I 

118TH CONGRESS 

1ST SESSION H. R. 2369 

To amend the Federal Food, Drug, and Cosmetic Act with respect to in 

vitro clinical tests, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 29, 2023 

Mr. BUCSHON (for himself and Ms. DEGETTE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

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

respect to in vitro clinical tests, 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. 

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

5 ‘‘Verifying Accurate Leading-edge IVCT Development Act 

6 of 2023’’ or the ‘‘VALID Act of 2023’’. 

7 SEC. 2. DEFINITIONS. 

8 (a) IN GENERAL.—Section 201 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 321) is amended— 


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1 (1) by adding at the end the following: 

2 ‘‘(ss)(1) The term ‘in vitro clinical test’ means an ar3 ticle specified in subparagraph (2) that is intended to be 

4 used in the collection, preparation, analysis, or in vitro 

5 clinical examination of specimens taken or derived from 

6 the human body for the purpose of— 

7 ‘‘(A) identifying or diagnosing a disease or con8 dition; 

9 ‘‘(B) providing information for diagnosing, 

10 screening, measuring, detecting, predicting, 

11 prognosing, analyzing, or monitoring a disease or 

12 condition, including by making a determination of 

13 an individual’s state of health; or 

14 ‘‘(C) selecting, monitoring, or informing ther15 apy or treatment for a disease or condition. 

16 ‘‘(2) An article specified in this subparagraph is— 

17 ‘‘(A) a test kit; 

18 ‘‘(B) a test system; 

19 ‘‘(C) a test protocol or laboratory test protocol; 

20 ‘‘(D) an instrument (as defined in section 

21 587(11)); 

22 ‘‘(E) a specimen receptacle (as defined in sec23 tion 587(17)); 


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1 ‘‘(F) software, excluding software that is ex2 cluded by section 520(o) from the definition of a de3 vice under section 201(h), that— 

4 ‘‘(i) is a component or part of another in 

5 vitro clinical test or analyzes, processes, or in6 terprets a signal or pattern from another in 

7 vitro clinical test; and 

8 ‘‘(ii) does not analyze, process, or interpret 

9 a signal, pattern, or medical image from a de10 vice; and 

11 ‘‘(G) subject to subparagraph (3), a component 

12 or part of a test kit, a test system, a test protocol 

13 or laboratory test protocol, an instrument, a speci14 men receptacle, or software described in subpara15 graph (F), whether alone or in combination, includ16 ing reagents, calibrators, and controls. 

17 ‘‘(3) Notwithstanding subparagraph (2)(G), an arti18 cle intended to be used as a component or part of an in 

19 vitro clinical test described in subparagraph (1) is ex20 cluded from the definition in subparagraph (1) if the arti21 cle consists of any of the following: 

22 ‘‘(A) Blood, blood components, or human cells 

23 or tissues, from the time of acquisition, donation, or 

24 recovery of such article, including determination of 

25 donor eligibility, as applicable, until such time as the 


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1 article is released as a component or part of an in 

2 vitro clinical test by the establishment that collected 

3 such article. 

4 ‘‘(B) An article used for invasive sampling, a 

5 needle, or a lancet, except to the extent such article, 

6 needle, or lancet is an integral component of an arti7 cle for holding, storing, or transporting a specimen. 

8 ‘‘(C) General purpose laboratory equipment.’’; 

9 (2) by adding at the end of paragraph (g) the 

10 following: 

11 ‘‘(3) The term ‘drug’ does not include an in vitro clin12 ical test.’’; and 

13 (3) in paragraph (h)(1), in the matter following 

14 clause (C), by striking ‘‘section 520(o)’’ and insert15 ing ‘‘section 520(o) or an in vitro clinical test’’. 

16 (b) EXCLUSION FROM DEFINITION OF BIOLOGICAL

17 PRODUCT.—Section 351(i)(1) of the Public Health Serv18 ice Act (42 U.S.C. 262(i)(1)) is amended— 

19 (1) by striking ‘‘(1) The term ‘biological prod20 uct’ means’’ and inserting ‘‘(1)(A) The term ‘biologi21 cal product’ means’’; and 

22 (2) by adding at the end the following: 

23 ‘‘(B) The term ‘biological product’ does not in24 clude an in vitro clinical test as defined in section 


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1 201(ss) of the Federal Food, Drug, and Cosmetic 

2 Act.’’. 

3 (c) IN VITRO CLINICAL TEST DEFINITION.—In this 

4 Act, the term ‘‘in vitro clinical test’’ has the meaning given 

5 such term in section 201(ss) of the Federal Food, Drug, 

6 and Cosmetic Act, as added by subsection (a). 

7 SEC. 3. REGULATION OF IN VITRO CLINICAL TESTS. 

8 The Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 301 et seq.) is amended— 

10 (1) by amending the heading of chapter V to 

11 read as follows: ‘‘DRUGS, DEVICES, AND IN 

12 VITRO CLINICAL TESTS’’; and 

13 (2) by adding at the end of chapter V the fol14 lowing: 

15 ‘‘Subchapter J—In Vitro Clinical Tests 

16 ‘‘SEC. 587. DEFINITIONS. 

17 ‘‘In this subchapter: 

18 ‘‘(1) ANALYTICAL VALIDITY.—The term ‘ana19 lytical validity’ means, with respect to an in vitro 

20 clinical test, the ability of the in vitro clinical test, 

21 to identify, measure, detect, calculate, or analyze (or 

22 assist in such identification, measurement, detection, 

23 calculation, or analysis of) one or more analytes, bio24 markers, substances, or other targets intended to be 


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1 identified, measured, detected, calculated, or ana2 lyzed by the test. 

3 ‘‘(2) APPLICABLE STANDARD.—The term ‘ap4 plicable standard’, with respect to an in vitro clinical 

5 test, means a reasonable assurance of analytical and 

6 clinical validity for its indications for use, and a rea7 sonable assurance of safety for individuals who come 

8 into contact with such in vitro clinical test, except 

9 that such term, with respect to specimen receptacles 

10 and test instruments, means a reasonable assurance 

11 of analytical validity for its indications for use and 

12 safety for individuals who come into contact with 

13 such specimen receptacle or test instrument. 

14 ‘‘(3) CLINICAL USE.—The term ‘clinical use’ 

15 means the operation, application, or functioning of 

16 an in vitro clinical test for the purpose for which it 

17 is intended as described in section 201(ss)(1). 

18 ‘‘(4) CLINICAL VALIDITY.—The term ‘clinical 

19 validity’ means the ability of an in vitro clinical test 

20 to achieve the purpose for which it is intended as de21 scribed in section 201(ss)(1). 

22 ‘‘(5) COMPONENT OR PART.—The term ‘compo23 nent or part’ means a substance, piece, part, raw 

24 material, software, firmware, labeling, or assembly, 

25 including reagents, that is intended to be included as 


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1 an aspect of an in vitro clinical test described in sec2 tion 201(ss)(1). 

3 ‘‘(6) DEVELOP.—The term ‘develop’, with re4 spect to an in vitro clinical test, means— 

5 ‘‘(A) designing, validating, producing, 

6 manufacturing, remanufacturing, labeling, ad7 vertising, propagating, importing, or assembling 

8 an in vitro clinical test; 

9 ‘‘(B) modifying an in vitro clinical test, in10 cluding modifying the indications for use of the 

11 in vitro clinical test, or modifying an article to 

12 be an in vitro clinical test; or 

13 ‘‘(C) establishing a test system as de14 scribed or included in a test protocol developed 

15 by another entity unless such test protocol is 

16 listed as an in vitro clinical test in the com17 prehensive test information system established 

18 under section 587T by that other entity. 

19 ‘‘(7) DEVELOPER.—The term ‘developer’ means 

20 a person who engages in development as described in 

21 paragraph (6), except the term does not include a 

22 laboratory that— 

23 ‘‘(A) is certified by the Secretary under 

24 section 353 of the Public Health Service Act; 

25 and 


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1 ‘‘(B) assembles for use solely within that 

2 laboratory, without otherwise developing, an in 

3 vitro clinical test appropriately listed in the 

4 comprehensive test information system estab5 lished under section 587T by a different person. 

6 ‘‘(8) FIRST-OF-A-KIND.—The term ‘first-of-a7 kind’, with respect to an in vitro clinical test, means 

8 that such test has any novel combination of the ele9 ments specified in paragraph (10) that differs from 

10 in vitro clinical tests that already are legally avail11 able in the United States, except for such tests of12 fered under section 587C(a)(3), 587C(a)(4), or 

13 587G. 

14 ‘‘(9) HIGH-RISK.—The term ‘high-risk’, with 

15 respect to an in vitro clinical test or category of in 

16 vitro clinical tests, means that an undetected inac17 curate result from such test, or such category of 

18 tests, when used as intended— 

19 ‘‘(A)(i) is reasonably likely to result in se20 rious or irreversible harm or death to a patient 

21 or patients, or would otherwise cause serious 

22 harm to the public health; or 

23 ‘‘(ii) is reasonably likely to result in the 

24 absence, significant delay, or discontinuation of 


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1 life-supporting or life-sustaining medical treat2 ment; and 

3 ‘‘(B) mitigating measures are not able to 

4 be established and applied to prevent, mitigate, 

5 or detect the inaccurate result, or otherwise suf6 ficiently mitigate the risk resulting from an un7 detected inaccurate result described in subpara8 graph (A), such that the test would be mod9 erate-risk or low-risk. 

10 ‘‘(10) INDICATIONS FOR USE.—The term ‘indi11 cations for use’, with respect to an in vitro clinical 

12 test, means the following elements: 

13 ‘‘(A) Substance or substances measured by 

14 the in vitro clinical test, such as an analyte, 

15 protein, or pathogen. 

16 ‘‘(B) Test method. 

17 ‘‘(C) Test purpose or purposes, as de18 scribed in section 201(ss)(1). 

19 ‘‘(D) Diseases or conditions for which the 

20 in vitro clinical test is intended for use, includ21 ing intended patient populations. 

22 ‘‘(E) Context of use, such as in a clinical 

23 laboratory, in a health care facility, prescription 

24 home use, over-the-counter use, or direct-to25 consumer testing. 


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1 ‘‘(11) INSTRUMENT.— 

2 ‘‘(A) IN GENERAL.—The term ‘instrument’ 

3 means an analytical or pre-analytical instru4 ment. 

5 ‘‘(B) ANALYTIC INSTRUMENT.—The term 

6 ‘analytic instrument’ means an in vitro clinical 

7 test that is hardware intended by the developer 

8 to be used with one or more other in vitro clin9 ical tests to generate a clinical test result, in10 cluding software used to effectuate the 

11 functionality of the hardware. 

12 ‘‘(C) PRE-ANALYTICAL INSTRUMENT.—The 

13 term ‘pre-analytical instrument’ means an in 

14 vitro clinical test that is hardware intended by 

15 the developer solely to generate an output for 

16 use exclusively with one or more analytical in17 struments as defined in subparagraph (B) and 

18 which does not itself generate a clinical test re19 sult. Such term may include software used to 

20 effectuate the hardware’s functionality. 

21 ‘‘(12) INSTRUMENT FAMILY.—The term ‘instru22 ment family’ means more than one instrument devel23 oped by the same developer for which the developer 

24 demonstrates and documents, with respect to all 

25 such instruments, that all— 


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1 ‘‘(A) have the same basic architecture, de2 sign, and performance characteristics; 

3 ‘‘(B) have the same indications for use and 

4 capabilities; 

5 ‘‘(C) share the same measurement prin6 ciples, detection methods, and reaction condi7 tions, as applicable; and 

8 ‘‘(D) produce the same or similar analyt9 ical results from samples of the same specimen 

10 type or types. 

11 ‘‘(13) LABORATORY OPERATIONS.—The term 

12 ‘laboratory operations’— 

13 ‘‘(A) means the conduct of a laboratory ex14 amination or other laboratory procedure on ma15 terials derived from the human body, including 

16 the conduct of an in vitro clinical test and asso17 ciated activities, that is— 

18 ‘‘(i) regulated under section 353 of 

19 the Public Health Service Act; and 

20 ‘‘(ii) not related to the design, analyt21 ical validation, or clinical validation of an 

22 in vitro clinical test; and 

23 ‘‘(B) includes— 


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1 ‘‘(i) performing pre-analytical and 

2 post-analytical processes for an in vitro 

3 clinical test; 

4 ‘‘(ii) standard operating procedures 

5 and the conduct thereof; and 

6 ‘‘(iii) preparing reagents or other test 

7 materials that do not meet the criteria for 

8 being an in vitro clinical test for clinical 

9 use. 

10 ‘‘(14) LOW-RISK.—The term ‘low-risk’, with re11 spect to an in vitro clinical test or category of in 

12 vitro clinical tests, means that an undetected inac13 curate result from such in vitro clinical test, or such 

14 category of in vitro clinical tests, when used as in15 tended— 

16 ‘‘(A) would cause only minimal or imme17 diately reversible harm, and would lead to only 

18 a remote risk of adverse patient impact or ad19 verse public health impact; or 

20 ‘‘(B) sufficient mitigating measures are 

21 able to be established and applied such that the 

22 in vitro clinical test meets the standard de23 scribed in subparagraph (A). 

24 ‘‘(15) MITIGATING MEASURES.—The term 

25 ‘mitigating measures’— 


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1 ‘‘(A) means controls, standards, and other 

2 requirements that the Secretary determines, 

3 based on evidence, are necessary— 

4 ‘‘(i) for an in vitro clinical test, or a 

5 category of in vitro clinical tests, to meet 

6 the applicable standard; or 

7 ‘‘(ii) to mitigate the risk of harm en8 suing from an undetected inaccurate result 

9 or misinterpretation of a result; and 

10 ‘‘(B) may include, as required by the Sec11 retary, as appropriate, applicable requirements 

12 regarding labeling, conformance to performance 

13 standards and consensus standards, perform14 ance testing, submission of clinical data, adver15 tising, website posting of information, clinical 

16 studies, postmarket surveillance, user com17 prehension studies, training, and confirmatory 

18 laboratory, clinical findings, the history of the 

19 developer, the role of a health professional in 

20 the testing process, such as integration of the 

21 testing laboratory into the direct medical care 

22 of the patient, including direct interaction be23 tween the testing laboratory and treating physi24 cian, or testing. 


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1 ‘‘(16) MODERATE-RISK.—The term ‘moderate2 risk’, with respect to an in vitro clinical test or cat3 egory of in vitro clinical tests— 

4 ‘‘(A) means a test or category of tests that 

5 is not high-risk under the criteria under para6 graph (9) or low-risk under the criteria under 

7 paragraph (14); and 

8 ‘‘(B) may include a test or category of 

9 tests that, when used as intended, meet the cri10 teria specified in paragraph (9)(A) for high11 risk, but for which one or more mitigating 

12 measures are able to be established and applied 

13 to prevent, mitigate, or detect an inaccurate re14 sult or otherwise sufficiently mitigate the risk 

15 resulting from an undetected inaccurate result, 

16 but are not sufficient such that the test is low17 risk under the criteria in paragraph (14). 

18 ‘‘(17) SPECIMEN RECEPTACLE.—The term 

19 ‘specimen receptacle’ means an in vitro clinical test 

20 intended for taking, collecting, holding, storing, or 

21 transporting of specimens derived from the human 

22 body or for preparation, analysis, or in vitro clinical 

23 examination for purposes described in section 

24 201(ss)(1). 

25 ‘‘(18) TECHNOLOGY.—The term ‘technology’— 


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1 ‘‘(A) means a set of control mechanisms, 

2 energy sources, or operating principles— 

3 ‘‘(i) that do not differ significantly 

4 among multiple in vitro clinical tests; and 

5 ‘‘(ii) for which design and develop6 ment (including analytical and clinical vali7 dation, as applicable) of the tests would be 

8 addressed in a similar manner or through 

9 similar procedures; and 

10 ‘‘(B) may include clot detection, colori11 metric (non-immunoassay), electrochemical 

12 (non-immunoassay), enzymatic (non13 immunoassay), flow cytometry, fluorometry 

14 (non-immunoassay), immunoassay, mass spec15 trometry or chromatography, microbial culture, 

16 next generation sequencing, nephlometric or 

17 turbidimetric (non-immunoassay), singleplex or 

18 multiplex non-NGS nucleic acid analysis, slide19 based technology, spectroscopy, and any other 

20 technology, as the Secretary determines appro21 priate. 

22 ‘‘(19) TEST.—The term ‘test’, unless otherwise 

23 provided, means an in vitro clinical test. 

24 ‘‘(20) VALID SCIENTIFIC EVIDENCE.—The term 

25 ‘valid scientific evidence’— 


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1 ‘‘(A) means, with respect to an in vitro 

2 clinical test, evidence that— 

3 ‘‘(i) has been generated and evaluated 

4 by persons qualified by training or experi5 ence to do so, using procedures generally 

6 accepted by other persons so qualified; and 

7 ‘‘(ii) forms an appropriate basis for 

8 concluding by qualified experts whether the 

9 applicable standard has been met by the in 

10 vitro clinical test; and 

11 ‘‘(B) may include evidence described in 

12 subparagraph (A) consisting of— 

13 ‘‘(i) peer-reviewed literature; 

14 ‘‘(ii) clinical guidelines; 

15 ‘‘(iii) reports of significant human ex16 perience with an in vitro clinical test; 

17 ‘‘(iv) bench studies; 

18 ‘‘(v) case studies or histories; 

19 ‘‘(vi) clinical data; 

20 ‘‘(vii) consensus standards; 

21 ‘‘(viii) reference standards; 

22 ‘‘(ix) data registries; 

23 ‘‘(x) postmarket data; 

24 ‘‘(xi) real world data; 

25 ‘‘(xii) clinical trials; and 


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1 ‘‘(xiii) data collected in countries 

2 other than the United States if such data 

3 are demonstrated to be appropriate for the 

4 purpose of making a regulatory determina5 tion under this subchapter. 

6 ‘‘SEC. 587A. REGULATION OF IN VITRO CLINICAL TESTS. 

7 ‘‘(a) IN GENERAL.—No person shall introduce or de8 liver for introduction into interstate commerce any in vitro 

9 clinical test, unless— 

10 ‘‘(1) an approval of an application filed pursu11 ant to subsection (a) or (b) of section 587B is effec12 tive with respect to such in vitro clinical test; 

13 ‘‘(2) the in vitro clinical test is offered under a 

14 technology certification order under section 

15 587D(b)(1); or 

16 ‘‘(3) the test is exempt under sections 587C or 

17 587G from the requirements of section 587B. 

18 ‘‘(b) TRANSFER OR SALE OF IN VITRO CLINICAL

19 TESTS.— 

20 ‘‘(1) TRANSFER AND ASSUMPTION OF REGU21 LATORY OBLIGATIONS.—If ownership of an in vitro 

22 clinical test is sold or transferred in such manner 

23 that the developer transfers the regulatory submis24 sions and obligations applicable under this sub25 chapter with respect to the test, the transferee or 


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1 purchaser becomes the developer of the test and 

2 shall have all regulatory obligations applicable to 

3 such a test under this subchapter. The transferee or 

4 purchaser shall update the registration and listing 

5 information under section 587J for the in vitro clin6 ical test. 

7 ‘‘(2) TRANSFER OR SALE OF PREMARKET AP8 PROVAL.— 

9 ‘‘(A) NOTICE REQUIRED.—If a developer 

10 of an in vitro clinical test transfers or sells the 

11 approval of the in vitro clinical test, the trans12 feror or seller shall— 

13 ‘‘(i) submit a notice of the transfer or 

14 sale to the Secretary and update the reg15 istration and listing information under sec16 tion 587J for the in vitro clinical test; and 

17 ‘‘(ii) submit a supplement to an appli18 cation if required under section 587B(h). 

19 ‘‘(B) EFFECTIVE DATE OF APPROVAL

20 TRANSFER.—A transfer or sale described in 

21 subparagraph (A) shall become effective upon 

22 completion of a transfer or sale described in 

23 paragraph (1) or the approval of a supplement 

24 to an application under section 587B(h) if re25 quired, whichever is later. The transferee or 


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1 purchaser shall update the registration and list2 ing information under section 587J for the in 

3 vitro clinical test within 15 calendar days of the 

4 effective date of the transfer or sale. 

5 ‘‘(3) TRANSFER OR SALE OF TECHNOLOGY CER6 TIFICATION.— 

7 ‘‘(A) REQUIREMENTS FOR TRANSFER OR

8 SALE OF TECHNOLOGY CERTIFICATION.—An 

9 unexpired technology certification can be trans10 ferred or sold if the transferee or purchaser— 

11 ‘‘(i) is an eligible person under section 

12 587D(a)(2); and 

13 ‘‘(ii) maintains, upon such transfer or 

14 sale, test design and quality requirements, 

15 processes and procedures under the scope 

16 of technology certification, and scope of the 

17 technology certification identified in the 

18 applicable technology certification order. 

19 ‘‘(B) NOTICE REQUIRED.—If a developer 

20 of an in vitro clinical test transfers or sells a 

21 technology certification order that has not ex22 pired, the transferor or seller shall submit a no23 tice of the transfer or sale to the Secretary and 

24 shall update the registration and listing infor25 mation under section 587J for all in vitro clinVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 ical tests covered by the technology certifi2 cation. 

3 ‘‘(C) EFFECTIVE DATE OF TECHNOLOGY

4 CERTIFICATION TRANSFER.—The transfer of a 

5 technology certification shall become effective 

6 upon completion of a transfer or sale described 

7 in subparagraph (A). The transferee or pur8 chaser shall update the registration and listing 

9 information under section 587J for the in vitro 

10 clinical test within 30 calendar days of the ef11 fective date of the technology certification 

12 transfer. 

13 ‘‘(D) NEW TECHNOLOGY CERTIFICATION

14 REQUIRED.—If the requirements of subpara15 graph (A)(ii) are not met, the technology cer16 tification order may not be transferred and the 

17 transferee or purchaser of an in vitro clinical 

18 test is required to submit an application for 

19 technology certification and obtain a technology 

20 certification order prior to offering the test for 

21 clinical use. 

22 ‘‘(c) REGULATIONS.—The Secretary may issue regu23 lations to implement this subchapter. 

