREE12 MENTS FOR INSPECTIONS AND REVIEW ACTIVITIES.— 

13 Section 510(h) of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 360(h)) is amended— 

15 (1) in paragraph (6)— 

16 (A) in subparagraph (A), by striking 

17 clause (ii) and inserting the following: 

18 ‘‘(ii) the number of such registered estab19 lishments in each region of interest; 

20 ‘‘(iii) the number of such domestic estab21 lishments and the number of such foreign es22 tablishments, including the number of establish23 ments in each region of interest, that the Sec24 retary inspected in the previous calendar year; 


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1 ‘‘(iv) the number of inspections to support 

2 actions by the Secretary on applications under 

3 section 505 of this Act or section 351 of the 

4 Public Health Service Act, including the num5 ber of inspections to support actions by the Sec6 retary on supplemental applications, including 

7 changes to manufacturing processes, the Sec8 retary conducted in the previous fiscal year; 

9 ‘‘(v) the number of routine surveillance in10 spections the Secretary conducted in the pre11 vious fiscal year; 

12 ‘‘(vi) the number of for-cause inspections 

13 the Secretary conducted in the previous fiscal 

14 year, not including inspections described in 

15 clause (iv); and 

16 ‘‘(vii) the number of inspections the Sec17 retary has recognized pursuant to an agreement 

18 entered into pursuant to section 809, or other19 wise recognized, for each of the types of inspec20 tions described in clauses (v) and (vi);’’; 

21 (B) in subparagraph (B), by striking ‘‘; 

22 and’’ and inserting a semicolon; 

23 (C) in subparagraph (C), by striking the 

24 period and inserting ‘‘; and’’; and 

25 (D) by adding at the end the following: 


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1 ‘‘(D) the status of the efforts of the Food 

2 and Drug Administration to expand its recogni3 tion of inspections conducted or recognized by 

4 foreign regulatory authorities under section 

5 809, including any obstacles to expanding the 

6 use of such recognition.’’; and 

7 (2) by adding at the end the following: 

8 ‘‘(7) REGION OF INTEREST.—For purposes of 

9 paragraph (6)(A), the term ‘region of interest’ 

10 means a foreign geographic region or country, in11 cluding the People’s Republic of China, India, the 

12 European Union, the United Kingdom, and any 

13 other country or geographic region, as the Secretary 

14 determines appropriate.’’. 

15 (e) ENHANCING TRANSPARENCY OF DRUG FACILITY

16 INSPECTION TIMELINES.—Section 902 of the FDA Reau17 thorization Act of 2017 (21 U.S.C. 355 note) is amended 

18 to read as follows: 

19 ‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 

20 ‘‘Not later than March 1 of each year, the Secretary 

21 of Health and Human Services shall post on the website 

22 of the Food and Drug Administration information related 

23 to inspections of facilities necessary for approval of a drug 

24 under subsection (c) or (j) of section 505 of the Federal 

25 Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval 


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1 of a device under section 515 of such Act (21 U.S.C. 

2 360e), or clearance of a device under section 510(k) of 

3 such Act (21 U.S.C. 360(k)) that were conducted during 

4 the previous calendar year. Such information shall include 

5 the following: 

6 ‘‘(1) The median time following a request from 

7 staff of the Food and Drug Administration review8 ing an application or report to the beginning of the 

9 inspection, including— 

10 ‘‘(A) the median time for drugs described 

11 in 505(j)(11)(A)(i) of the Federal Food, Drug, 

12 and Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i)); 

13 ‘‘(B) the median time for drugs described 

14 in section 506C(a) of such Act (21 U.S.C. 

15 356c(a)) only; and 

16 ‘‘(C) the median time for drugs on the 

17 drug shortage list in effect under section 506E 

18 of such Act (21 U.S.C. 356f). 

19 ‘‘(2) The median time from the issuance of a 

20 report pursuant to section 704(b) of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) 

22 to the sending of a warning letter, issuance of an 

23 import alert, or holding of a regulatory meeting for 

24 inspections for which the Secretary concluded that 

25 regulatory or enforcement action was indicated, inVerDate Sep 11 2014 21:28 May 31, 2022 Jkt 029200 PO 00000 Frm 00431 Fmt 6652 Sfmt 6201 E:\BILLS\S4348.IS S4348

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1 cluding the median time for each category of drugs 

2 listed in subparagraphs (A) through (C) of para3 graph (1). 

4 ‘‘(3) The median time from the sending of a 

5 warning letter, issuance of an import alert, or hold6 ing of a regulatory meeting related to conditions ob7 served by the Secretary during an inspection, to the 

8 time at which the Secretary concludes that corrective 

9 actions to resolve such conditions have been taken. 

10 ‘‘(4) The median time spent by staff of the 

11 Food and Drug Administration at a facility during 

12 an inspection, including— 

13 ‘‘(A) the median time when records were 

14 provided remotely in accordance with a request 

15 under section 704(a)(4) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) 

17 in advance of the inspection; and 

18 ‘‘(B) the median time when a request for 

19 records pursuant to such section 704(a)(4) was 

20 not issued, or complied with, in advance of the 

21 inspection. 

22 ‘‘(5) The number and type of violations identi23 fied during inspections when a request for records 

24 pursuant to such section 704(a)(4) was issued and 

25 complied with in advance of the inspection, versus 


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1 when a request for records pursuant to such section 

2 704(a)(4) was not issued or complied with. 

3 ‘‘(6) The number of facilities that did not im4 plement requested corrective or preventive actions 

5 following a report issued pursuant to such section 

6 704(b), resulting in a withhold recommendation, in7 cluding the number of such times for each category 

8 of drugs listed in subparagraphs (A) through (C) of 

9 paragraph (1).’’. 

Æ 


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