24 ‘‘SEC. 587B. PREMARKET REVIEW. 

25 ‘‘(a) APPLICATION.— 


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1 ‘‘(1) FILING.—Any developer may file with the 

2 Secretary an application for premarket approval of 

3 an in vitro clinical test under this subsection. 

4 ‘‘(2) TRANSPARENCY AND PREDICTABILITY.—If 

5 a developer files a premarket application under this 

6 section and provides any additional documentation 

7 required under section 587D, the in vitro clinical 

8 test that is the subject of the premarket application 

9 may be utilized as the representative in vitro clinical 

10 test reviewed by the Secretary to support a tech11 nology certification order under section 587D. 

12 ‘‘(3) APPLICATION CONTENT.—An application 

13 submitted under paragraph (1) shall include the fol14 lowing, in such format as the Secretary specifies: 

15 ‘‘(A) General information regarding the in 

16 vitro clinical test, including— 

17 ‘‘(i) the name and address of the ap18 plicant; 

19 ‘‘(ii) the table of contents for the ap20 plication and the identification of the infor21 mation the applicant claims as trade secret 

22 or confidential commercial or financial in23 formation; 


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1 ‘‘(iii) a description of the test’s design 

2 and intended use, including the indications 

3 for use; and 

4 ‘‘(iv) a description regarding test 

5 function and performance characteristics. 

6 ‘‘(B) A summary of the data and informa7 tion in the application for the in vitro clinical 

8 test, including— 

9 ‘‘(i) a brief description of the foreign 

10 and domestic marketing history of the test, 

11 if any, including a list of all countries in 

12 which the test has been marketed and a 

13 list of all countries in which the test has 

14 been withdrawn from the market for any 

15 reason related to the ability of the in vitro 

16 clinical test to meet the applicable stand17 ard, if known by the applicant; 

18 ‘‘(ii) a description of benefit and risk 

19 considerations related to the in vitro clin20 ical test, including a description of any ap21 plicable adverse effects of the test on 

22 health and how such adverse effects have 

23 been, or will be, mitigated; 

24 ‘‘(iii) a risk assessment of the test; 

25 and 


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1 ‘‘(iv) a description of how the data 

2 and information in the application con3 stitute valid scientific evidence and support 

4 a showing that the test meets the applica5 ble standard under section 587(2). 

6 ‘‘(C) The signature of the developer filing 

7 the premarket application or an authorized rep8 resentative. 

9 ‘‘(D) A bibliography of applicable pub10 lished reports and a description of any studies 

11 conducted, including any unpublished studies 

12 related to such test, that are known or that 

13 should reasonably be known to the applicant, 

14 and a description of data and information rel15 evant to the evaluation of whether the test 

16 meets the applicable standard. 

17 ‘‘(E) Applicable information regarding the 

18 methods used in, and the facilities or controls 

19 used for, the development of the test to dem20 onstrate compliance with the applicable quality 

21 requirements under section 587K. 

22 ‘‘(F) Information demonstrating compli23 ance with any relevant and applicable— 

24 ‘‘(i) mitigating measures under sec25 tion 587E; and 


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1 ‘‘(ii) standards established or recog2 nized under section 514 prior to the date 

3 of enactment of the VALID Act of 2023, 

4 or, after applicable standards are estab5 lished or recognized under section 587R, 

6 with such standards. 

7 ‘‘(G) Valid scientific evidence to support 

8 that the test meets the applicable standard, 

9 which shall include— 

10 ‘‘(i) summary information for all sup11 porting validation studies performed, in12 cluding a description of the objective of the 

13 study, a description of the experimental de14 sign of the study, a description of any limi15 tations of the study, a brief description of 

16 how the data were collected and analyzed, 

17 a brief description of the results of each 

18 study, and conclusions drawn from each 

19 study; 

20 ‘‘(ii) raw data for each study, which 

21 may include, as applicable, tabulations of 

22 data and results; and 

23 ‘‘(iii) for nonclinical laboratory studies 

24 involving the test, if applicable, a state25 ment that studies were conducted in comVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 pliance with applicable good laboratory 

2 practices. 

3 ‘‘(H) To the extent the application seeks 

4 authorization to make modifications to the test 

5 within the scope of the approval that are not 

6 otherwise permitted without premarket review 

7 under this subchapter, a proposed change pro8 tocol that includes validation procedures and 

9 acceptance criteria for anticipated modifications 

10 that could be made to the test within the scope 

11 of the approval. 

12 ‘‘(I) Proposed labeling, in accordance with 

13 the requirements of section 587L. 

14 ‘‘(J) Such other data or information as the 

15 Secretary may require in accordance with the 

16 least burdensome requirements under section 

17 587AA(c). 

18 ‘‘(4) REGULATION FOR PREMARKET AND AB19 BREVIATED PREMARKET APPLICATIONS.—Not later 

20 than 3 years after the date of enactment of the 

21 VALID Act of 2023, the Secretary shall promulgate 

22 final regulations detailing the information to be pro23 vided in a premarket application and abbreviated 

24 premarket application under this section. 


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1 ‘‘(5) REFUSE TO FILE A PREMARKET OR AB2 BREVIATED PREMARKET APPLICATION.—The Sec3 retary may refuse to file an application under this 

4 section only for lack of completeness or legibility of 

5 the application. If, after receipt of an application 

6 under this section, the Secretary refuses to file such 

7 an application, the Secretary shall provide to the de8 veloper, within 45 calendar days of receipt of such 

9 application submitted under this subsection or with10 in 30 calendar days of receipt of an application sub11 mitted under subsection (b), a description of the rea12 son for such refusal, and identify the information re13 quired, if any, to allow for the filing of the applica14 tion. 

15 ‘‘(6) SUBSTANTIVE REVIEW FOR DEFICIENT AP16 PLICATION.—If, after receipt of an application under 

17 this section, the Secretary determines that any por18 tion of such application is materially deficient, the 

19 Secretary shall provide to the applicant a description 

20 of such material deficiencies and the information re21 quired to resolve such deficiencies. 

22 ‘‘(7) INSPECTIONS.—With respect to an appli23 cation under paragraph (1), preapproval inspections 

24 authorized by an employee of the Food and Drug 

25 Administration or a person accredited under section 


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•HR 2369 IH

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)(3), except 

19 that applications under paragraph (1) need not 

20 include— 

21 ‘‘(i) quality requirement information; 

22 or 

23 ‘‘(ii) raw data, unless requested in 

24 writing by the Secretary, in accordance 

25 with the least burdensome requirements 


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•HR 2369 IH

1 under section 587AA(c), and with super2 visory review and concurrence prior to 

3 issuance of such request; and 

4 ‘‘(B) data, as applicable, to support soft5 ware validation, electromagnetic compatibility, 

6 and electrical safety, and information dem7 onstrating compliance with maintaining quality 

8 systems documentation. 

9 ‘‘(3) SAFETY INFORMATION.—The developer of 

10 an in vitro clinical test specimen receptacle reviewed 

11 under this subsection shall maintain safety informa12 tion for such specimen receptacle. 

13 ‘‘(4) INSPECTIONS.—With respect to an appli14 cation under paragraph (1), preapproval inspections 

15 shall not be required unless requested in writing by 

16 the Secretary, after supervisory review and concur17 rence, because such inspection is considered nec18 essary to complete the review. 

19 ‘‘(c) INSTRUMENTS AND INSTRUMENT FAMILIES.— 

20 ‘‘(1) IN GENERAL.—A developer of an instru21 ment family shall file with the Secretary an applica22 tion for premarket approval of one version of an in23 strument under this subsection. Any modified 

24 versions of the instrument that generate a new in25 strument within the same instrument family shall be 


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•HR 2369 IH

1 exempt from premarket review requirements of this 

2 section, provided that the developer of such instru3 ment or instrument family— 

4 ‘‘(A) maintains documentation that the 

5 new instrument is part of the instrument fam6 ily, as defined in section 587; 

7 ‘‘(B) performs, documents, and maintains 

8 a risk assessment (as described in subsection 

9 (a)(3)(B)(iii)) of the new instrument compared 

10 to the instrument approved under subsection 

11 (b) and no new risks are identified; 

12 ‘‘(C) performs, documents, and maintains 

13 validation and verification activities for the new 

14 instrument; 

15 ‘‘(D) makes such documentation available 

16 to the Secretary upon request; and 

17 ‘‘(E) registers and lists the new instrument 

18 in accordance with section 587J. 

19 ‘‘(2) TEST KITS AND TEST PROTOCOLS.—With 

20 regard to a test kit or test protocol that is approved 

21 under this section for use on an approved instru22 ment or an instrument exempt from premarket re23 view, including an instrument within an instrument 

24 family under this section, a submission under this 

25 section shall not be required for such test kit or test 


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•HR 2369 IH

1 protocol in order for it to be used on a new instru2 ment within its instrument family, provided that— 

3 ‘‘(A) use of the test kit or test protocol 

4 with the new instrument does not— 

5 ‘‘(i) change the claims for the test kit 

6 or test protocol, except as applicable, 

7 claims regarding an instrument or instru8 ments that can be used with such test kit 

9 or test protocol; 

10 ‘‘(ii) adversely affect performance of 

11 the test kit or test protocol; or 

12 ‘‘(iii) cause the test kit or test pro13 tocol to no longer conform with perform14 ance standards required under section 

15 587R or comply with any applicable miti16 gating measures under section 587E, con17 ditions of approval under subsection 

18 (e)(2)(B), or restrictions under section 

19 587O; 

20 ‘‘(B) the test developer does not identify 

21 any new risks for the test kit or test protocol 

22 when using the new instrument after con23 ducting a risk assessment; 

24 ‘‘(C) the test developer validates the use of 

25 the new instrument with the test kit or test 


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•HR 2369 IH

1 protocol and maintains validation documenta2 tion; 

3 ‘‘(D) the test kit or test protocol is not in4 tended for use— 

5 ‘‘(i) in settings for which a certificate 

6 of waiver is in effect under section 353 of 

7 the Public Health Service Act; 

8 ‘‘(ii) without a prescription; 

9 ‘‘(iii) at home; or 

10 ‘‘(iv) in testing donors, donations, and 

11 recipients of blood, blood components, 

12 human cells, tissues, cellular-based prod13 ucts, or tissue-based products; 

14 ‘‘(E) the test developer makes the docu15 mentation described under subparagraph (C) 

16 available to the Secretary upon request; and 

17 ‘‘(F) the test developer updates the listing 

18 information for the test kit or test protocol, as 

19 applicable. 

20 ‘‘(d) AMENDMENTS TO AN APPLICATION.—An appli21 cant shall amend an application submitted under sub22 section (a), (b), or (f) if the applicant becomes aware of 

23 information that could reasonably affect an evaluation 

24 under subsection (e) of whether the approval standard has 

25 been met. 


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•HR 2369 IH

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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•HR 2369 IH

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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•HR 2369 IH

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)(3)(J) 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 

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1 ing the order and summary publicly available, 

2 the Secretary shall not disclose any information 

3 that— 

4 ‘‘(i) is confidential commercial infor5 mation or trade secret information subject 

6 to section 552(b)(4) of title 5, United 

7 States Code, or section 1905 of title 18, 

8 United States Code; or 

9 ‘‘(ii) could compromise national secu10 rity. 

11 ‘‘(3) REVIEW OF DENIALS.—An applicant 

12 whose application submitted under this section has 

13 been denied approval under this subsection may, by 

14 petition filed not more than 60 calendar days after 

15 the date on which the applicant receives notice of 

16 such denial, obtain review of the denial in accord17 ance with section 587P. 

18 ‘‘(f) SUPPLEMENTS TO AN APPROVED APPLICA19 TION.— 

20 ‘‘(1) RISK ANALYSIS.—Prior to implementing 

21 any modification to an in vitro clinical test, the hold22 er of the application approved under subsection (e) 

23 for such test shall perform risk analyses in accord24 ance with this subsection, unless such modification is 

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•HR 2369 IH

1 plicant and approved under this section or exempt 

2 under section 587C. 

3 ‘‘(2) SUPPLEMENT REQUIREMENT.— 

4 ‘‘(A) IN GENERAL.—If the holder of an ap5 plication of an approved in vitro clinical test 

6 makes a modification to such in vitro clinical 

7 test, except as provided in subparagraph (C), or 

8 otherwise specified by the Secretary, the holder 

9 of the application approved under subsection (e) 

10 for an in vitro clinical test shall submit a sup11 plemental application to the Secretary. The 

12 holder of the application may not implement 

13 such modification to the in vitro clinical test 

14 until such supplemental application is approved. 

15 The information required in a supplemental ap16 plication is limited to what is needed to support 

17 the change. 

18 ‘‘(B) CHANGE PROTOCOLS.—The holder of 

19 an approved application may submit under this 

20 paragraph a supplemental application to modify 

21 the change protocol for a test or to request a 

22 change protocol for a test. 

23 ‘‘(C) EXCEPTIONS.—Notwithstanding sub24 paragraphs (A) and (B), and so long as the 

25 holder of an approved application submitted 


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•HR 2369 IH

1 under subsection (a) or (b) for an in vitro clin2 ical test does not add a manufacturing site, or 

3 change activities at an existing manufacturing 

4 site, with respect to the test, the holder of an 

5 approved application may, without submission 

6 of a supplemental application, implement the 

7 following modifications to the test: 

8 ‘‘(i) Modifications in accordance with 

9 an approved change protocol under sub10 section (a)(3)(H). 

11 ‘‘(ii) Modifications that are exempt 

12 under section 587C(a)(6). 

13 ‘‘(iii) Labeling changes that are ap14 propriate to address a safety concern, ex15 cept such labeling changes that include any 

16 of the following remain subject to subpara17 graph (A): 

18 ‘‘(I) A change to the indications 

19 for use of the test. 

20 ‘‘(II) A change to the perform21 ance claims made with respect to the 

22 test. 

23 ‘‘(III) A change that adversely 

24 affects performance of the test. 


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•HR 2369 IH

1 ‘‘(D) REPORTING FOR CERTAIN MODIFICA2 TIONS MADE PURSUANT TO A CHANGE PRO3 TOCOL.—The holder of an application approved 

4 under subsection (e), with an approved change 

5 protocol under subsection (a)(2)(H) for such in 

6 vitro clinical test shall— 

7 ‘‘(i) report any modification to such 

8 test made pursuant to such change pro9 tocol approved under subsection (a)(3)(H) 

10 in a submission under section 

11 587J(c)(2)(B); and 

12 ‘‘(ii) include in such report— 

13 ‘‘(I) a description of the modi14 fication; 

15 ‘‘(II) the rationale for imple16 menting such modification; and 

17 ‘‘(III) as applicable, a summary 

18 of the evidence supporting that the 

19 test, as modified, meets the applicable 

20 standard, complies with performance 

21 standards required under section 

22 587Q, and complies with any miti23 gating measures established under 

24 section 587E and any restrictions 

25 under section 587O. 


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1 ‘‘(E) REPORTING FOR CERTAIN SAFETY

2 RELATED LABELING CHANGES.—The holder of 

3 the application for an in vitro clinical test ap4 proved under subsection (e) shall— 

5 ‘‘(i) report to the Secretary any modi6 fication to the test described in subpara7 graph (C)(iii) not more than 30 days after 

8 the date on which the test, with the modi9 fication, is introduced into interstate com10 merce; and 

11 ‘‘(ii) include in the report— 

12 ‘‘(I) a description of the change 

13 or changes; 

14 ‘‘(II) the rationale for imple15 menting such change or changes; and 

16 ‘‘(III) a description of how the 

17 change or changes were evaluated. 

18 ‘‘(3) CONTENTS OF SUPPLEMENT.—Unless oth19 erwise specified by the Secretary, a supplement 

20 under this subsection shall include— 

21 ‘‘(A) for modifications other than manufac22 turing site changes requiring a supplement— 

23 ‘‘(i) a description of the modification; 

24 ‘‘(ii) data relevant to the modification 

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1 ard is met, not to exceed data require2 ments for the original submission; 

3 ‘‘(iii) acceptance criteria; and 

4 ‘‘(iv) any revised labeling; and 

5 ‘‘(B) for manufacturing site changes— 

6 ‘‘(i) the information listed in subpara7 graph (A); and 

8 ‘‘(ii) information regarding the meth9 ods used in, or the facilities or controls 

10 used for, the development of the test to 

11 demonstrate compliance with the applicable 

12 quality requirements under section 587K. 

13 ‘‘(4) ADDITIONAL DATA.—The Secretary may 

14 require, when necessary, data to evaluate a modifica15 tion to an in vitro clinical test that is in addition to 

16 the data otherwise required under the preceding 

17 paragraphs if the data request is in accordance with 

18 the least burdensome requirements under section 

19 587AA(c). 

20 ‘‘(5) CONDITIONS OF APPROVAL.—In an order 

21 approving a supplement under this subsection, the 

22 Secretary may require conditions of approval for the 

23 in vitro clinical test, including compliance with re24 strictions under section 587O and conformance to 

25 performance standards under section 587R. 


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1 ‘‘(6) APPROVAL.—The Secretary shall approve 

2 a supplement under this subsection if— 

3 ‘‘(A) the data demonstrate that the modi4 fied in vitro clinical test meets the applicable 

5 standard; and 

6 ‘‘(B) the holder of the application approved 

7 under subsection (e) for the test has dem8 onstrated compliance with applicable quality 

9 and inspection requirements, as applicable and 

10 appropriate. 

11 ‘‘(7) PUBLICATION.—The Secretary shall pub12 lish on the public website of the Food and Drug Ad13 ministration notice of any order approving a supple14 ment under this subsection provided that doing so 

15 does not disclose any information that— 

16 ‘‘(A) is trade secret or confidential com17 mercial or financial information; or 

18 ‘‘(B) could compromise national security. 

19 ‘‘(8) REVIEW OF DENIAL.—An applicant whose 

20 supplement under this subsection has been denied 

21 approval may, by petition filed on or before the 60th 

22 calendar day after the date upon which the applicant 

23 receives notice of such denial, obtain review of the 

24 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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•HR 2369 IH

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 provided that doing so does not 

2 disclose— 

3 ‘‘(i) any information that is trade se4 cret or confidential commercial or financial 

5 information; or 

6 ‘‘(ii) any other information that the 

7 Secretary determines, if published, could 

8 compromise national security. 

9 ‘‘(2) ORDER OF TEMPORARY SUSPENSION.—If, 

10 after providing due notice and an opportunity for an 

11 informal hearing to the holder of an approved appli12 cation for an in vitro clinical test under this section, 

13 the Secretary determines, based on scientific evi14 dence, that there is a reasonable likelihood that the 

15 in vitro clinical test would cause death or serious ad16 verse health consequences, such as by causing the 

17 absence, significant delay, or discontinuation of life18 saving or life-sustaining medical treatment, the Sec19 retary shall, by order, temporarily suspend the ap20 proval of the application. If the Secretary issues 

21 such an order, the Secretary shall proceed expedi22 tiously under paragraph (1) to withdraw approval of 

23 such application. 

24 ‘‘(3) APPEAL WITHDRAWING APPROVAL AND

25 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 offered subject to other appli7 cable 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 offered sub12 ject to the other applicable requirements of this 

13 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)(aa) was offered for clinical use 

2 prior to the date of enactment of the 

3 VALID Act of 2023; and 

4 ‘‘(bb) 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 ‘‘(II)(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 2023 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 2023, 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 offered sub5 ject to the other applicable requirements of this 

6 Act, including section 587J(b), if such test 

7 meets the definition of low-risk under section 

8 587 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 subparagraph (B); 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 falls 

2 within a category of tests listed as de3 scribed in subparagraph (C). 

4 ‘‘(C) LIST OF LOW-RISK TESTS.— 

5 ‘‘(i) IN GENERAL.—The Secretary 

6 shall maintain, and make publicly available 

7 on the website of the Food and Drug Ad8 ministration, a list of in vitro clinical tests, 

9 and categories of in vitro clinical tests, 

10 that are low-risk in vitro clinical tests for 

11 purposes of the exemption under this para12 graph. 

13 ‘‘(ii) INCLUSION.—The list under 

14 clause (i) shall consist of— 

15 ‘‘(I) all in vitro clinical tests and 

16 categories of in vitro clinical tests that 

17 are exempt from premarket review 

18 pursuant to paragraph (1) or this 

19 paragraph; and 

20 ‘‘(II) all in vitro clinical tests and 

21 categories of in vitro clinical tests that 

22 are designated by the Secretary pur23 suant to subparagraph (D) as low-risk 

24 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— 


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1 ‘‘(I) a noncontagious disease or 

2 condition that affects not more than 

3 10,000 (or such other higher number 

4 determined by the Secretary) individ5 uals in the United States per year; or 

6 ‘‘(II) a contagious disease or con7 dition that affects not more than 

8 1,500 individuals in the United States 

9 per year; 

10 ‘‘(ii) the in vitro clinical test meets 

11 the applicable standard described in sec12 tion 587(2); 

13 ‘‘(iii) the labeling and advertising for 

14 the in vitro clinical test are not false or 

15 misleading; 

16 ‘‘(iv) the in vitro clinical test is not 

17 likely to cause or contribute to serious ad18 verse health consequences; and 

19 ‘‘(v) the in vitro clinical test is not in20 tended for screening. 

21 ‘‘(C) EXCEPTION FOR CERTAIN TESTS.— 

22 An in vitro clinical test intended to inform the 

23 use of a specific individual or specific type of bi24 ological product, drug, or device shall be eligible 

25 for an exemption from premarket review under 


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1 this subsection only if, the developer submits a 

2 request under section 587F(e) for informal 

3 feedback and the Secretary determines that 

4 such in vitro clinical test is eligible for an ex5 emption from premarket review under this sub6 section. 

7 ‘‘(4) CUSTOM TESTS AND LOW-VOLUME

8 TESTS.—An in vitro clinical test is exempt from pre9 market review under section 587B, quality require10 ments under section 587K, and listing requirements 

11 under section 587J, and may be lawfully offered 

12 subject to the other applicable requirements of this 

13 Act, if— 

14 ‘‘(A) such in vitro clinical test— 

15 ‘‘(i) is a test protocol performed for 

16 not more than 5 patients per year (or such 

17 other higher number determined by the 

18 Secretary), in a laboratory certified by the 

19 Secretary under section 353 of the Public 

20 Health Service Act that— 

21 ‘‘(I) meets the requirements to 

22 perform tests of high-complexity in 

23 which the test protocol was developed; 

24 or 


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1 ‘‘(II) meets the requirements to 

2 perform tests of high-complexity with3 in the same corporate organization 

4 and having common ownership by the 

5 same parent corporation as the lab6 oratory in which such test protocol 

7 was developed; or 

8 ‘‘(ii) is an in vitro clinical test devel9 oped to diagnose a unique pathology or 

10 physical condition of a specific patient or 

11 patients (including an in vitro clinical test 

12 modified for such purpose), upon the pre13 scription or order of a health care practi14 tioner licensed to prescribe or order such 

15 test, or a health care professional or other 

16 specially qualified person designated under 

17 regulations to prescribe or order such test, 

18 for which no other in vitro clinical test is 

19 commercially available in the United 

20 States, and is— 

21 ‘‘(I) not intended for use with re22 spect to more than 5 (or such other 

23 higher number determined by the Sec24 retary) other patients; and 


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1 ‘‘(II) not included in any test 

2 menu or template test report or other 

3 promotional materials, and is not oth4 erwise advertised; and 

5 ‘‘(B) the developer of the in vitro clinical 

6 test— 

7 ‘‘(i) maintains documentation dem8 onstrating that such test meets the appli9 cable criteria described in subparagraph 

10 (A); 

11 ‘‘(ii) makes such documentation, such 

12 as a prescription order requesting the cus13 tom test for an individual patient, available 

14 to the Secretary upon request; and 

15 ‘‘(iii) informs the Secretary, on an an16 nual basis, in a manner prescribed by the 

17 Secretary by guidance, that such test was 

18 offered. 

19 ‘‘(5) IN VITRO CLINICAL TESTS UNDER A TECH20 NOLOGY CERTIFICATION ORDER.—An in vitro clin21 ical test that is within the scope of a technology cer22 tification order under section 587D is exempt from 

23 premarket review under section 587B. 

24 ‘‘(6) MODIFIED TESTS.— 


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1 ‘‘(A) IN GENERAL.—An in vitro clinical 

2 test that is modified is exempt from premarket 

3 review under section 587B if— 

4 ‘‘(i) the modification is made by— 

5 ‘‘(I) the developer that obtained 

6 premarket approval for the unmodi7 fied version of the test under section 

8 587B; or 

9 ‘‘(II) a clinical laboratory cer10 tified by the Secretary under section 

11 353 of the Public Health Service Act 

12 that meets the requirements for per13 forming high complexity testing, to a 

14 lawfully offered in vitro clinical test, 

15 including another developer’s lawfully 

16 offered in vitro clinical test, excluding 

17 investigational in vitro clinical tests 

18 offered under section 587S, and the 

19 modified test is performed— 

20 ‘‘(aa) in the same clinical 

21 laboratory in which it was devel22 oped for which a certification is 

23 still in effect under section 353 

24 that meets the requirements to 

25 perform tests of high complexity; 


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1 ‘‘(bb) by another clinical lab2 oratory for which a certificate is 

3 in effect under section 353 that 

4 meets the requirements to per5 form tests of high complexity, is 

6 within the same corporate organi7 zation, and has common owner8 ship by the same parent corpora9 tion as the laboratory in which 

10 the test was developed; or 

11 ‘‘(cc) by a clinical laboratory 

12 for which a certificate is in effect 

13 under section 353 that meets the 

14 requirements to perform tests of 

15 high complexity and is within a 

16 public health laboratory network 

17 coordinated or managed by the 

18 Centers for Disease Control and 

19 Prevention, if the test was devel20 oped by the Centers for Disease 

21 Control and Prevention or an22 other laboratory within such pub23 lic health laboratory network; 

24 ‘‘(ii) the modification does not— 


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1 ‘‘(I) constitute a significant 

2 change to the indications for use, ex3 cept for changes to a specimen type, 

4 as specified in the guidance issued 

5 under subparagraph (E); 

6 ‘‘(II) cause the test to no longer 

7 comply with applicable mitigating 

8 measures under section 587E or re9 strictions under section 587O; 

10 ‘‘(III) significantly change per11 formance claims or significantly and 

12 adversely change performance, unless 

13 provided for under an approved 

14 change protocol under section 

15 587B(a)(3)(H); or 

16 ‘‘(IV) constitute an adverse 

17 change in the safety of the in vitro 

18 clinical test for individuals who come 

19 in contact with the in vitro clinical 

20 test; 

21 ‘‘(iii) the test meets the applicable 

22 standard as described in section 587(2); 

23 ‘‘(iv) the labeling and advertising are 

24 not false or misleading; and 


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1 ‘‘(v) the test is not likely to cause or 

2 contribute to serious adverse health con3 sequences. 

4 ‘‘(B) CERTAIN MODIFICATIONS.—A modi5 fication to extend specimen stability is exempt 

6 from premarket review under section 587B if 

7 the modified test meets the requirements in 

8 clauses (ii) through (v) of subparagraph (A). 

9 ‘‘(C) MODIFICATIONS UNDER A CHANGE

10 PROTOCOL.—Notwithstanding subparagraph 

11 (A), a modification made under a change pro12 tocol pursuant to subsection (a)(2)(H) of sec13 tion 587B is exempt from review under such 

14 section. 

15 ‘‘(D) DOCUMENTATION.—A person who 

16 modifies an in vitro clinical test in a manner 

17 that is a modification described in this para18 graph shall— 

19 ‘‘(i) document the modification that 

20 was made and the basis for determining 

21 that the modification, considering the 

22 changes individually and collectively, is a 

23 type of modification described in subpara24 graph (A), (B), or (C); and 


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1 ‘‘(ii) provide such documentation to 

2 the Secretary upon request or inspection. 

3 ‘‘(E) GUIDANCE.—Not later than 30 

4 months after the date of enactment of the 

5 VALID Act of 2023, the Secretary shall issue 

6 guidance regarding the in vitro clinical tests 

7 that are modified and exempt from premarket 

8 review under section 587B pursuant to this 

9 paragraph. Such guidance shall include consid10 erations for changes to a specimen type that 

11 may be made by a developer without the re12 quirement of premarket review under 587B. 

13 ‘‘(b) MANUAL TESTS.— 

14 ‘‘(1) EXEMPTION.—An in vitro clinical test is 

15 exempt from all requirements of this subchapter if 

16 the output of such in vitro clinical test is the result 

17 of direct, manual observation, without the use of 

18 automated instrumentation or software for inter19 mediate or final interpretation, by a qualified labora20 tory professional, and such in vitro clinical test— 

21 ‘‘(A) is developed and used within a single 

22 clinical laboratory for which a certificate is in 

23 effect under section 353 of the Public Health 

24 Service Act that meets the requirements under 


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1 section 353 for performing high-complexity test2 ing; 

3 ‘‘(B) is not a specimen receptacle, instru4 ment, or an in vitro clinical test that includes 

5 an instrument or specimen receptacle that is 

6 not approved under or exempt from section 

7 587B; 

8 ‘‘(C) is not a high-risk test, or is a high9 risk test that the Secretary has determined 

10 meets at least one condition in paragraph (2) 

11 and is otherwise appropriate for this exemption; 

12 and 

13 ‘‘(D) is not intended for testing donors, 

14 donations, or recipients of blood, blood compo15 nents, human cells, tissues, cellular-based prod16 ucts, or tissue-based products. 

17 ‘‘(2) HIGH-RISK TEST LIMITATION OR CONDI18 TION.—A high-risk test may be exempt under para19 graph (1) from the requirements of this subchapter 

20 only if— 

21 ‘‘(A) no components or parts of such test, 

22 including any reagent, is introduced into inter23 state commerce under the exemption under sub24 section (e), and any article for taking or deriv25 ing specimens from the human body used in 


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1 conjunction with the test remains subject to the 

2 requirements of this subchapter; or 

3 ‘‘(B) the test has been developed in accord4 ance with the applicable test design and quality 

5 requirements under section 587K. 

6 ‘‘(c) PUBLIC HEALTH SURVEILLANCE ACTIVITIES.— 

7 ‘‘(1) IN GENERAL.—The provisions of this sub8 chapter shall not apply to a test intended by the de9 veloper to be used solely for public health surveil10 lance activities. 

11 ‘‘(2) EXCLUSION.—An in vitro clinical test used 

12 for public health surveillance activities is not ex13 cluded from the provisions of this subchapter pursu14 ant to this subsection if such test is intended for use 

15 in making clinical decisions for individual patients. 

16 ‘‘(d) GENERAL LABORATORY EQUIPMENT.—As set 

17 forth in section 201(ss)(3)(C), general purposes laboratory 

18 equipment is not an in vitro clinical tests and is not sub19 ject to the requirements of this subchapter. 

20 ‘‘(e) COMPONENTS AND PARTS.— 

21 ‘‘(1) IN GENERAL.—Subject to paragraph (2), a 

22 component or part described in section 

23 201(ss)(2)(G) is— 


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1 ‘‘(A) exempt from the requirements of this 

2 subchapter if it is intended for further develop3 ment as described in paragraph (3); or 

4 ‘‘(B) subject to the requirements of this 

5 subchapter and regulated based on its risk 

6 when used as intended by the developer, not7 withstanding its subsequent use by a developer 

8 as a component, part, or raw material of an9 other in vitro clinical test. 

10 ‘‘(2) INAPPLICABILITY TO OTHER TESTS.—Not11 withstanding paragraph (1), an in vitro clinical test 

12 that is described in section 201(ss)(1)(B) and that 

13 uses a component or part described in such subpara14 graph shall be subject to the requirements of this 

15 subchapter, unless the test is otherwise exempt 

16 under this section. 

17 ‘‘(3) FURTHER DEVELOPMENT.—A component, 

18 part, or raw material (as described in paragraph 

19 (1)) is intended for further development (for pur20 poses of such paragraph) if— 

21 ‘‘(A) it is intended solely for use in the de22 velopment of another in vitro clinical test; and 

23 ‘‘(B) in the case of such a test that is in24 troduced or delivered for introduction into 

25 interstate commerce after the date of enactment 


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1 of the VALID Act of 2023, the labeling of such 

2 test bears the following statement: ‘This prod3 uct is intended solely for further development of 

4 an in vitro clinical test and is exempt from 

5 FDA regulation. This product must be evalu6 ated by the in vitro clinical test developer if it 

7 is used with or in the development of an in vitro 

8 clinical test.’. 

9 ‘‘(f) GENERAL EXEMPTION AUTHORITY.—The Sec10 retary may, by order published in the Federal Register 

11 following notice and an opportunity for comment, exempt 

12 a class of persons from any section under this subchapter 

13 upon a finding that such exemption is appropriate for the 

14 protection of the public health and other relevant consider15 ations. 

16 ‘‘(g) OTHER EXEMPTIONS.—An in vitro clinical test 

17 that is intended solely for use in forensic analysis or law 

18 enforcement activity is exempt from the requirements of 

19 this subchapter. An in vitro clinical test that is intended 

20 for use in making clinical decisions for individual patients, 

21 or whose individually identifiable results may be reported 

22 back to an individual patient or the patient’s health care 

23 provider, even if also intended for forensic analysis or law 

24 enforcement purposes, is not intended solely for forensic 


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1 analysis or law enforcement for purposes of this sub2 section. 

3 ‘‘(h) REVOCATION.— 

4 ‘‘(1) IN GENERAL.—The Secretary may revoke 

5 any exemption under this section with respect to in 

6 vitro clinical tests with the same indications for use 

7 if new clinical information indicates that the exemp8 tion of an in vitro clinical test or tests from pre9 market review under section 587B has a reasonable 

10 probability of severe adverse health consequences, in11 cluding the absence, delay, or discontinuation of ap12 propriate medical treatment. 

13 ‘‘(2) PROCESS.—Any action under paragraph 

14 (1) shall be made by publication of a notice of such 

15 proposed action on the website of the Food and 

16 Drug Administration, the consideration of comments 

17 to a public docket on such proposal, and publication 

18 of a final action on such website within 60 calendar 

19 days of the close of the comment period posted to 

20 such public docket, notwithstanding subchapter II of 

21 chapter 5 of title 5, United States Code. 

22 ‘‘(i) PRE-ANALYTICAL INSTRUMENT.—A pre-analyt23 ical instrument is exempt from premarket review under 

24 section 587B and may be lawfully offered subject to the 


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1 other applicable requirements of this Act, if either of the 

2 following applies: 

3 ‘‘(1) Such instrument provides additional infor4 mation regarding the sample or performs an action 

5 on the sample but is not preparing or processing the 

6 sample and does not perform any function of an an7 alytical instrument. Such types of pre-analytical in8 struments include barcode readers, sample movers, 

9 and sample identifiers. 

10 ‘‘(2) Such instrument processes or prepares the 

11 sample prior to use on an analytical instrument, 

12 does not perform any function of an analytical in13 strument, and does not select, isolate, or prepare a 

14 part of a sample based on specific properties. Such 

15 types of pre-analytical instruments may include sam16 ple mixers, DNA extractors and those used to dilute 

17 samples. 

18 ‘‘SEC. 587D. TECHNOLOGY CERTIFICATION. 

19 ‘‘(a) DEFINITIONS.—In this section: 

20 ‘‘(1) ELIGIBLE IN VITRO CLINICAL TEST.—The 

21 term ‘eligible in vitro clinical test’ means an in vitro 

22 clinical test that is not— 

23 ‘‘(A) a component or part of an in vitro 

24 clinical test as described in section 

25 201(ss)(2)(G) unless it is a component or part 


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1 and is regulated based on its own risk under 

2 section 587C(e)(1)(B) or as part of an other3 wise eligible in vitro clinical test; 

4 ‘‘(B) an instrument under section 

5 201(ss)(2)(D) or an in vitro clinical test that 

6 includes an instrument that is subject to section 

7 587B, but is not approved under, or exempt 

8 from, section 587B; 

9 ‘‘(C) a specimen receptacle under section 

10 201(ss)(2)(E) or an in vitro clinical test that 

11 includes a specimen receptacle that is subject to 

12 section 587B, but is not approved under, or ex13 empt from, section 587B; 

14 ‘‘(D) an in vitro clinical test, including re15 agents used in such tests, intended for use for 

16 testing donors, donations, and recipients of 

17 blood, blood components, human cells, tissues, 

18 cellular-based products, or tissue-based prod19 ucts; 

20 ‘‘(E) high-risk; 

21 ‘‘(F) a combination product, unless such 

22 test has been determined to be eligible to be in23 troduced into interstate commerce under a tech24 nology certification order pursuant to the regu25 latory pathway designation process described in 


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1 section 587F, or as described in subsection (k), 

2 and the drug or biological product constituent 

3 part complies with the requirements of section 

4 503(g) applicable to the drug or biological prod5 uct; or 

6 ‘‘(G) a first-of-a-kind in vitro clinical test, 

7 unless such test has been determined to be eli8 gible to be introduced into interstate commerce 

9 under a technology certification order pursuant 

10 to the regulatory pathway designation process 

11 described in section 587F, or as described in 

12 subsection (k). 

13 ‘‘(2) ELIGIBLE PERSON.—The term ‘eligible 

14 person’ means an in vitro clinical test developer un15 less such developer— 

16 ‘‘(A) is a laboratory subject to section 353 

17 of the Public Health Service Act and does not 

18 have in effect a certificate applicable to the cat19 egory of laboratory examination or other proce20 dure; 

21 ‘‘(B) was a laboratory, or an owner or op22 erator or any employee of a laboratory, found 

23 to have committed a significant violation of sec24 tion 353 of the Public Health Service Act that 

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1 tificate within the 2-year period preceding the 

2 date of the submission of the application for a 

3 technology certificate under subsection (c) and 

4 such violation has not been resolved; or 

5 ‘‘(C) has been found to have submitted in6 formation to the Secretary, or otherwise dis7 seminated information, that— 

8 ‘‘(i) made false or misleading state9 ments relevant to the requirements of this 

10 subchapter; or 

11 ‘‘(ii) violated any requirement of this 

12 Act, where such violation exposed individ13 uals to serious risk of illness, injury, or 

14 death, unless— 

15 ‘‘(I) such violation has been re16 solved; or 

17 ‘‘(II) such violation is not perti18 nent to any in vitro clinical test within 

19 the scope of the technology certifi20 cation that such developer seeks. 

21 ‘‘(b) APPLICABILITY.— 

22 ‘‘(1) IN GENERAL.—An in vitro clinical test is 

23 not subject to section 587B and may be introduced 

24 into interstate commerce if the in vitro clinical 

25 test— 


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1 ‘‘(A) is an eligible in vitro clinical test; 

2 ‘‘(B) is developed by an eligible person; 

3 ‘‘(C) falls within the scope of a technology 

4 certification order issued under this section and 

5 that is in effect; 

6 ‘‘(D) complies with the conditions of the 

7 technology certification order, including with 

8 applicable mitigating measures under section 

9 587E, restrictions under section 587O, and per10 formance standards under section 587R; and 

11 ‘‘(E) meets the applicable standard de12 scribed in section 587(2). 

13 ‘‘(2) SCOPE.— 

14 ‘‘(A) IN GENERAL.—Subject to subpara15 graph (B), the scope of a technology certifi16 cation order issued under this section shall 

17 apply to one or more technologies with multiple 

18 in vitro clinical tests utilizing a technology that 

19 does not significantly differ in control mecha20 nisms, energy sources, or operating principles 

21 and for which development, including design, 

22 and analytical and clinical validation, of the in 

23 vitro clinical tests would be addressed through 

24 similar procedures, and be no broader than— 

25 ‘‘(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 that eligible in vitro 

13 clinical tests within the proposed scope of the 

14 technology certification order are analytically 

15 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; 

13 ‘‘(ii) the information specified in sub14 section (a) or (b) of section 587B, as ap15 plicable, for the representative in vitro clin16 ical test or tests, unless the Secretary de17 termines that such information is not nec18 essary; 

19 ‘‘(iii) a summary of a risk assessment 

20 of the in vitro clinical test; 

21 ‘‘(iv) an explanation of the choice of 

22 the representative in vitro clinical test or 

23 tests for the technology certification appli24 cation and how such test adequately dem25 onstrates the range of procedures that the 


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1 developer includes in the application under 

2 subparagraphs (F), (G), (H), and (I); and 

3 ‘‘(v) a brief explanation of the ways in 

4 which the procedures included in the appli5 cation under subparagraphs (F), (G), (H), 

6 and (I) have been applied to the represent7 ative in vitro clinical test or tests; and 

8 ‘‘(K) such other information necessary to 

9 make a determination on a technology certifi10 cation application as the Secretary may deter11 mine necessary. 

12 ‘‘(3) REFERENCE TO EXISTING APPLICA13 TIONS.—With respect to the content requirements in 

14 the technology certification application described in 

15 paragraph (2), a developer may incorporate by ref16 erence any content of an application previously sub17 mitted by the developer. 

18 ‘‘(d) ACTION ON AN APPLICATION FOR TECHNOLOGY

19 CERTIFICATION.— 

20 ‘‘(1) SECRETARY RESPONSE.— 

21 ‘‘(A) IN GENERAL.—As promptly as prac22 ticable, and not later than 90 days after receipt 

23 of an application under subsection (c), the Sec24 retary shall— 


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1 ‘‘(i) if the Secretary finds that all of 

2 the grounds in paragraph (3) are met, 

3 issue a technology certification order 

4 granting the application, which— 

5 ‘‘(I) may include reasonable con6 ditions of certification; and 

7 ‘‘(II) shall specify the scope of 

8 the technology certification; or 

9 ‘‘(ii) deny the application, if the Sec10 retary finds (and sets forth the basis of 

11 such finding as part of or accompanying 

12 such denial) that one or more grounds for 

13 granting the application specified in para14 graph (3) are not met. 

15 ‘‘(B) EXTENSION.—The timeline described 

16 in subparagraph (A) may be extended by mu17 tual agreement between the Secretary and the 

18 applicant. 

19 ‘‘(2) DEFICIENT APPLICATIONS.— 

20 ‘‘(A) IN GENERAL.—If, after receipt of an 

21 application under this section, the Secretary de22 termines that any portion of such application is 

23 deficient, the Secretary, not later than 60 days 

24 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 a technology 

24 certification order, a supplemental application 

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1 mitted by the holder of the technology certifi2 cation order describing such proposed changes, 

3 and the in vitro clinical test with such changes 

4 may not be introduced into interstate commerce 

5 until a technology certification order for such 

6 supplemental application is granted: 

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). 

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 2023, 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, issued, 

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 issued technology cer20 tification 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 9 of the VALID Act of 2023. 

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 2023, 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 2023, 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 587 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 587; 

16 ‘‘(ii) is not eligible to be introduced 

17 into interstate commerce under any of sub18 paragraphs (A) through (E) of subsection 

19 (a)(1); or 

20 ‘‘(iii) is not eligible to be introduced 

21 into interstate commerce under the ref22 erenced technology certification order 

23 issued by the Secretary because it is not 

24 within the scope of the technology certifi25 cation order under subsection (b)(2); or 


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1 ‘‘(B) based on the information included in 

2 the notification submitted by the developer pur3 suant to this subsection, there is insufficient in4 formation for the Secretary to make the deter5 minations described in clauses (i), (ii), and (iii) 

6 of subparagraph (A). 

7 ‘‘SEC. 587E. MITIGATING MEASURES. 

8 ‘‘(a) ESTABLISHMENT OF MITIGATING MEASURES.— 

9 ‘‘(1) ESTABLISHING, CHANGING, OR WITH10 DRAWING.— 

11 ‘‘(A) ESTABLISHMENT.—The Secretary 

12 may establish and require, on the basis of evi13 dence, mitigating measures for any in vitro clin14 ical test or category of in vitro clinical tests 

15 with the same indications for use that is intro16 duced or delivered for introduction into inter17 state commerce after the Secretary establishes 

18 any such mitigating measures. 

19 ‘‘(B) METHODS OF ESTABLISHMENT.—The 

20 Secretary may establish mitigating measures— 

21 ‘‘(i) under the process set forth in 

22 subparagraph (D); 

23 ‘‘(ii) as provided under section 587F; 

24 or 


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1 ‘‘(iii) through a premarket approval or 

2 technology certification order, which may 

3 establish mitigating measures for an indi4 vidual in vitro clinical test or a category of 

5 in vitro clinical tests. 

6 ‘‘(C) METHODS OF CHANGE OR WITH7 DRAWAL.—The Secretary may change or with8 draw mitigating measures— 

9 ‘‘(i) under the process set forth in 

10 subparagraph (D); or 

11 ‘‘(ii) as provided under section 587F. 

12 ‘‘(D) PROCESS FOR ESTABLISHMENT, 

13 CHANGE, OR WITHDRAWAL.—Notwithstanding 

14 subchapter II of chapter 5 of title 5, United 

15 States Code, the Secretary may, upon the ini16 tiative of the Secretary or upon petition of an 

17 interested person, establish, change, or with18 draw mitigating measures for an in vitro clin19 ical test or category of in vitro clinical tests 

20 by— 

21 ‘‘(i) publishing a proposed order in 

22 the Federal Register; 

23 ‘‘(ii) providing an opportunity for 

24 public comment for a period of not less 

25 than 30 60 calendar days; and 


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1 ‘‘(iii) after consideration of any com2 ments submitted, publishing a final order 

3 in the Federal Register that responds to 

4 the comments submitted, and which shall 

5 include a reasonable transition period. 

6 ‘‘(E) EFFECT OF MITIGATING MEASURES

7 ON GRANDFATHERED TESTS.—A mitigating 

8 measure shall not be required by the Secretary 

9 for an in vitro clinical test subject to section 

10 587G(a). 

11 ‘‘(2) IN VITRO CLINICAL TESTS PREVIOUSLY

12 CLEARED OR EXEMPT AS DEVICES WITH SPECIAL

13 CONTROLS.— 

14 ‘‘(A) IN GENERAL.—Any special controls 

15 applicable to an in vitro clinical test previously 

16 cleared or exempt under section 510(k), or clas17 sified under section 513(f)(2) prior to date of 

18 enactment of the VALID Act of 2023, including 

19 any such special controls established during the 

20 period beginning on the date of enactment of 

21 the VALID Act of 2023 and ending on the ef22 fective date of such Act (as described in section 

23 5(b) of such Act)— 


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1 ‘‘(i) shall continue to apply to such in 

2 vitro clinical test after such effective date; 

3 and 

4 ‘‘(ii) are deemed to be mitigating 

5 measures as of the effective date specified 

6 in section 5(a)(1)(A) of the VALID Act of 

7 2023. 

8 ‘‘(B) CHANGES.—Notwithstanding sub9 paragraph (A), the Secretary may establish, 

10 change, or withdraw mitigating measures for 

11 such tests or category of tests using the proce12 dures under paragraph (1). 

13 ‘‘(b) DOCUMENTATION.— 

14 ‘‘(1) IN VITRO CLINICAL TESTS SUBJECT TO

15 PREMARKET REVIEW.—The developer of an in vitro 

16 clinical test subject to premarket review under sec17 tion 587B and to which mitigating measures apply 

18 shall maintain documentation in accordance with the 

19 applicable quality requirements under section 587K 

20 and make such documentation available to the Sec21 retary upon request or inspection. 

22 ‘‘(2) OTHER TESTS.—The developer of an in 

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1 market review under section 587B and to which 

2 mitigating measures apply shall— 

3 ‘‘(A) maintain documentation in accord4 ance with the applicable quality requirements 

5 under section 587K demonstrating that such 

6 mitigating measures continue to be met fol7 lowing a test modification by the developer; 

8 ‘‘(B) make such documentation available to 

9 the Secretary upon request or inspection; and 

10 ‘‘(C) include in the performance summary 

11 for such test a brief description of how such 

12 mitigating measures are met, if applicable. 

13 ‘‘SEC. 587F. REGULATORY PATHWAY DESIGNATION. 

14 ‘‘(a) PATHWAY DETERMINATIONS.— 

15 ‘‘(1) IN GENERAL.—After considering available 

16 evidence with respect to an in vitro clinical test or 

17 category of in vitro clinical tests with the same in18 tended use, including the identification, establish19 ment under paragraph (4), and implementation of 

20 mitigating measures under section 587E, as appro21 priate, the Secretary may, upon the initiative of the 

22 Secretary or upon request of a developer, determine 

23 that— 


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1 ‘‘(A) such in vitro clinical test is high-risk 

2 and subject to premarket review under section 

3 587B; 

4 ‘‘(B) such in vitro clinical tests, including 

5 a first-of-a-kind test, is moderate-risk and sub6 ject to abbreviated premarket review under sec7 tion 587B(b) or technology certification under 

8 section 587D(a)(1); or 

9 ‘‘(C) such in vitro clinical test, including a 

10 first-of-a-kind test is low-risk or otherwise ex11 empt from premarket review under section 

12 587B. 

13 ‘‘(2) REQUESTS.— 

14 ‘‘(A) SUBMISSIONS BY DEVELOPERS.— 

15 ‘‘(i) ABBREVIATED PREMARKET RE16 VIEW; TECHNOLOGY CERTIFICATION.—A 

17 developer submitting a request that the 

18 Secretary make a determination as de19 scribed in paragraph (1)(B) shall submit 

20 information to support that the in vitro 

21 clinical test is moderate-risk or propose 

22 mitigating measures, if applicable, that 

23 would support such a determination. 

24 ‘‘(ii) LOW-RISK; EXEMPT FROM PRE25 MARKET REVIEW.—A developer submitting 


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1 a request that the Secretary make a deter2 mination as described in paragraph (1)(C) 

3 shall submit information that the in vitro 

4 clinical test is low-risk, or otherwise appro5 priate for exemption from premarket re6 view under section 587B and propose miti7 gating measures, if applicable, that would 

8 support such a determination. 

9 ‘‘(B) RESPONSE BY THE SECRETARY.— 

10 Not later than 30 days after receiving a request 

11 under clause (i) or (ii) of subparagraph (A), the 

12 Secretary shall provide a timely response de13 scribing whether or not the Secretary will ini14 tiate the process for making a determination 

15 under paragraph (1)(B) or (1)(C) as described 

16 in paragraph (4). 

17 ‘‘(3) SUFFICIENCY OF MITIGATING MEAS18 URES.—When determining whether mitigating meas19 ures for an in vitro clinical test, or category of in 

20 vitro clinical tests, are sufficient to make such test 

21 moderate-risk or low-risk, the Secretary shall take 

22 into account the following: 

23 ‘‘(A) The degree to which the technology 

24 for the intended use of the in vitro clinical test 

25 is well-characterized, taking into consideration 


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1 factors that include one or more of the fol2 lowing: 

3 ‘‘(i) Peer-reviewed literature. 

4 ‘‘(ii) Practice guidelines. 

5 ‘‘(iii) Consensus standards. 

6 ‘‘(iv) Recognized standards of care. 

7 ‘‘(v) Use of such technology, including 

8 historical use. 

9 ‘‘(vi) Multiple scientific publications 

10 by different authors. 

11 ‘‘(vii) Adoption by the scientific or 

12 clinical community. 

13 ‘‘(viii) Real world evidence. 

14 ‘‘(B) Whether the criteria for performance 

15 of the test are well-established to be sufficient 

16 for the intended use. 

17 ‘‘(C) The clinical circumstances under 

18 which the in vitro clinical test is used, including 

19 whether the in vitro clinical test is the sole de20 terminate for the diagnosis or treatment of the 

21 targeted disease, and the availability of other 

22 tests (such as confirmatory or adjunctive tests) 

23 or relevant material standards. 

24 ‘‘(D) Whether such mitigating measures 

25 sufficiently mitigate the risk of harm such that 


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1 the test or category of tests is moderate-risk or 

2 low-risk. 

3 ‘‘(4) PROCESS.— 

4 ‘‘(A) IN GENERAL.—For a test that is not 

5 first-of-a-kind, any action under paragraph (1) 

6 shall be made by publication of a notice of such 

7 proposed action on the website of the Food and 

8 Drug Administration, the consideration of com9 ments to a public docket on such proposal, and 

10 publication of a final action on such website 

11 within 60 calendar days of the close of the com12 ment period posted to such public docket, not13 withstanding subchapter II of chapter 5 of title 

14 5, United States Code. 

15 ‘‘(B) PROCESS FOR FIRST-OF-A-KIND

16 TEST.—In the case of an in vitro clinical test 

17 that is first-of-a-kind, the process is as follows: 

18 ‘‘(i) Any determination that the test is 

19 subject to premarket approval or abbre20 viated premarket review under subpara21 graph (A) or (B) of paragraph (1) shall be 

22 published on the website of the Food and 

23 Drug Administration, notwithstanding sub24 clause II of chapter 5 of title 5, United 

25 States Code, only after the in vitro clinical 


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1 test is approved under section 587B. Until 

2 that time, the determination shall not be 

3 binding on other in vitro clinical tests. 

4 ‘‘(ii) Any determination other than 

5 those made under clause (i) shall be made 

6 by publication of a notice of final action on 

7 the website of the Food and Drug Admin8 istration, notwithstanding subchapter II of 

9 chapter 5 of title 5, United States Code. 

10 ‘‘(5) NO EFFECT ON GRANDFATHERING DETER11 MINATIONS.—A determination under paragraph (1) 

12 shall have no effect on the applicability of section 

13 587G to an in vitro clinical tests. 

14 ‘‘(b) TRANSITION PERIOD.—Upon a decision by the 

15 Secretary to change a regulatory pathway designation, or 

16 reclassifies an in vitro clinical test, or category of in vitro 

17 clinical tests, the Secretary shall provide an appropriate 

18 transition period with respect to any new requirements. 

19 ‘‘(c) APPEALS.—A decision by the Secretary under 

20 this section shall be deemed a significant decision subject 

21 to appeal under section 587P. 

22 ‘‘(d) ADVISORY COMMITTEE.—The Secretary may re23 quest recommendations from an advisory committee under 

24 section 587H pursuant to carrying out this section. 


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1 ‘‘(e) REQUEST FOR INFORMAL FEEDBACK.—Before 

2 submitting a premarket application or technology certifi3 cation application for an in vitro clinical test— 

4 ‘‘(1) the developer of the test may submit to the 

5 Secretary a written request for a meeting, con6 ference, or written feedback to discuss and provide 

7 information relating to the regulation of such in 

8 vitro clinical test which may include— 

9 ‘‘(A) the submission process and the type 

10 and amount of evidence expected to dem11 onstrate the applicable standard; 

12 ‘‘(B) which regulatory pathway is appro13 priate for an in vitro clinical test; and 

14 ‘‘(C) an investigation plan for an in vitro 

15 clinical test, including a clinical protocol; and 

16 ‘‘(2) upon receipt of such a request, the Sec17 retary shall— 

18 ‘‘(A) if a meeting is requested— 

19 ‘‘(i) within 60 calendar days after 

20 such receipt, or within such time period as 

21 may be agreed to by the developer, meet or 

22 confer with the developer submitting the 

23 request; and 

24 ‘‘(ii) within 15 calendar days after 

25 such meeting or conference, provide to the 


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1 developer a written record or response de2 scribing the issues discussed and conclu3 sions reached in the meeting or conference; 

4 and 

5 ‘‘(B) if written feedback is requested, pro6 vide feedback to the requestor within 75 days 

7 after such receipt. 

8 ‘‘SEC. 587G. GRANDFATHERED IN VITRO CLINICAL TESTS. 

9 ‘‘(a) IN GENERAL.—Subject to subsection (d), an in 

10 vitro clinical test is exempt from the requirements of this 

11 subchapter specified in subsection (b) if— 

12 ‘‘(1) the test was first offered for clinical use, 

13 and was not intended solely for investigational use, 

14 not later than 45 days after the date of enactment 

15 of the VALID Act of 2023; 

16 ‘‘(2) the test was developed by a clinical labora17 tory for which a certificate was in effect under sec18 tion 353 of the Public Health Service Act that meets 

19 the requirements for performing tests of high com20 plexity; 

21 ‘‘(3) the test is performed— 

22 ‘‘(A) in the same clinical laboratory in 

23 which the test was developed for which a certifi24 cation is still in effect under section 353 of the 


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1 Public Health Service Act that meets the re2 quirements to perform tests of high complexity; 

3 ‘‘(B) by another clinical laboratory for 

4 which a certificate is in effect under section 353 

5 of such Act that meets the requirements to per6 form tests of high complexity, and that is with7 in the same corporate organization and having 

8 common ownership by the same parent corpora9 tion as the laboratory in which the test was de10 veloped; or 

11 ‘‘(C) in the case of a test that was devel12 oped by the Centers for Disease Control and 

13 Prevention or another laboratory in a public 

14 health laboratory network coordinated or man15 aged by the Centers for Disease Control and 

16 Prevention, by a clinical laboratory for which a 

17 certificate is in effect under section 353 of such 

18 Act that meets the requirements to perform 

19 tests of high complexity, and that is within a 

20 public health laboratory network coordinated or 

21 managed by the Centers for Disease Control 

22 and Prevention; 

23 ‘‘(4) the test does not have in effect an ap24 proval under section 515, a clearance under section 

25 510(k), an authorization under section 513(f)(2), or 


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1 an exemption under section 520(m), or licensure 

2 under section 351 of the Public Health Service Act; 

3 ‘‘(5) any modification to the test on or after the 

4 date that is 45 days after the date of enactment of 

5 the VALID Act of 2023 is made by the initial devel6 oper, conforms with section 587C(a)(6)(A)(ii), and 

7 does not meet the criteria in subsection (d)(1); 

8 ‘‘(6) when used as an investigational in vitro 

9 clinical test, such test complies with section 587S, as 

10 applicable; 

11 ‘‘(7) the test is offered with an order from an 

12 authorized person as required under section 353 of 

13 the Public Health Service Act, and was offered with 

14 a prescription required under section 809.30(f) of 

15 title 21, Code of Federal Regulations prior to the ef16 fective date of this subchapter; 

17 ‘‘(8) the test is not for use with home specimen 

18 collection, unless the specimen is collected with a 

19 collection container, receptacle, or kit that— 

20 ‘‘(A) has been approved, cleared, or au21 thorized by the Secretary for home specimen 

22 collection and the collection is performed pursu23 ant to the approved, cleared, or authorized la24 beling, including any indication for use as pre25 scription use or over-the-counter use, or 


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1 ‘‘(B) is exempt from premarket review and 

2 its use is consistent with applicable limitations 

3 on the exemption; 

4 ‘‘(9) the test is not a specimen receptacle or in5 strument; 

6 ‘‘(10) each test report for the test bears a 

7 statement that reads as follows: ‘This in vitro clin8 ical test was introduced into commerce prior to the 

9 application of the VALID Act and is exempt from 

10 FDA premarket review.’; and 

11 ‘‘(11) the developer of the test— 

12 ‘‘(A) maintains documentation dem13 onstrating that the test meets and continues to 

14 meet the criteria set forth in this subsection; 

15 and 

16 ‘‘(B) makes such documentation available 

17 to the Secretary upon request. 

18 ‘‘(b) EXEMPTIONS APPLICABLE TO GRAND19 FATHERED TESTS.—An in vitro clinical test that meets 

20 the criteria specified in subsection (a) is exempt from pre21 market review under 587B, labeling requirements under 

22 587L, and test design requirements and quality require23 ments under 587K, and may be lawfully offered subject 

24 to the other applicable requirements of this Act. 


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1 ‘‘(c) MODIFICATIONS.—In the case of an in vitro clin2 ical test that meets the criteria specified in subsection (a), 

3 such test continues to qualify for the exemptions described 

4 in subsection (b) if the test is modified and the modifica5 tion is of a type described in subsection (a)(5), and the 

6 person modifying such in vitro clinical test— 

7 ‘‘(1) documents each such modification and 

8 maintains documentation of the basis for such deter9 mination; 

10 ‘‘(2) provides such documentation relating to 

11 the change to the Secretary upon request or inspec12 tion; and 

13 ‘‘(3) does not modify the in vitro clinical test 

14 such that it no longer meets the criteria under sub15 section (a). 

16 ‘‘(d) REQUEST FOR INFORMATION.— 

17 ‘‘(1) CRITERIA.—The criteria described in this 

18 paragraph are any of the following: 

19 ‘‘(A) There is a lack of valid scientific evi20 dence to support that the in vitro clinical test 

21 is analytically valid or clinically valid. 

22 ‘‘(B) Such in vitro clinical test is being of23 fered by its developer with any false or mis24 leading analytical or clinical claims. 


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1 ‘‘(C) It is probable that such in vitro clin2 ical test will cause serious adverse health con3 sequences. 

4 ‘‘(2) PROCESS.— 

5 ‘‘(A) WRITTEN REQUEST FOR INFORMA6 TION.—The Secretary may issue a written re7 quest to a developer identifying specific sci8 entific concerns, based on credible information, 

9 with an in vitro clinical test, which indicate that 

10 one or more of the criteria described in para11 graph (1) apply to such in vitro clinical test. 

12 Such written request shall include specific infor13 mation requests pertaining to such criteria. 

14 ‘‘(B) DEADLINE FOR SUBMITTING INFOR15 MATION.—Not later than 45 days after receiv16 ing a request for information under subpara17 graph (A)— 

18 ‘‘(i) the developer of an in vitro clin19 ical test— 

20 ‘‘(I) may seek a teleconference 

21 prior to the submission of information 

22 under subclause (II) to discuss the 

23 Secretary’s request; and 

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1 graph (A), and may include in such 

2 submission a request for a teleconfer3 ence; and 

4 ‘‘(ii) the Secretary shall— 

5 ‘‘(I) schedule a teleconference re6 quested under clause (i)(I); and 

7 ‘‘(II) hold a teleconference if re8 quested within 10 days of the Sec9 retary’s receipt of the information 

10 submitted under clause (i)(II). 

11 ‘‘(C) REVIEW DEADLINE.—Upon receiving 

12 a submission under subparagraph (B), the Sec13 retary shall— 

14 ‘‘(i) review the submitted information 

15 within 45 calendar days of such receipt, 

16 which may include communication with the 

17 developer; and 

18 ‘‘(ii) determine whether the criteria 

19 listed in paragraph (1) apply to the in 

20 vitro clinical test and communicate such 

21 determination to the developer as described 

22 in subparagraph (D). 

23 ‘‘(D) COMMUNICATION AND RESULTS OF

24 DETERMINATION.—The Secretary shall notify 


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1 the developer, in writing, of the Secretary’s de2 termination under subparagraph (C), as follows: 

3 ‘‘(i) If the Secretary determines that 

4 none of the criteria listed in paragraph (1) 

5 apply to the in vitro clinical test, such test 

6 shall be exempt from relevant requirements 

7 of this subchapter, as set forth in sub8 section (b), subject to the criteria under 

9 subsection (a). 

10 ‘‘(ii) If the Secretary determines that 

11 one or more of the criteria listed in para12 graph (1) apply to the test but such a de13 termination may be resolved within a rea14 sonable time, and the test has not been 

15 previously subject to this subsection on the 

16 basis of the same or substantially similar 

17 scientific concerns identified in the written 

18 request issued under paragraph 

19 (d)(2)(A)— 

20 ‘‘(I) the Secretary shall notify the 

21 developer of such a determination and 

22 allow the developer to seek a tele23 conference to discuss the finding; 

24 ‘‘(II) the developer shall submit 

25 information demonstrating resolution 


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1 of the determination within 15 days of 

2 receiving such notification; and 

3 ‘‘(III) the Secretary shall make a 

4 determination within 30 days of the 

5 receipt of such submission of informa6 tion as to whether the criteria under 

7 paragraph (1) continue to apply to the 

8 test and, if through such determina9 tion the Secretary determines that— 

10 ‘‘(aa) none of the criteria 

11 listed in paragraph (1) apply to 

12 the test, such test shall be ex13 empt from relevant requirements 

14 of the subchapter as set forth in 

15 subsection (b), subject to applica16 ble limitations; or 

17 ‘‘(bb) one or more of the cri18 teria listed in paragraph (1) 

19 apply to the in vitro clinical test, 

20 such test is not exempt as set 

21 forth in this section and shall not 

22 be offered unless approved under 

23 section 587B, or, upon a deter24 mination by the Secretary pursu25 ant to section 587F, offered 


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1 under a technology certification 

2 order under section 587D or of3 fered as a low-risk test. 

4 ‘‘(iii) If the Secretary determines that 

5 one or more of the criteria listed in para6 graph (1) apply to the in vitro clinical test 

7 and clause (ii) does not apply, the in vitro 

8 clinical test is not exempt as set forth in 

9 this section and shall not be offered unless 

10 approved under section 587B, or upon a 

11 determination by the Secretary pursuant to 

12 section 587F, offered under a technology 

13 certification order under section 587D or 

14 offered as a low-risk test. 

15 ‘‘SEC. 587H. ADVISORY COMMITTEES. 

16 ‘‘(a) IN GENERAL.—The Secretary may establish ad17 visory committees or use advisory committee panels of ex18 perts established before the date of enactment of the 

19 VALID Act of 2023 (including a device classification 

20 panel under section 513) for the purposes of providing ex21 pert scientific advice and making recommendations related 

22 to— 

23 ‘‘(1) the approval of an application for an in 

24 vitro clinical test submitted under this subchapter, 

25 including for evaluating, as applicable, the analytical 


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1 validity, clinical validity, and safety of in vitro clin2 ical tests; 

3 ‘‘(2) the potential effectiveness of mitigating 

4 measures for a determination of the applicable regu5 latory pathway under section 587F(b) or risk eval6 uation for an in vitro clinical test or tests; 

7 ‘‘(3) quality requirements under section 587K 

8 or applying such requirements to in vitro clinical 

9 tests developed or imported by developers; 

10 ‘‘(4) appeals under section 587P; or 

11 ‘‘(5) such other purposes as the Secretary de12 termines appropriate. 

13 ‘‘(b) APPOINTMENTS.— 

14 ‘‘(1) VOTING MEMBERS.—The Secretary shall 

15 appoint to each committee established under sub16 section (a), as voting members, individuals who are 

17 qualified by training and experience to evaluate in 

18 vitro clinical tests referred to the committee for the 

19 purposes specified in subsection (a), including indi20 viduals with, to the extent feasible, scientific exper21 tise in the development of such in vitro clinical tests, 

22 laboratory operations, and the use of in vitro clinical 

23 tests. The Secretary shall designate one member of 

24 each committee to serve as chair. 


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1 ‘‘(2) NONVOTING MEMBERS.—In addition to the 

2 individuals appointed pursuant to paragraph (1), the 

3 Secretary shall appoint to each committee estab4 lished under subsection (a), as nonvoting members— 

5 ‘‘(A) a representative of consumer inter6 ests; and 

7 ‘‘(B) a representative of interests of in 

8 vitro clinical test developers not directly af9 fected by the matter to be brought before the 

10 committee. 

11 ‘‘(3) LIMITATION.—No individual who is a reg12 ular full-time employee of the United States and en13 gaged in the administration of this Act may be a 

14 member of any advisory committee established under 

15 subsection (a). 

16 ‘‘(4) EDUCATION AND TRAINING.—The Sec17 retary shall, as appropriate, provide education and 

18 training to each new committee member before such 

19 member participates in a committee’s activities, in20 cluding education regarding requirements under this 

21 Act and related regulations of the Secretary, and the 

22 administrative processes and procedures related to 

23 committee meetings. 

24 ‘‘(5) MEETINGS.—The Secretary shall ensure 

25 that scientific advisory committees meet regularly 


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1 and at appropriate intervals so that any matter to 

2 be reviewed by such a committee can be presented 

3 to the committee not more than 60 calendar days 

4 after the matter is ready for such review. Meetings 

5 of the committee may be held using electronic or tel6 ephonic communication to convene the meetings. 

7 ‘‘(6) COMPENSATION.—Members of an advisory 

8 committee established under subsection (a), while at9 tending meetings or conferences or otherwise en10 gaged in the business of the advisory committee— 

11 ‘‘(A) shall be entitled to receive compensa12 tion at rates to be fixed by the Secretary, but 

13 not to exceed the daily equivalent of the rate in 

14 effect for positions classified above level GS–15 

15 of the General Schedule; and 

16 ‘‘(B) may be allowed travel expenses as au17 thorized by section 5703 of title 5, United 

18 States Code, for employees serving intermit19 tently in the Government service. 

20 ‘‘(c) GUIDANCE.—The Secretary may issue guidance 

21 on the policies and procedures governing advisory commit22 tees established under subsection (a). 

23 ‘‘SEC. 587I. BREAKTHROUGH IN VITRO CLINICAL TESTS. 

24 ‘‘(a) IN GENERAL.—The purpose of this section is 

25 to encourage the Secretary, and provide the Secretary with 


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1 sufficient authority, to apply efficient and flexible ap2 proaches to expedite the development of, and prioritize the 

3 review of, in vitro clinical tests that represent break4 through technologies. 

5 ‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 

6 shall establish a program to expedite the development of, 

7 and provide for the priority review of, in vitro clinical 

8 tests. 

9 ‘‘(c) ELIGIBILITY.—The program developed under 

10 subsection (b) shall be available for any in vitro clinical 

11 test that— 

12 ‘‘(1) provides or enables more effective treat13 ment or diagnosis of life-threatening or irreversibly 

14 debilitating human disease or conditions; and 

15 ‘‘(2) is a test— 

16 ‘‘(A) that represents a breakthrough tech17 nology; 

18 ‘‘(B) for which no approved alternative in 

19 vitro clinical test exists, including no in vitro 

20 clinical test offered under a technology certifi21 cation order; 

22 ‘‘(C) that offers a clinically meaningful ad23 vantage over existing alternative in vitro clinical 

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1 cation order), including the potential to reduce 

2 or eliminate the need for hospitalization, im3 prove patient quality of life, facilitate patients’ 

4 ability to manage their own care (such as 

5 through self-directed personal assistance), or es6 tablish long-term clinical efficiencies; or 

7 ‘‘(D) the availability of which is in the best 

8 interest of patients or public health. 

9 ‘‘(d) DESIGNATION.— 

10 ‘‘(1) REQUEST.—To receive breakthrough des11 ignation under this section, an applicant may re12 quest that the Secretary designate the in vitro clin13 ical test for expedited development and priority re14 view. Any such request for designation may be made 

15 at any time prior to, or at the time of, the submis16 sion of an application under section 587B or 587D, 

17 and shall include information demonstrating that the 

18 test meets the criteria described in subsection (c). 

19 ‘‘(2) DETERMINATION.—Not later than 60 cal20 endar days after the receipt of a request under para21 graph (1), the Secretary shall determine whether the 

22 in vitro clinical test that is the subject of the request 

23 meets the criteria described in subsection (c). If the 

24 Secretary determines that the test meets the criteria, 


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1 the Secretary shall designate the test for expedited 

2 development and priority review. 

3 ‘‘(3) REVIEW.—Review of a request under para4 graph (1) shall be undertaken by a team that is 

5 composed of experienced staff and senior managers 

6 of the Food and Drug Administration. 

7 ‘‘(4) WITHDRAWAL.— 

8 ‘‘(A) IN GENERAL.—The designation of an 

9 in vitro clinical test under this subsection is 

10 deemed to be withdrawn, and such in vitro clin11 ical test shall no longer be eligible for designa12 tion under this section, if an application for ap13 proval for such test under section 587B or 

14 587D is denied. Such test shall be eligible for 

15 breakthrough designation upon a new request 

16 for such designation. 

17 ‘‘(B) EXCEPTION.—The Secretary may not 

18 withdraw a designation granted under this sub19 section based on the subsequent approval or 

20 technology certification of another in vitro clin21 ical test that— 

22 ‘‘(i) is designated under this section; 

23 or 

24 ‘‘(ii) was given priority review under 

25 section 515B. 


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1 ‘‘(e) ACTIONS.—For purposes of expediting the devel2 opment and review of in vitro clinical tests under this sec3 tion, the Secretary may take the actions and additional 

4 actions set forth in paragraphs (1) and (2), respectively, 

5 of section 515B(e) when reviewing such tests. Any ref6 erence or authorization in section 515B(e) with respect 

7 to a device shall be deemed a reference or authorization 

8 with respect to an in vitro clinical test for purposes of this 

9 section. 

10 ‘‘(f) GUIDANCE.—Not later than 30 months after the 

11 date of enactment of the VALID Act of 2023, the Sec12 retary shall issue final guidance on the implementation of 

13 this section. Such guidance shall— 

14 ‘‘(1) set forth the process by which a person 

15 may seek a designation under subsection (d); 

16 ‘‘(2) provide a template for request under sub17 section (d); 

18 ‘‘(3) identify the criteria the Secretary will use 

19 in evaluating a request for designation; and 

20 ‘‘(4) identify the criteria and processes the Sec21 retary will use to assign a team of staff, including 

22 team leaders, to review in vitro clinical tests des23 ignated for expedited development and priority re24 view, including any training required for such per25 sonnel to ensure effective and efficient review. 


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1 ‘‘(g) RULES OF CONSTRUCTION.—Nothing in this 

2 section shall be construed to affect— 

3 ‘‘(1) the criteria and standards for evaluating 

4 an application pursuant to section 587B or 587D, 

5 including the recognition of valid scientific evidence 

6 as described in section 587(20) and consideration 

7 and application of the least burdensome means de8 scribed under section 587AA(c); 

9 ‘‘(2) the authority of the Secretary with respect 

10 to clinical holds under section 587S; 

11 ‘‘(3) the authority of the Secretary to act on an 

12 application pursuant to section 587B before comple13 tion of an establishment inspection, as the Secretary 

14 determines appropriate; or 

15 ‘‘(4) the authority of the Secretary with respect 

16 to postmarket surveillance under section 587X. 

17 ‘‘SEC. 587J. REGISTRATION AND LISTING. 

18 ‘‘(a) REGISTRATION REQUIREMENT.— 

19 ‘‘(1) IN GENERAL.—Each person described in 

20 subsection (b)(1) shall— 

21 ‘‘(A) during the period beginning on Octo22 ber 1 and ending on December 31 of each year, 

23 register with the Secretary the name of such 

24 person, places of business of such person, all es25 tablishments engaged in the activities specified 


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1 under this paragraph, the establishment reg2 istration number of each such establishment, 

3 and a point of contact for each such establish4 ment, including an electronic point of contact; 

5 and 

6 ‘‘(B) submit an initial registration con7 taining the information required under subpara8 graph (A)— 

9 ‘‘(i) in accordance with the timelines 

10 for submission under subsection (c), if the 

11 establishment is engaged in any activity 

12 described in subsection (b)(1) on the effec13 tive date of this section, unless the Sec14 retary establishes by guidance a date later 

15 than such date for all or a category of such 

16 establishments; or 

17 ‘‘(ii) not later than 30 days prior to 

18 engaging in any activity described in sub19 section (b)(1), if the establishment is not 

20 engaged in any activity described in this 

21 paragraph on the effective date of this sec22 tion. 

23 ‘‘(2) REGISTRATION NUMBERS.—The Secretary 

24 may assign a registration number to any person or 

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1 lishment registered in accordance with this section. 

2 Registration information shall be made publicly 

3 available by publication on the website maintained 

4 by the Food and Drug Administration, in accord5 ance with subsection (d). 

6 ‘‘(3) INSPECTION.—Each person or establish7 ment that is required to be registered with the Sec8 retary under this section shall be subject to inspec9 tion pursuant to section 704. 

10 ‘‘(b) LISTING INFORMATION FOR IN VITRO CLINICAL

11 TESTS.— 

12 ‘‘(1) IN GENERAL.—Each person who— 

13 ‘‘(A) is a developer; and 

14 ‘‘(B) introduces or proposes to begin the 

15 introduction or delivery for introduction into 

16 interstate commerce through an exemption 

17 under subsection (a)(1), (a)(2), (a)(3), or (g) of 

18 section 587C or section 587G or through the 

19 filing of an application under section 587B or 

20 section 587D, 

21 shall submit a listing to the Secretary containing the 

22 information described in paragraph (2), or (4), as 

23 applicable, in accordance with the applicable sched24 ule described under subsection (c). Such listing shall 

25 be prepared in such form and manner as the SecVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00121 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 retary may specify in guidance. Listing information 

2 shall be submitted through the comprehensive test 

3 information system in accordance with section 587T, 

4 as appropriate. 

5 ‘‘(2) SUBMISSIONS.—Each developer submitting 

6 a listing under paragraph (1) shall electronically 

7 submit to the comprehensive test information system 

8 described in section 587T the following information, 

9 as applicable, for each in vitro clinical test for which 

10 such person is a developer in the form and manner 

11 prescribed by the Secretary, taking into account the 

12 least burdensome requirements under section 

13 587AA(c): 

14 ‘‘(A) Name of the establishment and its es15 tablishment registration number. 

16 ‘‘(B) Contact information for the official 

17 correspondent for the listing. 

18 ‘‘(C) Name (common name and trade 

19 name, if applicable) of the in vitro clinical test 

20 and its test listing number (when available). 

21 ‘‘(D) The certificate number for any lab22 oratory certified by the Secretary under section 

23 353 of the Public Health Service Act that 

24 meets the requirements to perform high-com25 plexity testing and that is the developer of the 


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1 in vitro clinical test, and the certificate number 

2 under such section for any laboratory that is 

3 performing the test, is within the same cor4 porate organization, and has common ownership 

5 by the same parent corporation. 

6 ‘‘(E) Whether the in vitro clinical test is, 

7 as applicable, offered as a test approved under 

8 section 587B, offered under a granted tech9 nology certification order, or offered as an ex10 empt in vitro clinical test under section 587C or 

11 587G. 

12 ‘‘(F) Indications for use information under 

13 section 587(10). 

14 ‘‘(G) A brief summary of the analytical 

15 and clinical performance of the in vitro clinical 

16 test, and as applicable, the lot release criteria. 

17 ‘‘(H) A brief description of conformance 

18 with any applicable mitigating measures, re19 strictions, and standards. 

20 ‘‘(I) Representative labeling for the in vitro 

21 clinical test, as appropriate. 

22 ‘‘(3) TEST LISTING NUMBER.—The Secretary 

23 may assign a test listing number to each in vitro 

24 clinical test that is the subject of a listing under this 

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1 bers may be established through guidance, and may 

2 include the recognition of standards, formats, or 

3 conventions developed by a third-party organization. 

4 ‘‘(4) GRANDFATHERED TESTS.—A developer of5 fering a test that is a grandfathered in vitro clinical 

6 test under section 587G(a) shall submit listing infor7 mation required under subparagraphs (A) through 

8 (F) of paragraph (2), and may submit a statement 

9 of the performance specifications for such in vitro 

10 clinical tests. 

11 ‘‘(5) EXEMPT TESTS.—A developer of an in 

12 vitro clinical test who introduces or proposes to 

13 begin the introduction or delivery for introduction 

14 into interstate commerce that is otherwise exempt 

15 from the requirement to submit listing information 

16 pursuant to an exemption under section 587C may 

17 submit listing information under this subsection. 

18 ‘‘(c) TIMELINES FOR SUBMISSION OF LISTING IN19 FORMATION.— 

20 ‘‘(1) IN GENERAL.—The timelines for submis21 sion of registration and listing under subsections (a) 

22 and (b) are as follows: 

23 ‘‘(A) For an in vitro clinical test that was 

24 listed as a device under section 510(j) prior to 

25 the effective date of this section, a person shall 


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1 maintain a device listing under section 510 

2 until such time as the system for submitting 

3 the listing information required under sub4 section (b) becomes available and thereafter 

5 shall submit the listing information not later 

6 than the later of 1 year after the system for 

7 submitting the listing under this section be8 comes available or the effective date of this sec9 tion. 

10 ‘‘(B) For an in vitro clinical test that is 

11 subject to grandfathering under section 

12 587G(a) a person shall submit the listing infor13 mation required under subsection (b)(4) within 

14 10 calendar days of offering the test after the 

15 effective date of this section. 

16 ‘‘(C) For an in vitro clinical test that is 

17 not described in subparagraph (A) or (B), a 

18 person shall submit the required listing infor19 mation as follows: 

20 ‘‘(i) For an in vitro clinical test that 

21 is not exempt from premarket approval 

22 under section 587B, a person shall submit 

23 the required listing information, prior to 

24 offering the in vitro clinical test and not 

25 later than 30 business days after the date 


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1 of approval of the premarket approval ap2 plication. 

3 ‘‘(ii) For an in vitro clinical test that 

4 is exempt from premarket review under 

5 section 587C, the required listing informa6 tion shall be submitted prior to offering 

7 the in vitro clinical test. 

8 ‘‘(2) UPDATES.— 

9 ‘‘(A) UPDATES AFTER CHANGES.—Each 

10 developer required to submit listing information 

11 under this section shall update such informa12 tion within 10 business days of any change that 

13 causes any previously listed information to be 

14 inaccurate or incomplete. 

15 ‘‘(B) ANNUAL UPDATES.—Each developer 

16 required to submit listing information under 

17 this section shall update its information annu18 ally during the period beginning on October 1 

19 and ending on December 31 of each year. 

20 ‘‘(d) PUBLIC AVAILABILITY OF LISTING INFORMA21 TION.— 

22 ‘‘(1) IN GENERAL.—Listing information sub23 mitted pursuant to this section shall be made pub24 licly available on the website of the Food and Drug 

25 Administration in accordance with paragraph (3). 


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1 ‘‘(2) CONFIDENTIALITY.—Listing information 

2 for an in vitro clinical test that is subject to pre3 market approval or technology certification shall re4 main confidential until such date as the in vitro clin5 ical test receives the applicable premarket approval 

6 or the developer receives a technology certification 

7 order and for subsequent tests introduced under a 

8 technology certification order until their introduc9 tion. 

10 ‘‘(3) EXCEPTIONS FROM PUBLIC AVAILABILITY

11 REQUIREMENTS.—The public listing requirements of 

12 this subsection shall not apply to any registration 

13 and listing information submitted under subsection 

14 (a) or (b), if the Secretary determines that such in15 formation— 

16 ‘‘(A) is a trade secret or confidential com17 mercial or financial information; or 

18 ‘‘(B) if posted, could compromise national 

19 security. 

20 ‘‘(e) SUBMISSION OF INFORMATION BY ACCREDITED

21 PERSONS.—If agreed upon by the developer, the informa22 tion required under this section may be submitted by a 

23 person accredited under section 587Q. 

24 ‘‘SEC. 587K. TEST DESIGN AND QUALITY REQUIREMENTS. 

25 ‘‘(a) APPLICABILITY.— 


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1 ‘‘(1) IN GENERAL.—Each developer shall estab2 lish and maintain quality requirements in accord3 ance with the applicable requirements set forth in 

4 subsection (b). 

5 ‘‘(2) CERTIFIED LABORATORY REQUIRE6 MENTS.—A developer shall establish and maintain 

7 quality requirement under subsection (b)(2) or 

8 (b)(3), as applicable, if such developer is a clinical 

9 laboratory certified by the Secretary under section 

10 353 of the Public Health Service Act that— 

11 ‘‘(A) is certified to perform high-com12 plexity testing; 

13 ‘‘(B) develops an in vitro clinical test that 

14 is for use only— 

15 ‘‘(i) within the laboratory certified by 

16 the Secretary under such section 353 in 

17 which such test was developed; or 

18 ‘‘(ii) within another laboratory cer19 tified by the Secretary under such section 

20 353 if such laboratory is— 

21 ‘‘(I) within the same corporate 

22 organization and has common owner23 ship by the same parent corporation 

24 as the laboratory in which the test 

25 was developed; or 


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1 ‘‘(II) within a public health lab2 oratory network coordinated or man3 aged by the Centers for Disease Con4 trol and Prevention, if the test is de5 veloped by a public health laboratory 

6 or the Centers for Disease Control 

7 and Prevention; and 

8 ‘‘(C) does not manufacture, produce, or 

9 distribute in vitro clinical tests other than lab10 oratory test protocols. 

11 ‘‘(3) REGULATIONS.—The Secretary shall pro12 mulgate quality system regulations implementing 

13 this section. In promulgating such regulations under 

14 this section, the Secretary shall consider whether, 

15 and to what extent, international harmonization is 

16 appropriate. 

17 ‘‘(4) QUALITY SYSTEMS FOR HYBRID DEVEL18 OPERS OF BOTH LABORATORY TEST PROTOCOLS AND

19 OTHER IN VITRO CLINICAL TESTS.—An entity that 

20 develops both laboratory test protocols and other in 

21 vitro clinical tests shall comply with subsection 

22 (b)(1) for activities related to the development of 

23 any in vitro clinical test that is not a laboratory test 

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1 plicable, for activities related to the development of 

2 any laboratory test protocol. 

3 ‘‘(b) QUALITY REQUIREMENTS.— 

4 ‘‘(1) IN GENERAL.—The quality requirements 

5 applicable under this section shall— 

6 ‘‘(A) avoid duplication of regulations and 

7 guidance under section 353 of the Public 

8 Health Service Act, such that laboratories 

9 would not be subject to conflicting regulatory 

10 obligations with respect to the same activity; 

11 ‘‘(B) not apply to laboratory operations; 

12 and 

13 ‘‘(C) include, as applicable, subject to sub14 paragraphs (A) and (B) and paragraphs (2) 

15 and (3)— 

16 ‘‘(i) management responsibilities; 

17 ‘‘(ii) quality audits; 

18 ‘‘(iii) personnel; 

19 ‘‘(iv) design controls; 

20 ‘‘(v) document controls; 

21 ‘‘(vi) purchasing controls; 

22 ‘‘(vii) identification and traceability; 

23 ‘‘(viii) production and process con24 trols; 

25 ‘‘(ix) acceptance activities; 


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1 ‘‘(x) nonconforming in vitro clinical 

2 tests; 

3 ‘‘(xi) corrective and preventive action; 

4 ‘‘(xii) labeling and packaging controls; 

5 ‘‘(xiii) handling, storage, distribution, 

6 and installation; 

7 ‘‘(xiv) complaints and records; 

8 ‘‘(xv) servicing; and 

9 ‘‘(xvi) statistical techniques. 

10 ‘‘(2) EXCEPTION FOR LABORATORY TEST PRO11 TOCOLS.—Developers that are developing test proto12 cols for use as described in subsection (a)(2)(B)(i) 

13 are exempt from the requirements under paragraph 

14 (1)(C) except for the requirements described in 

15 clauses (iv), (ix), (xi), and (xiv) of such paragraph. 

16 ‘‘(3) QUALITY REQUIREMENTS FOR CERTAIN

17 LABORATORIES DISTRIBUTING LABORATORY TEST

18 PROTOCOLS WITHIN ORGANIZATIONS OR PUBLIC

19 HEALTH NETWORKS.—Quality requirements applica20 ble to the developer who is distributing a laboratory 

21 test protocol as described in subsection (a)(2)(B)(ii) 

22 shall consist of the following: 

23 ‘‘(A) Clauses (iv), (ix), (xi), (xiv), (xii) of 

24 paragraph (1)(B). 


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1 ‘‘(B) The requirement to maintain records 

2 of the laboratories to which the laboratory test 

3 protocol is distributed. 

4 ‘‘(c) REGULATIONS.—In implementing quality re5 quirements for test developers that participate in inter6 national audit programs under this section, the Secretary 

7 shall— 

8 ‘‘(1) for purposes of facilitating international 

9 harmonization, consider whether the developer par10 ticipates in an international audit program in which 

11 the United States participates and recognizes com12 pliance with, or conformance to, such standards rec13 ognized by the Secretary; and 

14 ‘‘(2) ensure a least burdensome approach de15 scribed in section 587AA(c) by leveraging, to the ex16 tent applicable, the quality assurance requirements 

17 applicable to developers certified by the Secretary 

18 under section 353 of the Public Health Service Act. 

19 ‘‘SEC. 587L. LABELING REQUIREMENTS. 

20 ‘‘(a) IN GENERAL.—An in vitro clinical test shall 

21 bear or be accompanied by labeling, as applicable, that 

22 meets the requirements set forth in subsections (b) and 

23 (c), unless such test is exempt under subsection (d) or (e). 

24 ‘‘(b) LABELS.— 


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1 ‘‘(1) IN GENERAL.—The label of an in vitro 

2 clinical test, shall meet the requirements set forth in 

3 paragraph (2) if there is an immediate container to 

4 which the label is applied. 

5 ‘‘(2) REGULATIONS.—The label of an in vitro 

6 clinical test shall state the name and place of busi7 ness of its developer and meet the requirements set 

8 forth in regulations promulgated in accordance with 

9 this section. 

10 ‘‘(c) LABELING.— 

11 ‘‘(1) IN GENERAL.—Labeling of an in vitro clin12 ical test, including labeling in the form of a package 

13 insert, website, standalone laboratory reference docu14 ment, or other similar document shall include— 

15 ‘‘(A) adequate directions for use and shall 

16 meet the requirements set forth in regulations 

17 promulgated under this section, except as pro18 vided in subsection (d) or (e); and 

19 ‘‘(B) the information described in para20 graph (2), as applicable. 

21 ‘‘(2) CONTENT.—Labeling of an in vitro clinical 

22 test shall include— 

23 ‘‘(A) the test listing number that was pro24 vided to the developer at the time of listing; 


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1 ‘‘(B) information to facilitate reporting an 

2 adverse event; 

3 ‘‘(C) information regarding accessing the 

4 performance summary data displayed in the 

5 listing database for the test; 

6 ‘‘(D) the indications for use of the in vitro 

7 clinical test; and 

8 ‘‘(E) any warnings, contraindications, or 

9 limitations. 

10 ‘‘(3) PUBLIC AVAILABILITY OF INFORMATION.— 

11 The Secretary shall make all of the information de12 scribed in paragraph (2) with respect to each in 

13 vitro clinical test available to the public, as applica14 ble, in accordance with section 587T, except to the 

15 extent that the Secretary determines that such infor16 mation— 

17 ‘‘(A) is trade secret or confidential com18 mercial or financial information; or 

19 ‘‘(B) if posted, could compromise national 

20 security. 

21 ‘‘(4) ADDITIONAL REQUIREMENTS.—Labeling 

22 for an in vitro clinical test used for 

23 immunohematology testing shall meet the applicable 

24 requirements set forth in part 660 of title 21, Code 

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1 tions), related to the labeling of blood grouping re2 agents, reagent red blood cells, and anti-human 

3 globulin. 

4 ‘‘(d) EXEMPTIONS AND ALTERNATIVE REQUIRE5 MENTS.— 

6 ‘‘(1) IN GENERAL.— 

7 ‘‘(A) IN GENERAL.—With respect to an in 

8 vitro clinical test that meets the criteria of sub9 paragraph (B), the ‘state in one place’ regula10 tions under section 809.10(b) of title 21, Code 

11 of Federal Regulations (or any successor regu12 lations) may be satisfied by the laboratory post13 ing such information on its website or in mul14 tiple documents, if such documents are main15 tained and accessible in one place. 

16 ‘‘(B) APPLICABLE TESTS.—An in vitro 

17 clinical test meets the criteria of this subpara18 graph if such test is— 

19 ‘‘(i) developed by a laboratory cer20 tified by the Secretary under section 353 

21 of the Public Health Service Act that 

22 meets the requirements to perform tests of 

23 high-complexity; and 

24 ‘‘(ii) performed in— 


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1 ‘‘(I) the same laboratory in which 

2 such test was developed; or 

3 ‘‘(II) by another laboratory cer4 tified by the Secretary under section 

5 353 of the Public Health Service Act 

6 that— 

7 ‘‘(aa) meets the require8 ments to perform tests of high 

9 complexity; and 

10 ‘‘(bb) is under common own11 ership and control as the labora12 tory that developed the test. 

13 ‘‘(2) TEST INSTRUMENT LABELING.—Unless 

14 the instrument is the entire test system, the labeling 

15 for an instrument is not required to bear the infor16 mation indicated in paragraphs (3), (4), (5), (7), 

17 (8), (9), (10), (11), (12), and (13) of section 

18 809.10(b) of title 21, Code of Federal Regulations 

19 (or any successor regulations). 

20 ‘‘(3) REAGENT LABELING.—For purposes of 

21 compliance with subsection (c)(1), the labeling for a 

22 reagent intended for use as a replacement in an in 

23 vitro clinical test may be limited to that information 

24 necessary to identify the reagent adequately and to 

25 describe its proper use in the test. 


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1 ‘‘(4) INVESTIGATIONAL USE.—A shipment or 

2 other delivery of an in vitro clinical test for inves3 tigational use pursuant to section 587S shall be ex4 empt from the labeling requirements of subsections 

5 (b) and (c)(1) and from any standard promulgated 

6 through regulations, except as required under sec7 tion 353 of the Public Health Service Act or section 

8 587R of this Act. 

9 ‘‘(5) GENERAL PURPOSE LABORATORY RE10 AGENTS.—The labeling of general purpose labora11 tory reagents (such as hydrochloric acid) whose uses 

12 are generally known by persons trained in their use 

13 need not bear the directions for use required by sub14 section (c)(1)(A). 

15 ‘‘(6) OVER-THE-COUNTER TEST SPECIMEN RE16 CEPTACLE LABELING.—The labeling for over-the17 counter test specimen receptacles for drugs of abuse 

18 testing shall bear the name and place of business of 

19 the developer included in the registration under sec20 tion 587J and any information specified in applica21 ble regulations promulgated under this section, in 

22 language appropriate for the intended users. 

23 ‘‘(e) TESTS IN THE STRATEGIC NATIONAL STOCK24 PILE.— 


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1 ‘‘(1) IN GENERAL.—The Secretary may grant 

2 an exception or alternative to any provision listed in 

3 this section, unless explicitly required by a statutory 

4 provision outside this subchapter, for specified lots, 

5 batches, or other units of an in vitro clinical test, if 

6 the Secretary determines that compliance with such 

7 labeling requirement could adversely affect the avail8 ability of such products that are, or will be, included 

9 in the Strategic National Stockpile under section 

10 319F–2 of the Public Health Service Act. 

11 ‘‘(2) REGULATIONS.—The Secretary may issue 

12 regulations amending section 809.11 of title 21, 

13 Code of Federal Regulations (or any successor regu14 lation) to apply in full or in part to in vitro clinical 

15 tests and in vitro clinical test developers. 

16 ‘‘(f) REGULATIONS.—The Secretary shall issue regu17 lations related to standardized, general content and for18 mat for in vitro clinical test labeling pursuant to this sub19 section. 

20 ‘‘SEC. 587M. ADVERSE EVENT REPORTING. 

21 ‘‘(a) IN GENERAL.—Each in vitro clinical test devel22 oper shall establish and maintain a system for establishing 

23 and maintaining records of adverse events and reporting 

24 adverse events in accordance with this section. 


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1 ‘‘(b) SUBMISSION OF INDIVIDUAL REPORTS.—A de2 veloper shall submit an individual adverse event report not 

3 later than 5 calendar days after the developer receives or 

4 becomes aware of an adverse event that reasonably sug5 gests that an in vitro clinical test may— 

6 ‘‘(1) have caused or contributed to a patient or 

7 user death; or 

8 ‘‘(2) present an imminent threat to public 

9 health. 

10 ‘‘(c) SUBMISSION OF QUARTERLY REPORTS.—As ap11 plicable, a developer shall submit quarterly reports that 

12 include any in vitro clinical test errors and serious injuries 

13 that occurred during the applicable quarter. Such quar14 terly reports shall be submitted not later than the end of 

15 the quarter following the quarter in which the developer 

16 receives or becomes aware of such adverse events. 

17 ‘‘(d) DEFINITIONS.—For the purposes of this sec18 tion— 

19 ‘‘(1) the term ‘in vitro clinical test error’ means 

20 a failure of an in vitro clinical test to meet its per21 formance specifications, or to otherwise perform as 

22 intended by the developer, including an inaccurate 

23 result resulting from such failure; and 

24 ‘‘(2) the term ‘serious injury’ means— 


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1 ‘‘(A) a significant delay in a diagnosis that 

2 results in the absence, delay, or discontinuation 

3 of critical medical treatment or that irreversibly 

4 or seriously and negatively alters the course of 

5 a disease or condition; or 

6 ‘‘(B) an injury that— 

7 ‘‘(i) is life threatening; 

8 ‘‘(ii) results in permanent impairment 

9 of a body function or permanent damage 

10 to a body structure; or 

11 ‘‘(iii) necessitates medical or surgical 

12 intervention to preclude permanent impair13 ment of a body function or permanent 

14 damage to a body structure. 

15 ‘‘(e) REGULATIONS.—The Secretary shall promulgate 

16 regulations to implement this section. 

17 ‘‘SEC. 587N. CORRECTIONS AND REMOVALS. 

18 ‘‘(a) REGULATIONS.—The Secretary shall promulgate 

19 regulations, or amend existing regulations, as appropriate, 

20 to implement this section. 

21 ‘‘(b) REPORTS OF CORRECTIONS AND REMOVALS.— 

22 ‘‘(1) IN GENERAL.—Each in vitro clinical test 

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1 taken by such developer if the correction or removal 

2 was undertaken— 

3 ‘‘(A) to reduce the risk to health posed by 

4 the in vitro clinical test; or 

5 ‘‘(B) to remedy a violation of this Act 

6 caused by the in vitro clinical test which may 

7 present a risk to health. 

8 ‘‘(2) EXCEPTION FOR IN VITRO CLINICAL TESTS

9 OFFERED UNDER A TECHNOLOGY CERTIFICATION

10 ORDER.—For any eligible test offered under a tech11 nology certification order under section 587D, a cor12 rection and removal report for any correction or re13 moval of an in vitro clinical test should demonstrate 

14 that the issue or issues causing the correction or re15 moval do not adversely impact the ability of other in 

16 vitro clinical tests offered under the same technology 

17 certification order to meet the applicable standard. 

18 ‘‘(c) TIMING.—A developer shall submit any report 

19 required under this subsection to the Secretary within 15 

20 business days of initiating such correction or removal. 

21 ‘‘(d) RECORDKEEPING.—A developer of an in vitro 

22 clinical test that undertakes a correction or removal of an 

23 in vitro clinical test which is not required to be reported 

24 under this subsection shall keep a record of such correc25 tion or removal. 


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1 ‘‘(e) RECALL COMMUNICATIONS.—Upon the report2 ing of a correction or removal by the developer— 

3 ‘‘(1) the Secretary shall classify such correction 

4 or removal under this section within 45 calendar 

5 days; and 

6 ‘‘(2) not later than 70 calendar days after the 

7 developer or other responsible party notifies the Sec8 retary that it has completed a recall action, the Sec9 retary shall provide the developer or other respon10 sible party with a written statement closing the re11 call action or stating the reasons the Secretary can12 not close the recall at that time. 

13 ‘‘SEC. 587O. RESTRICTED IN VITRO CLINICAL TESTS. 

14 ‘‘(a) APPLICABILITY.— 

15 ‘‘(1) IN GENERAL.—For the types of in vitro 

16 clinical tests described in paragraph (3), the Sec17 retary may require, in issuing an approval of an in 

18 vitro clinical test under section 587B, granting a 

19 technology certification order under section 587D, or 

20 in issuing a determination under section 587F(a), or 

21 by issuing a regulation, that such test, or category 

22 of tests, be restricted to sale, distribution, or use 

23 upon such conditions as the Secretary may prescribe 

24 under paragraph (2). 


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1 ‘‘(2) CONDITIONS.—The Secretary may pre2 scribe conditions under this section, based on avail3 able evidence, with respect to an in vitro clinical test 

4 described in paragraph (3), that are determined to 

5 be needed due to the potential for harmful effect of 

6 such test (including any resulting absence, signifi7 cant delay, or discontinuation of appropriate medical 

8 treatment), and are necessary to ensure that the test 

9 meets the applicable standard. 

10 ‘‘(3) IN VITRO CLINICAL TESTS SUBJECT TO

11 RESTRICTIONS.—The restrictions or conditions au12 thorized under this section may be applied by the 

13 Secretary to any high-risk or moderate-risk in vitro 

14 clinical test, prescription home-use in vitro clinical 

15 test, direct-to-consumer in vitro clinical test, or over16 the-counter in vitro clinical test. 

17 ‘‘(b) LABELING AND ADVERTISING OF A RESTRICTED

18 IN VITRO CLINICAL TEST.—The labeling and advertising 

19 of an in vitro clinical test to which restrictions apply under 

20 subsection (a) shall bear such appropriate statements of 

21 the restrictions as the Secretary may prescribe in an ap22 proval under section 587B, an order under section 587D, 

23 a determination under section 587F(a), or in regulation, 

24 as applicable. 


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1 ‘‘(c) DEVICE RESTRICTIONS.—An in vitro clinical 

2 test that was offered as a restricted device prior to the 

3 date of enactment of this subchapter— 

4 ‘‘(1) shall continue to comply with the applica5 ble restrictions under section 515 or section 520(e) 

6 until this subchapter takes effect; and 

7 ‘‘(2) except for in vitro clinical tests required to 

8 meet the requirements of section 809.30 of title 21, 

9 Code of Federal Regulations prior to the effective 

10 date of this subchapter specified in section 

11 5(a)(1)(A) of the VALID Act of 2023, such restric12 tions described in paragraph (1) shall be deemed to 

13 be restrictions under this subchapter as of such ef14 fective date. 

15 ‘‘SEC. 587P. APPEALS. 

16 ‘‘(a) SIGNIFICANT DECISION.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall— 

18 ‘‘(A) maintain a substantive summary of 

19 the scientific and regulatory rationale for any 

20 significant decision of the Food and Drug Ad21 ministration pursuant to section 587F, regard22 ing— 

23 ‘‘(i) the submission of an application 

24 for, or a review of, an in vitro clinical test 

25 under section 587B or section 587D; 


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1 ‘‘(ii) an exemption under section 

2 587C; or 

3 ‘‘(iii) any requirements for mitigation 

4 measures to an in vitro clinical test or cat5 egory of in vitro clinical tests; and 

6 ‘‘(B) include in such summaries docu7 mentation of significant controversies or dif8 ferences of opinion and the resolution of such 

9 controversies or differences of opinion. 

10 ‘‘(2) PROVISION OF DOCUMENTATION.—Upon 

11 request, the Secretary shall furnish a substantive 

12 summary described in paragraph (1) to the person 

13 who has made, or is seeking to make, a submission 

14 described in such paragraph. 

15 ‘‘(3) APPLICATION OF LEAST BURDENSOME RE16 QUIREMENTS.—The substantive summary required 

17 under this subsection shall include a brief statement 

18 regarding how the least burdensome requirements 

19 were considered and applied consistent with section 

20 587AA(c), as applicable. 

21 ‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 

22 ‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF

23 SIGNIFICANT DECISION.—A developer may request a 

24 supervisory review of the significant decision de25 scribed in subsection (a)(1). Such review may be 


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1 conducted at the next supervisory level or higher 

2 above the agency official who made the significant 

3 decision. 

4 ‘‘(2) SUBMISSION OF REQUEST.—A developer 

5 requesting a supervisory review under paragraph (1) 

6 shall submit such request to the Secretary not later 

7 than 30 days after the decision for which the review 

8 is requested and shall indicate in the request wheth9 er such developer seeks an in-person meeting or a 

10 teleconference review. 

11 ‘‘(3) TIMEFRAME.—The Secretary shall sched12 ule an in-person or teleconference review, if so re13 quested, not later than 30 days after such request 

14 is made. The Secretary shall issue a decision to the 

15 developer requesting a review under this subsection 

16 not later than 45 days after the request is made 

17 under paragraph (1), or, in the case of a developer 

18 who requests an in-person meeting or teleconference, 

19 30 days after such meeting or teleconference. 

20 ‘‘(c) ADVISORY PANELS.—The process established 

21 under subsection (a) shall permit the appellant to request 

22 review by an advisory committee established under section 

23 587G when there is a dispute involving substantial sci24 entific fact. If an advisory panel meeting is held, the Sec25 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 2023, 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 587J. 

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, FINDING, AND REC17 OMMENDATION REQUIREMENTS.—An accredited 

18 person receiving an application for premarket 

19 approval under section 587B shall either— 

20 ‘‘(i) provide to the Secretary, together 

21 with the application for premarket ap22 proval submitted by the applicant, a rec23 ommendation based on a finding that the 

24 criteria for approval of the application 

25 under section 587B(e)(2)(A) are met and 


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1 issue a copy of such finding to the appli2 cant, which finding shall plainly state— 

3 ‘‘(I) the basis for the accredited 

4 person’s finding that the criteria 

5 under section 587B(e)(2)(A) are met; 

6 and 

7 ‘‘(II) any proposed restrictions, 

8 mitigating measures, or conditions of 

9 approval under section 587B(e)(2)(B), 

10 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(e)(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 from an accredited person under this 

19 section, the Secretary may request missing or 

20 clarifying information from the applicant con21 cerning the application, which the accredited 

22 person shall promptly provide. 

23 ‘‘(C) SECRETARY ACTION ON REC24 OMMENDATION THAT APPROVAL CRITERIA ARE

25 MET.—If the accredited person transmits a recVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00149 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 ommendation to the Secretary under subpara2 graph (A)(i), then prior to the date that is 45 

3 calendar days after the transmittal date, the 

4 Secretary shall consider such recommendation 

5 and make a determination to— 

6 ‘‘(i) approve the application for pre7 market approval under section 587B(e)(2) 

8 with appropriate restrictions, mitigating 

9 measures, or conditions of approval, as ap10 plicable; or 

11 ‘‘(ii) deny approval of the application 

12 by issuing a written notice that reflects ap13 propriate management input and concur14 rence to the accredited person and the ap15 plicant detailing the scientific basis for the 

16 Secretary’s determination that the criteria 

17 for issuance of an approval under section 

18 587B(e)(2)(A) have not been met. 

19 ‘‘(D) EFFECT OF INACTION ON REC20 OMMENDATION.—If the Secretary fails to take 

21 an action under subparagraph (C) the Sec22 retary shall— 

23 ‘‘(i) within 45 calendar days after the 

24 transmittal date, provide written feedback 

25 to the applicant that— 


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1 ‘‘(I) includes all outstanding 

2 issues with the application preventing 

3 the Secretary from taking an action 

4 under subparagraph (B); 

5 ‘‘(II) reflects appropriate man6 agement input and concurrence; and 

7 ‘‘(III) includes action items for 

8 the Secretary, the applicant, or both, 

9 as appropriate, with an estimated date 

10 of completion for the Secretary and 

11 the applicant to complete their respec12 tive tasks, as applicable; and 

13 ‘‘(ii) promptly schedule a meeting or 

14 teleconference to discuss the feedback pro15 vided under clause (i), unless the Secretary 

16 and applicant agree that the outstanding 

17 issues are adequately presented through 

18 written correspondence and a meeting or 

19 teleconference is not necessary. 

20 ‘‘(2) REQUIREMENTS FOR TECHNOLOGY CER21 TIFICATION.— 

22 ‘‘(A) REVIEW AND RECOMMENDATION RE23 QUIREMENTS.—An accredited person receiving 

24 an application for technology certification under 

25 section 587D shall either— 


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1 ‘‘(i) provide to the Secretary, together 

2 with the application for technology certifi3 cation submitted by the applicant, a rec4 ommendation that the criteria for issuance 

5 of a technology certification order under 

6 section 587D(d)(3) are met and issue a 

7 copy of such recommendation to the appli8 cant, which recommendation shall plainly 

9 state the basis for the accredited person’s 

10 recommendation that the criteria under 

11 section 587D(d)(3) are met; or 

12 ‘‘(ii) provide a notification to the ap13 plicant that the accredited person cannot 

14 recommend that the criteria for issuance of 

15 a technology certification order under sec16 tion 587D(d)(3) are met and the reasons 

17 for such decision. 

18 ‘‘(B) REQUESTING MISSING OR CLARI19 FYING INFORMATION.—After receipt of an ap20 plication under this section, the accredited per21 son may request missing or clarifying informa22 tion from the applicant concerning the applica23 tion, which the applicant shall promptly pro24 vide. 


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1 ‘‘(C) SECRETARY ACTION ON REC2 OMMENDATION FOR ISSUANCE OF A TECH3 NOLOGY CERTIFICATION ORDER.—If the accred4 ited person transmits a recommendation to the 

5 Secretary under clause (i) of subparagraph (A), 

6 then prior to the date that is 60 calendar days 

7 after the transmittal date the Secretary shall— 

8 ‘‘(i) issue the technology certification 

9 order under section 587D(d)(3), consistent 

10 with such recommendation from the ac11 credited person; or 

12 ‘‘(ii) deny approval of the application 

13 by issuing a written notice to the accred14 ited person and the applicant detailing the 

15 scientific basis for a determination by the 

16 Secretary that the criteria for issuance of 

17 a technology certification order under sec18 tion 587D(d)(3) have not been met. 

19 ‘‘(c) REQUIREMENTS FOR INSPECTIONS.— 

20 ‘‘(1) IN GENERAL.—When conducting inspec21 tion, persons accredited under subsection (a)(1)(C) 

22 shall record in writing their specific observations and 

23 shall present their observations to the designated 

24 representative of the inspected establishment. 


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1 ‘‘(2) INSPECTION REPORT REQUIREMENTS.— 

2 Each person accredited under subsection (a)(1)(C) 

3 shall prepare and submit to the Secretary an inspec4 tion report in a form and manner designated by the 

5 Secretary for conducting inspections. Any statement 

6 or representation made by an employee or agent of 

7 an establishment to a person accredited to conduct 

8 inspections under subsection (a)(1)(C) shall be sub9 ject to section 1001 of title 18, United States Code. 

10 ‘‘(3) SAVINGS CLAUSE.—Nothing in this section 

11 affects the authority of the Secretary to inspect any 

12 in vitro clinical test developer or other person reg13 istered under section 587J or recognize inspections 

14 conducted by auditing organizations as described 

15 under section 704(g)(15). 

16 ‘‘(4) INSPECTION LIMITATIONS.—The Secretary 

17 shall ensure that inspections carried out under this 

18 section are not duplicative of inspections carried out 

19 under section 353 of the Public Health Service Act. 

20 Inspections under this section shall be limited to the 

21 data and information necessary— 

22 ‘‘(A) for routine surveillance activities of 

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1 nology certification order under section 587D; 

2 or 

3 ‘‘(B) to meet the requirements for pre4 market approval under section 587B or 

5 issuance of a technology certification order 

6 under section 587D, as applicable. 

7 ‘‘(d) ACCREDITATION.— 

8 ‘‘(1) ACCREDITATION PROGRAM.—The Sec9 retary may provide for accreditation under this sec10 tion through programs administered by the Food 

11 and Drug Administration, by other non-Federal gov12 ernment agencies, or by qualified nongovernmental 

13 organizations. A person may be accredited for the 

14 review of applications submitted under sections 

15 587B as described in subsection (a)(1)(A), for the 

16 review of applications submitted under section 587D 

17 as described in subsection (a)(1)(B), and to conduct 

18 inspection activities under subsection (a)(1)(C), or 

19 for a subset of such reviews or activities. 

20 ‘‘(2) ELIGIBLE PERSONS.— 

21 ‘‘(A) MINIMUM QUALIFICATIONS.—An ac22 credited person, at a minimum, shall— 

23 ‘‘(i) not be an employee of the Federal 

24 Government; 


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1 ‘‘(ii) not engage in the activities of a 

2 developer, as defined in section 587(7); 

3 ‘‘(iii) not be a person required to reg4 ister under section 587J, unless such per5 son has established sufficient processes 

6 and protocols to separate activities to de7 velop in vitro clinical tests and the activi8 ties for which such person would be ac9 credited under subsection (a) and discloses 

10 applicable information under this section; 

11 ‘‘(iv) not be owned or controlled by, 

12 and shall have no organizational, material, 

13 or financial affiliation with, an in vitro 

14 clinical test developer or other person re15 quired to register under section 587J; 

16 ‘‘(v) be a legally constituted entity 

17 permitted to conduct the activities for 

18 which it seeks accreditation; 

19 ‘‘(vi) ensure that the operations of 

20 such person are in accordance with gen21 erally accepted professional and ethical 

22 business practices; and 

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1 forming activities pursuant to this sec2 tion— 

3 ‘‘(I) certify that the information 

4 reported to the Secretary accurately 

5 reflects the data or protocol reviewed, 

6 and the documented inspection find7 ings, as applicable; 

8 ‘‘(II) limit work to that for which 

9 competence and capacity are available; 

10 ‘‘(III) treat information received 

11 or learned, records, reports, and rec12 ommendations as proprietary informa13 tion of the person submitting such in14 formation; and 

15 ‘‘(IV) in conducting the activities 

16 for which the person is accredited in 

17 respect to a particular in vitro clinical 

18 test, protect against the use of any 

19 employee or consultant who has a fi20 nancial conflict of interest regarding 

21 that in vitro clinical test. 

22 ‘‘(B) WAIVER.—The Secretary may waive 

23 any requirements in clause (i), (ii), (iii), or (iv) 

24 of subparagraph (A) upon making a determina25 tion that such person has implemented other 


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1 appropriate controls sufficient to ensure a com2 petent and impartial review. 

3 ‘‘(3) ACCREDITATION PROCESS.— 

4 ‘‘(A) ACCREDITATION PROCESS GUIDANCE

5 AND REGULATIONS.—Not later than 180 days 

6 after the date of enactment of the VALID Act 

7 of 2023, the Secretary shall issue draft guid8 ance specifying the process for submitting a re9 quest for accreditation and reaccreditation 

10 under this section, including the form and con11 tent of information to be submitted, including 

12 the criteria that the Secretary will consider to 

13 accredit or deny accreditation and, not later 

14 than 1 year after the close of the comment pe15 riod for the draft guidance, issue final guid16 ance. 

17 ‘‘(B) RESPONSE TO REQUEST.—The Sec18 retary shall respond to a request for accredita19 tion or reaccreditation within 60 calendar days 

20 of the receipt of the request. The Secretary’s 

21 response may be to accredit or reaccredit the 

22 person, to deny accreditation, or to request ad23 ditional information in support of the request. 

24 If the Secretary requests additional informa25 tion, the Secretary shall respond within 60 calVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00158 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 endar days of receipt of such additional infor2 mation to accredit or deny the accreditation. 

3 ‘‘(C) TYPE OF ACCREDITATION.—The ac4 creditation or reaccreditation of a person shall 

5 specify the particular activity or activities under 

6 subsection (a) for which such person is accred7 ited, and shall include any limitation to certain 

8 eligible in vitro clinical tests. 

9 ‘‘(D) PUBLIC LIST.—The Secretary shall 

10 publish on the website of the Food and Drug 

11 Administration a list of persons who are accred12 ited under this section. Such list shall be up13 dated on at least a monthly basis. The list shall 

14 specify the particular activity or activities under 

15 this section for which the person is accredited. 

16 ‘‘(E) AUDIT.—The Secretary may audit 

17 the performance of persons accredited under 

18 this section for purposes of ensuring that such 

19 persons continue to meet the published criteria 

20 for accreditation, and may modify the scope or 

21 particular activities for which a person is ac22 credited if the Secretary determines that such 

23 person fails to meet one or more criteria for ac24 creditation. 


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1 ‘‘(F) SUSPENSION OR WITHDRAWAL.—The 

2 Secretary may suspend or withdraw accredita3 tion of any person accredited under this section, 

4 after providing notice and an opportunity for an 

5 informal hearing, when such person is substan6 tially not in compliance with the requirements 

7 of this section or the published criteria for ac8 creditation, or poses a threat to public health, 

9 or fails to act in a manner that is consistent 

10 with the purposes of this section. 

11 ‘‘(G) REACCREDITATION.—Accredited per12 sons may be initially accredited for up to 3 

13 years. After expiration of such initial period, 

14 persons may be reaccredited for unlimited addi15 tional 5-year periods, as determined by the Sec16 retary. 

17 ‘‘(e) COMPENSATION OF ACCREDITED PERSONS.— 

18 Compensation of an accredited person shall be determined 

19 by agreement between the accredited person and the per20 son who engages the services of the accredited person, and 

21 shall be paid by the person who engages such services. 

22 ‘‘(f) INTERNATIONAL HARMONIZATION.—Notwith23 standing any other provision of this section, to facilitate 

24 international harmonization the Secretary may recognize 

25 persons accredited or recognized by governments, who 


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1 have also entered into information sharing agreements, in2 cluding confidentiality commitments, with the Commis3 sioner of Food and Drugs. 

4 ‘‘(g) INFORMATION SHARING AGREEMENTS.—An ac5 credited person may enter into an agreement with a test 

6 developer to provide information to the comprehensive test 

7 information system under section 587T, including any re8 quirements under section 587J. 

9 ‘‘(h) REPORTS.—Not later than 2 years after the ef10 fective date of the VALID Act of 2023, and annually 

11 thereafter for the next 4 years, the Secretary shall post 

12 on the website of the Food and Drug Administration, a 

13 report describing the Secretary’s performance in imple14 menting this section, including the Secretary’s progress in 

15 minimizing duplicative reviews of applications for which 

16 an accredited person finds the criteria for approval are 

17 met. Such reports shall include, for each period— 

18 ‘‘(1) with regard to premarket approval applica19 tions— 

20 ‘‘(A) the total number of findings trans21 mitted to the Secretary under subsection 

22 (b)(1)(A)(i); 

23 ‘‘(B) the total number of determinations 

24 made by the Secretary under subsection 


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1 (b)(1)(B)(i) within 30 calendar days of the 

2 transmittal date to approve an application; 

3 ‘‘(C) the total number of determinations 

4 made by the Secretary under subsection 

5 (b)(1)(B)(ii) within 30 calendar days of the 

6 transmittal date to deny approval of an applica7 tion; and 

8 ‘‘(D) the total number of applications that 

9 were approved and the total number of applica10 tions that were denied approval, after the Sec11 retary failed to make a determination within 30 

12 calendar days of the transmittal date under 

13 subsection (b)(1)(B); and 

14 ‘‘(2) with regard to applications for technology 

15 certification— 

16 ‘‘(A) the total number of recommendations 

17 transmitted to the Secretary under subsection 

18 (b)(2)(A)(i); 

19 ‘‘(B) the total number of determinations 

20 made by the Secretary under subsection 

21 (b)(2)(B)(i) to issue a technology certification 

22 order, including determinations made within 30 

23 days of the transmittal date; 

24 ‘‘(C) the total number of determinations 

25 made by the Secretary under subsection 


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1 (b)(2)(B)(ii) to deny the application for tech2 nology certification, including determinations 

3 made within 30 calendar days of the trans4 mittal date; and 

5 ‘‘(D) the total number of technology cer6 tification orders issued, and the total number of 

7 applications for technology certification that 

8 were denied, including applications denied after 

9 the Secretary failed to make a determination 

10 within 30 calendar days of the transmittal date 

11 under subsection (b)(2)(B). 

12 ‘‘SEC. 587R. RECOGNIZED STANDARDS. 

13 ‘‘(a) IN GENERAL.—The Secretary may recognize all 

14 or part of appropriate standards established by nationally 

15 or internationally recognized standards development orga16 nizations for which a person may submit a declaration of 

17 conformity in order to meet a requirement under this sub18 chapter to which that standard is applicable. Standards 

19 for in vitro diagnostic devices previously recognized under 

20 section 514(c) shall be considered recognized standards 

21 under this section. Recognized and proposed standards 

22 shall be accessible to the public at no charge. The applica23 tion of any such consensus standard shall only apply pro24 spectively. The Secretary shall issue regulations estabVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00163 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 lishing the criteria and process, for such recognition and 

2 adoption. 

3 ‘‘(b) AMENDMENT PROCESS.—The procedures estab4 lished in this section or in regulation or guidance issued 

5 under this section shall apply to amendment of an existing 

6 standard. 

7 ‘‘SEC. 587S. INVESTIGATIONAL USE. 

8 ‘‘(a) IN GENERAL.—Subject to the conditions pre9 scribed in subsections (c), (d), (e), (f), and (g), an in vitro 

10 clinical test for investigational use shall be exempt from 

11 the requirements of this subchapter, other than sections 

12 587A, 587P, 587T, and 587V. The Secretary may amend 

13 parts 50, 54, and 56 of title 21 of the Code of Federal 

14 Regulations to apply to in vitro clinical tests to permit 

15 the investigational use of such tests by experts qualified 

16 by scientific training and experience. 

17 ‘‘(b) REGULATIONS.— 

18 ‘‘(1) IN GENERAL.—Not later than 3 years 

19 after the date of enactment of the VALID Act of 

20 2023, the Secretary shall promulgate regulations to 

21 implement this section. 

22 ‘‘(2) VARIATION.—The requirements in the reg23 ulations promulgated under this section shall take 

24 into account variations based on— 


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1 ‘‘(A) the scope and duration of clinical 

2 testing to be conducted under investigation that 

3 is the subject of such application; 

4 ‘‘(B) the number of human subjects that 

5 are to be involved in such testing; 

6 ‘‘(C) the need to permit changes to be 

7 made to the in vitro clinical test involved during 

8 testing conducted in accordance with a plan re9 quired under subsection (c)(6); or 

10 ‘‘(D) whether the clinical testing of such in 

11 vitro clinical test is for the purpose of devel12 oping data to obtain approval to offer such test. 

13 ‘‘(c) APPLICATION FOR INVESTIGATIONAL USE.— 

14 The following shall apply with respect to in vitro clinical 

15 tests for investigational use: 

16 ‘‘(1) SIGNIFICANT RISK AND OTHER STUD17 IES.—In the case of an in vitro clinical test the in18 vestigational use of which poses a significant risk to 

19 the human subject or involves an exception from in20 formed consent for emergency research, a sponsor of 

21 an investigation of such a test seeking an investiga22 tional use exemption shall submit to the Secretary 

23 an investigational use application with respect to the 

24 in vitro clinical test in accordance with paragraphs 

25 (3) and (4). 


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1 ‘‘(2) NON-SIGNIFICANT RISK STUDIES.—In the 

2 case of an in vitro clinical test, the investigational 

3 use of which is not described in paragraph (1)— 

4 ‘‘(A) the sponsor of such investigation 

5 shall— 

6 ‘‘(i) ensure such investigation is con7 ducted in compliance with an investiga8 tional plan approved by an institutional re9 view committee and the labeling of the in 

10 vitro clinical test involved clearly and con11 spicuously states, ‘For investigational use 

12 only’, as specified in paragraph (4)(A)(ii); 

13 ‘‘(ii) ensure each investigator obtains 

14 informed consent as required under part 

15 50, 54, and 56 of title 21, Code of Federal 

16 Regulations (or any successor regulations), 

17 subject to the exceptions set forth in para18 graph (6)(C); 

19 ‘‘(iii) establish and maintain records 

20 with respect to all requirements in this 

21 subparagraph; 

22 ‘‘(iv) maintain records and make re23 ports as required by the Secretary pursu24 ant to regulations issued under subsection 

25 (b); and 


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1 ‘‘(v) ensure that investigators monitor 

2 investigations, maintain records and make 

3 reports as required by the Secretary pursu4 ant to regulations issued under subsection 

5 (b); and 

6 ‘‘(B) the sponsor may rely on any excep7 tion or exemption described in paragraph (4) or 

8 as established by the Secretary in regulations 

9 issued under subsection (b). 

10 ‘‘(3) APPLICATION.—An investigational use ap11 plication shall be submitted in such time and man12 ner and contain such information as the Secretary 

13 may require in regulation, and shall include an in14 vestigational plan for proposed clinical testing and 

15 assurances that the sponsor submitting the applica16 tion will— 

17 ‘‘(A) establish and maintain records rel18 evant to the investigation of such in vitro clin19 ical test; and 

20 ‘‘(B) submit to the Secretary annual re21 ports of data obtained as a result of the inves22 tigational use of the in vitro clinical test during 

23 the period covered by the exemption that the 

24 Secretary reasonably determines will enable the 

25 Secretary— 


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1 ‘‘(i) to ensure compliance with the 

2 conditions for the exemption specified in 

3 paragraph (4); 

4 ‘‘(ii) to review the progress of the in5 vestigation involved; and 

6 ‘‘(iii) to evaluate the ability to meet 

7 the applicable standard. 

8 ‘‘(4) CONDITIONS FOR EXEMPTION.—An appli9 cation for an investigational use exemption with re10 spect to a significant risk study shall be granted if 

11 each of the following conditions is met: 

12 ‘‘(A) The risks to the subjects of the in 

13 vitro clinical test are outweighed by the antici14 pated benefits of the test to the subjects and 

15 the importance of the knowledge to be gained, 

16 and adequate assurance of informed consent is 

17 provided in accordance with paragraphs (6)(B) 

18 and (6)(C). 

19 ‘‘(B) The proposed labeling for the in vitro 

20 clinical test involved clearly and conspicuously 

21 states ‘For investigational use only’. 

22 ‘‘(C) Such other requirements the Sec23 retary determines— 

24 ‘‘(i) are necessary for the protection 

25 of the public health and safety; and 


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1 ‘‘(ii) do not unduly delay investiga2 tion. 

3 ‘‘(5) COORDINATION WITH INVESTIGATIONAL

4 NEW DRUG APPLICATIONS.—Any requirement for 

5 the submission of a report to the Secretary pursuant 

6 to an application for an investigational new drug ex7 emption involving an in vitro clinical test shall su8 persede the reporting requirement under paragraph 

9 (3)(B), but only to the extent the requirement with 

10 respect to the application for exemption with respect 

11 to the drug is duplicative of the reporting require12 ment under such paragraph. 

13 ‘‘(6) INVESTIGATIONAL PLAN, PROCEDURES, 

14 AND CONDITIONS.—With respect to an investiga15 tional plan submitted under paragraph (3), the 

16 sponsor submitting such plan shall— 

17 ‘‘(A) promptly notify the Secretary of the 

18 approval or the suspension or termination of 

19 the approval of such plan by an institutional re20 view committee; 

21 ‘‘(B) in the case of an in vitro clinical test 

22 made available to investigators for clinical test23 ing, obtain agreements from each investigator 

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1 vestigator’s supervision and in accordance with 

2 paragraph (C) and submit such agreements to 

3 the Secretary that ensure— 

4 ‘‘(i) all investigators will comply with 

5 this section, regulations promulgated or re6 vised under this section, and applicable 

7 human subjects regulations; and 

8 ‘‘(ii) the investigator will ensure 

9 that— 

10 ‘‘(I) informed consent is obtained 

11 as required under part 50 of title 21, 

12 Code of Federal Regulations (or any 

13 successor regulations), amended to 

14 apply to in vitro clinical tests; and 

15 ‘‘(II) the requirements for insti16 tutional review board under part 56 of 

17 title 21 of the Code of Federal Regu18 lations (or successor regulations), 

19 amended to apply to in vitro clinical 

20 tests, are met; and 

21 ‘‘(C) ensure that informed consent will be 

22 obtained from each human subject (or the rep23 resentative of such subject) of proposed clinical 

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1 cept where, subject to such other conditions as 

2 the Secretary may prescribe— 

3 ‘‘(i) the proposed clinical testing poses 

4 no more than minimal risk to the human 

5 subject and includes appropriate safe6 guards to protect the rights, safety, and 

7 welfare of the human subject; or 

8 ‘‘(ii) the investigator conducting or 

9 supervising the clinical testing determines 

10 in writing that there exists a life-threat11 ening situation involving the human sub12 ject of such testing which necessitates the 

13 use of such in vitro clinical test and it is 

14 not feasible to obtain informed consent 

15 from the subject and there is not sufficient 

16 time to obtain such consent from a rep17 resentative of such subject. 

18 ‘‘(7) CONCURRED BY LICENSED PHYSICIAN.— 

19 The determination required by paragraph (6)(C)(ii) 

20 shall be concurred in writing by a licensed physician 

21 who is not involved in the testing of the human sub22 ject with respect to which such determination is 

23 made unless immediate use of the in vitro clinical 

24 test is required to save the life of the human subject 


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1 of such testing and there is not sufficient time to ob2 tain such concurrence. 

3 ‘‘(8) SIGNIFICANT RISK.—For purposes of this 

4 subsection, the term ‘significant risk’ means, with 

5 respect to an in vitro clinical test, that the use of 

6 such in vitro clinical test— 

7 ‘‘(A) is of substantial importance in per8 forming an activity or activities described in 

9 section 201(ss)(1) for, a serious or life-threat10 ening disease or condition without confirmation 

11 of the diagnosis by a medically established diag12 nostic product or procedure; 

13 ‘‘(B) requires an invasive sampling proce14 dure that presents a significant risk to the 

15 human subject, provided that routine 

16 venipuncture shall not be considered an invasive 

17 sampling procedure; or 

18 ‘‘(C) otherwise presents a potential for se19 rious risk to the health of a human subject. 

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 30 calendar days after the date of the 

3 submission of an application for an investigational 

4 use exemption that meets the requirements of sub5 section (c), issues an order under paragraph (1) and 

6 notifies the sponsor submitting the application, the 

7 application shall be treated as approved as of such 

8 date without further action by the Secretary. 

9 ‘‘(3) DENIAL.—The Secretary may deny an in10 vestigational use application submitted under this 

11 subsection if the Secretary determines that the in12 vestigation with respect to which the application is 

13 submitted does not conform to the requirements of 

14 subsection (c). A notification of such denial sub15 mitted to the sponsor with respect to such a request 

16 shall contain the order of disapproval and a complete 

17 statement of the reasons for the Secretary’s denial 

18 of the application. 

19 ‘‘(e) WITHDRAWAL OF EXEMPTION.— 

20 ‘‘(1) IN GENERAL.—The Secretary may, by ad21 ministrative order, withdraw an exemption approved 

22 under this section with respect to an in vitro clinical 

23 test, including an exemption treated as approved 

24 based on the Secretary’s failure to act pursuant to 

25 subsection (d)(2), if the Secretary determines that 


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1 an investigation conducted under such an exemption 

2 does not meet the applicable conditions under sub3 section (c)(3) for such exemption. 

4 ‘‘(2) OPPORTUNITY TO BE HEARD.— 

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graph (B), an order withdrawing an investiga7 tional use exemption granted under this section 

8 may be issued only after the Secretary provides 

9 the sponsor of the in vitro clinical test with an 

10 opportunity for an informal hearing. 

11 ‘‘(B) EXCEPTION.—An order referred to in 

12 subparagraph (A) with respect to an investiga13 tional use exemption granted under this section 

14 may be issued on a preliminary basis before the 

15 provision of an opportunity for an informal 

16 hearing if the Secretary determines that the 

17 continuation of testing under the exemption will 

18 result in an unreasonable risk to the public 

19 health. The Secretary will provide an oppor20 tunity for an informal hearing promptly fol21 lowing any preliminary action under this sub22 paragraph. 

23 ‘‘(f) CHANGES.— 

24 ‘‘(1) IN GENERAL.—The regulations promul25 gated under subsection (b) shall provide, with reVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00174 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 spect to an in vitro clinical test for which an exemp2 tion under this subsection is in effect, procedures 

3 and conditions under which changes are allowed 

4 without the additional approval of an application for 

5 an exemption or submission of a supplement to such 

6 an application. Such regulations shall provide that 

7 such a change may be made if— 

8 ‘‘(A) the sponsor determines, on the basis 

9 of credible information (as defined in regula10 tions) that the change meets the conditions 

11 specified in paragraph (2); and 

12 ‘‘(B) the sponsor submits to the Secretary, 

13 not later than 5 calendar days after making the 

14 change, a notice of the change. 

15 ‘‘(2) CONDITIONS.—The conditions specified in 

16 this paragraph are that— 

17 ‘‘(A) in the case of developmental changes 

18 to an in vitro clinical test, including manufac19 turing changes, the changes— 

20 ‘‘(i) do not constitute a significant 

21 change in design or in basic principles of 

22 operation; 

23 ‘‘(ii) do not affect the rights, safety, 

24 or welfare of the human subjects involved 

25 in the investigation; and 


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1 ‘‘(iii) are made in response to infor2 mation gathered during the course of an 

3 investigation; and 

4 ‘‘(B) in the case of changes to clinical pro5 tocols applicable to the test, the changes do not 

6 affect— 

7 ‘‘(i) the validity of data or information 

8 resulting from the completion of an ap9 proved clinical protocol, or the relationship 

10 of likely patient risk to benefit relied upon 

11 to approve a product; 

12 ‘‘(ii) the scientific soundness of a plan 

13 submitted under subsection (c)(3); or 

14 ‘‘(iii) the rights, safety, or welfare of 

15 the human subjects involved in the inves16 tigation. 

17 ‘‘(g) CLINICAL HOLD.— 

18 ‘‘(1) IN GENERAL.—At any time, the Secretary 

19 may impose a clinical hold with respect to an inves20 tigation of an in vitro clinical test if the Secretary 

21 makes a written determination described in para22 graph (2). The Secretary shall, in imposing such 

23 clinical hold, specify the basis for the clinical hold, 

24 including the specific information available to the 

25 Secretary which served as the basis for such clinical 


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1 hold, and confirm such determination in writing. 

2 The applicant may immediately appeal any such de3 termination pursuant to section 587P. 

4 ‘‘(2) DETERMINATION.— 

5 ‘‘(A) IN GENERAL.—For purposes of para6 graph (1), a determination described in this 

7 subparagraph with respect to a clinical hold is 

8 a determination that, based on credible evi9 dence, the in vitro clinical test involved rep10 resents an unreasonable risk to the safety of 

11 the persons who are the subjects of the clinical 

12 investigation, taking into account the qualifica13 tions of the clinical investigators, information 

14 about the in vitro clinical test, the design of the 

15 clinical investigation, the condition for which 

16 the in vitro clinical test is to be investigated, 

17 and the health status of the subjects involved. 

18 ‘‘(B) REMOVAL OF CLINICAL HOLD.—Any 

19 written request to the Secretary from the spon20 sor of an investigation that a clinical hold be re21 moved shall receive a decision, in writing and 

22 specifying the reasons therefor, within 30 days 

23 after receipt of such request. Any such request 

24 shall include sufficient information to support 

25 the removal of such clinical hold. 


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1 ‘‘SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM. 

2 ‘‘(a) ESTABLISHMENT.—Not later than 2 years after 

3 the date of enactment of the VALID Act of 2023, the Sec4 retary shall make available a comprehensive test informa5 tion system for in vitro clinical tests that is designed to— 

6 ‘‘(1) provide a transparent interface on the 

7 website of the Food and Drug Administration for 

8 stakeholders, to the extent permitted by applicable 

9 law, which may include access to the— 

10 ‘‘(A) regulatory pathway designation infor11 mation for each in vitro clinical test or tests 

12 with the same indications for use; 

13 ‘‘(B) registration and listing information 

14 provided by developers under section 587J, in15 cluding the use of a link for labels; 

16 ‘‘(C) adverse event reports submitted 

17 under section 587M, as appropriate; 

18 ‘‘(D) reports of corrections and removals 

19 submitted under section 587N; and 

20 ‘‘(E) other information pertaining to an in 

21 vitro clinical test or tests with the same indica22 tions for use, as the Secretary determines ap23 propriate; and 

24 ‘‘(2) provide a secure portal for electronic sub25 mission, including applications and other in vitro 

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1 formation, and adverse event reports, which provides 

2 protections from unauthorized disclosure of informa3 tion, including of— 

4 ‘‘(A) trade secret or confidential commer5 cial or financial information; and 

6 ‘‘(B) information that could compromise 

7 national security. 

8 ‘‘(b) SUBMISSION FUNCTION.—The comprehensive 

9 test information system shall serve as the electronic sub10 mission service for test developers submitting information 

11 for applications under sections 587B and 587D. 

12 ‘‘SEC. 587U. PREEMPTION. 

13 ‘‘(a) IN GENERAL.—Except as provided in subsection 

14 (b), no State, Tribal, or local government (or political sub15 division thereof) may establish or continue in effect any 

16 requirement— 

17 ‘‘(1) that is different from, or in addition to, 

18 any requirement applicable to an in vitro clinical test 

19 under this Act; or 

20 ‘‘(2) with respect to the analytical validity, clin21 ical validity, or safety for individuals who come into 

22 contact with such an in vitro clinical test. 

23 ‘‘(b) EXCEPTIONS.—Subsection (a) shall not be con24 strued to affect the authority of a State, Tribal, or local 

25 government to do any of the following: 


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1 ‘‘(1) To license laboratory personnel, health 

2 care practitioners, or health care facilities or to reg3 ulate any aspect of a health care practitioner-patient 

4 relationship. 

5 ‘‘(2) To enforce laws of general applicability, 

6 such as zoning laws, environmental laws, labor laws, 

7 and general business laws. 

8 ‘‘(3) To authorize laboratories to develop and 

9 perform an in vitro clinical test, pursuant to a law 

10 enacted by a State prior to January 1, 2022, as long 

11 as such law does not impose requirements that are 

12 different from any requirement applicable to an in 

13 vitro clinical test under this Act. If a State has en14 acted such a law, the Secretary shall exempt such 

15 test for laboratories in that State from compliance 

16 with this subchapter. 

17 ‘‘(c) CLARIFICATION.—Nothing in this section shall 

18 be construed to— 

19 ‘‘(1) modify any action for damages or the li20 ability of any person under the law of any State; or 

21 ‘‘(2) shift liability to health care practitioners 

22 or other users. 

23 ‘‘SEC. 587V. ADULTERATION. 

24 ‘‘An in vitro clinical test shall be deemed to be adul25 terated: 


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1 ‘‘(1) If it consists in whole or in part of any 

2 filthy, putrid, or decomposed substance. 

3 ‘‘(2) If it has been developed, prepared, packed, 

4 or held under insanitary conditions whereby it may 

5 have been contaminated with filth, or whereby it 

6 may have been rendered injurious to health. 

7 ‘‘(3) If its container or package is composed, in 

8 whole or in part, of any poisonous or deleterious 

9 substance which may render the contents injurious 

10 to health. 

11 ‘‘(4) If it bears or contains, for purposes of 

12 coloring only, a color additive which is unsafe within 

13 the meaning of section 721(a). 

14 ‘‘(5) If its analytical or clinical validity, as ap15 plicable, or with respect to a specimen receptacle, its 

16 safety, falls below that which it purports or is rep17 resented to possess. 

18 ‘‘(6) If it is required to be, declared to be, pur19 ports to be, or is represented as being, in conformity 

20 with any performance standard established or recog21 nized under section 587R and is not in conformity 

22 with such standard. 

23 ‘‘(7) If it is required to be in compliance with 

24 mitigating measures established under section 587E 


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1 and is not in conformity with such mitigating meas2 ures. 

3 ‘‘(8) If it fails to have in effect an approved 

4 premarket application under section 587B, unless 

5 such in vitro clinical test is in compliance with the 

6 requirements for— 

7 ‘‘(A) offering without an approved pre8 market application under section 587D(b)(1); 

9 ‘‘(B) an exemption from premarket ap10 proval under section 587C or 587G; or 

11 ‘‘(C) investigational use pursuant to sec12 tion 587S. 

13 ‘‘(9) If it is not in conformity with any condi14 tion established under section 587B or 587D. 

15 ‘‘(10) If it purports to be an in vitro clinical 

16 test subject to an exemption under section 587C and 

17 it fails to meet or maintain any criteria, condition, 

18 or requirement of such exemption. 

19 ‘‘(11) If it has been granted an exemption 

20 under section 587S for investigational use, and the 

21 person granted such exemption or any investigator 

22 who uses such in vitro clinical test under such ex23 emption fails to comply with a requirement pre24 scribed by or under such section. 


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1 ‘‘(12) If it fails to meet the quality require2 ments prescribed in or established under section 

3 587K (as applicable), or the methods used in, or fa4 cilities or controls used for, its development, pack5 aging, storage, or installation are not in conformity 

6 with applicable requirements established under such 

7 section. 

8 ‘‘(13) If it has been developed, processed, pack9 aged, or held in any establishment, factory, or ware10 house and the owner, operator or agent of such es11 tablishment, factory, or warehouse delays, denies, or 

12 limits an inspection, or refuses to permit entry or in13 spection. 

14 ‘‘(14) If it is not in compliance with any restric15 tion required under section 587O. 

16 ‘‘SEC. 587W. MISBRANDING. 

17 ‘‘An in vitro clinical test shall be deemed to be mis18 branded: 

19 ‘‘(1) If its labeling is false or misleading in any 

20 particular. 

21 ‘‘(2) If in a package form unless it bears a label 

22 containing— 

23 ‘‘(A) the name and place of business of the 

24 test developer, packager, or distributor; and 


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1 ‘‘(B) an accurate statement of the quantity 

2 of contents in terms of weight, measure, or nu3 merical count, unless an exemption is granted 

4 by the Secretary by the issuance of guidance, 

5 such as with respect to small packages. 

6 ‘‘(3) If any word, statement, or other informa7 tion required by or under authority of this Act to 

8 appear on the label or labeling, including a test re9 port, is not prominently placed thereon with such 

10 conspicuousness (as compared with other words, 

11 statements, designs, or devices, in the labeling) and 

12 in such terms as to render it likely to be read and 

13 understood by the ordinary individual under cus14 tomary conditions of purchase and use. 

15 ‘‘(4) Unless its labeling bears adequate direc16 tions for use and such adequate warnings as are 

17 necessary for the protection of users of the in vitro 

18 clinical test and recipients of the results of such in 

19 vitro clinical test, including patients, consumers, do20 nors, and related health care professionals. Required 

21 labeling for in vitro clinical tests intended for use in 

22 health care facilities, blood establishments, or by a 

23 health care professional may be made available solely 

24 by electronic means, provided that the labeling com25 plies with all applicable requirements of law, and 


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1 that the test developer, or distributor affords such 

2 users the opportunity to request the labeling in 

3 paper form, and after such request, promptly pro4 vides the requested information without additional 

5 cost. 

6 ‘‘(5) If there is a reasonable probability that it 

7 could cause serious or adverse health consequences 

8 or death, including through absence, delay, or dis9 continuation in diagnosis or treatment, when used in 

10 the manner prescribed, recommended, or suggested 

11 in the labeling thereof. 

12 ‘‘(6) If it was developed, sterilized, packaged, 

13 repackaged, relabeled, installed, or imported in an 

14 establishment not duly registered under section 

15 587J or it was not included in a listing under sec16 tion 587J, in accordance with timely reporting re17 quirements under this subchapter. 

18 ‘‘(7) In the case of any in vitro clinical test sub19 ject to restrictions under section 587O, (1) if its ad20 vertising is false or misleading in any particular, (2) 

21 if it is offered for clinical use, sold, distributed, or 

22 used in violation of such restrictions, or (3) unless 

23 the test developer or distributor includes in all ad24 vertisements and other descriptive printed matter 

25 that such person issues or causes to be issued, a 


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1 brief statement of the indications for use of the in 

2 vitro clinical test and relevant warnings, precautions, 

3 side effects, and contraindications. This paragraph 

4 shall not be applicable to any printed matter that 

5 the Secretary determines to be labeling as defined in 

6 section 201(m). 

7 ‘‘(8) If it is subject to a mitigating measure es8 tablished under section 587E and does not bear such 

9 labeling as may be prescribed in such mitigating 

10 measure. 

11 ‘‘(9) If it is subject to a standard established 

12 under section 587R and it does not bear such label13 ing as may be prescribed in such standard. 

14 ‘‘(10) Unless it bears such labeling as may be 

15 required by or established under an applicable label16 ing requirement under this Act. 

17 ‘‘(11) If there was a failure to comply with any 

18 requirement prescribed in or under section 587D, 

19 587J, 587K, 587L, 587M, 587N, 587X, 587Y, 

20 587Z, or to provide any report, material, or other in21 formation required with respect to in vitro clinical 

22 tests under this subchapter. 

23 ‘‘SEC. 587X. POSTMARKET SURVEILLANCE. 

24 ‘‘(a) IN GENERAL.— 


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1 ‘‘(1) IN GENERAL.—In addition to other appli2 cable requirements under this Act, the Secretary 

3 may issue an order requiring a developer of a high4 risk or moderate-risk in vitro clinical test to conduct 

5 postmarket surveillance of such in vitro clinical test, 

6 if the failure of the in vitro clinical test is reasonably 

7 likely to result in serious adverse health con8 sequences or death from use of such in vitro clinical 

9 test. 

10 ‘‘(2) CONSIDERATION.—In determining whether 

11 to require a developer to conduct postmarket surveil12 lance of an in vitro clinical test, the Secretary shall 

13 take into consideration the benefits and risks for the 

14 patient and the least burdensome requirements 

15 under section 587AA(c). 

16 ‘‘(b) SURVEILLANCE APPROVAL.— 

17 ‘‘(1) IN GENERAL.—Each developer required to 

18 conduct surveillance of an in vitro clinical test shall 

19 submit, within 30 days of receiving an order from 

20 the Secretary, a plan for the required surveillance. 

21 The Secretary, within 60 days of the receipt of such 

22 plan, shall determine if the person designated to 

23 conduct the surveillance has the appropriate quali24 fications and experience to undertake such surveil25 lance and if the plan will result in useful data that 


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1 can reveal unforeseen adverse events or other infor2 mation necessary to protect the health of patients or 

3 the public. 

4 ‘‘(2) TIMELINE.—The developer shall com5 mence surveillance under this section not later than 

6 15 months after the day on which the Secretary or7 ders such postmarket surveillance, unless the Sec8 retary determines more time is needed to commence 

9 surveillance. 

10 ‘‘(3) PROSPECTIVE SURVEILLANCE.—The Sec11 retary may order a prospective surveillance period of 

12 up to 3 years. Any determination by the Secretary 

13 that a longer period is necessary shall be made by 

14 mutual agreement between the Secretary and the de15 veloper or, if no agreement can be reached, upon the 

16 completion of a dispute resolution process pursuant 

17 to section 562. 

18 ‘‘SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS. 

19 ‘‘(a) IN GENERAL.—All submissions to the Food and 

20 Drug Administration with respect to an in vitro clinical 

21 test, unless otherwise agreed to by the Secretary, shall— 

22 ‘‘(1) be made electronically; and 

23 ‘‘(2) with respect to the information required 

24 under sections 587B and 587D, utilize the system 

25 described in section 587T. 


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1 ‘‘(b) ELECTRONIC FORMAT.—Beginning on such date 

2 as the Secretary specifies in final guidance issued under 

3 subsection (c), submissions for in vitro clinical tests, in4 cluding recommendations submitted by accredited and rec5 ognized persons under section 587Q, and any appeals of 

6 action taken by the Secretary with respect to such submis7 sions, shall be submitted in such electronic format as spec8 ified by the Secretary in such guidance. 

9 ‘‘(c) GUIDANCE.—The Secretary shall issue guidance 

10 implementing this section. Such guidance may— 

11 ‘‘(1) provide standards for the electronic sub12 mission required under subsection (a) or the submis13 sion in electronic format required under subsection 

14 (b); 

15 ‘‘(2) set forth criteria for waivers of, or exemp16 tions from, the requirements of subsection (a) or (b); 

17 and 

18 ‘‘(3) provide any other information for the effi19 cient implementation and enforcement of this sec20 tion. 

21 ‘‘SEC. 587Z. POSTMARKET REMEDIES. 

22 ‘‘(a) SAFETY NOTICE.— 

23 ‘‘(1) IN GENERAL.—If the Secretary determines 

24 that an in vitro clinical test presents an unreason25 able risk of substantial harm to the public health, 


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1 and notification under this subsection is necessary to 

2 eliminate the unreasonable risk of such harm and no 

3 more practicable means is available under the provi4 sions of this Act (other than this section) to elimi5 nate the risk, the Secretary may issue such order as 

6 may be necessary to ensure that adequate safety no7 tice is provided in an appropriate form, by the per8 sons and means best suited under the circumstances, 

9 to all health care professionals who prescribe, order, 

10 or use the in vitro clinical test and to any other per11 son (including developers, importers, distributors, re12 tailers, and users) who should properly receive such 

13 notice. 

14 ‘‘(2) NOTICE TO INDIVIDUALS.—An order 

15 under this subsection shall require that the individ16 uals subject to the risk with respect to which the 

17 order is to be issued be included in the persons to 

18 be notified of the risk unless the Secretary deter19 mines that notice to such individuals would present 

20 a greater danger to the health of such individuals 

21 than no such notice. If the Secretary makes such a 

22 determination with respect to such individuals, the 

23 order shall require the health care professionals who 

24 prescribed, ordered, or used the in vitro clinical test 

25 provide notification to the individuals for whom the 


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1 health professionals prescribed, ordered, or used 

2 such test, of the risk presented by such in vitro clin3 ical test and of any action which may be taken by 

4 or on behalf of such individuals to eliminate or re5 duce such risk. Before issuing an order under this 

6 subsection, the Secretary shall consult with the per7 sons required to give notice under the order. 

8 ‘‘(b) REPAIR, REPLACEMENT, OR REFUND.— 

9 ‘‘(1) DETERMINATION AFTER AN INFORMAL

10 HEARING.— 

11 ‘‘(A) IN GENERAL.—If, after affording op12 portunity for an informal hearing, the Secretary 

13 determines that— 

14 ‘‘(i) an in vitro clinical test presents 

15 an unreasonable risk of substantial harm 

16 to the public health; 

17 ‘‘(ii) there are reasonable grounds to 

18 believe that the in vitro clinical test was 

19 not properly developed or manufactured 

20 considering the state of the art as it ex21 isted at the time of its development; 

22 ‘‘(iii) there are reasonable grounds to 

23 believe that the unreasonable risk was not 

24 caused by failure of a person other than a 

25 developer, importer, distributor, or retailer 


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1 of the in vitro clinical test to exercise due 

2 care in the installation, maintenance, re3 pair, or use of the in vitro clinical test; and 

4 ‘‘(iv) the notice authorized by sub5 section (a) would not by itself be sufficient 

6 to eliminate the unreasonable risk and ac7 tion described in paragraph (2) of this sub8 section is necessary to eliminate such risk, 

9 the Secretary may order the developer, im10 porter, or any distributor of such in vitro clin11 ical test, or any combination of such persons, to 

12 submit to him within a reasonable time a plan 

13 for taking one or more of the actions described 

14 in paragraph (2). An order issued under the 

15 preceding sentence which is directed to more 

16 than one person shall specify which person may 

17 decide which action shall be taken under such 

18 plan and the person specified shall be the per19 son who the Secretary determines bears the 

20 principal, ultimate financial responsibility for 

21 action taken under the plan unless the Sec22 retary cannot determine who bears such respon23 sibility or the Secretary determines that the 

24 protection of the public health requires that 

25 such decision be made by a person (including a 


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1 health professional or user of the in vitro clin2 ical test) other than the person the Secretary 

3 determines bears such responsibility. 

4 ‘‘(B) SECRETARY APPROVAL OF PLAN.— 

5 The Secretary shall approve a plan submitted 

6 pursuant to an order issued under subpara7 graph (A) unless the Secretary determines 

8 (after affording opportunity for an informal 

9 hearing) that the action or actions to be taken 

10 under the plan or the manner in which such ac11 tion or actions are to be taken under the plan 

12 will not assure that the unreasonable risk with 

13 respect to which such order was issued will be 

14 eliminated. If the Secretary disapproves a plan, 

15 the Secretary shall order a revised plan to be 

16 submitted within a reasonable time. If the Sec17 retary determines (after affording opportunity 

18 for an informal hearing) that the revised plan 

19 is unsatisfactory or if no revised plan or no ini20 tial plan has been submitted to the Secretary 

21 within the prescribed time, the Secretary 

22 shall— 

23 ‘‘(i) prescribe a plan to be carried out 

24 by the person or persons to whom the 


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1 order issued under subparagraph (A) was 

2 directed; or 

3 ‘‘(ii) after affording an opportunity 

4 for an informal hearing, by order prescribe 

5 a plan to be carried out by a person who 

6 is a developer, importer, distributor, or re7 tailer of the in vitro clinical test with re8 spect to which the order was issued but to 

9 whom the order under subparagraph (A) 

10 was not directed. 

11 ‘‘(2) ACTIONS ON A PLAN.—The actions that 

12 may be taken under a plan submitted under an 

13 order issued under paragraph (1)(A) are as follows: 

14 ‘‘(A) To repair the in vitro clinical test so 

15 that it does not present the unreasonable risk 

16 of substantial harm with respect to which the 

17 order under paragraph (1)(A) was issued. 

18 ‘‘(B) To replace the in vitro clinical test 

19 with a like or equivalent test which is in con20 formity with all applicable requirements of this 

21 Act. 

22 ‘‘(C) To refund the purchase price of the 

23 in vitro clinical test (less a reasonable allowance 

24 for use if such in vitro clinical test has been in 

25 the possession of the user for one year or more 


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1 at the time of notice ordered under subsection 

2 (a), or at the time the user receives actual no3 tice of the unreasonable risk with respect to 

4 which the order was issued under paragraph 

5 (1)(A), whichever occurs first). 

6 ‘‘(3) NO CHARGE.—No charge shall be made to 

7 any person (other than a developer, importer, dis8 tributor, or retailer) for using a remedy described in 

9 paragraph (2) and provided under an order issued 

10 under paragraph (1), and the person subject to the 

11 order shall reimburse each person (other than a de12 veloper, manufacturer, importer, distributor, or re13 tailer) who is entitled to such a remedy for any rea14 sonable and foreseeable expenses actually incurred 

15 by such person in using such remedy. 

16 ‘‘(c) REIMBURSEMENT.—An order issued under sub17 section (b)(1)(A) with respect to an in vitro clinical test 

18 may require any person who is a developer, importer, dis19 tributor, or retailer of the in vitro clinical test to reimburse 

20 any other person who is a developer, importer, distributor, 

21 or retailer of such in vitro clinical test for such other per22 son’s expenses actually incurred in connection with car23 rying out the order if the Secretary determines such reim24 bursement is required for the protection of the public 

25 health. Any such requirement shall not affect any rights 


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1 or obligations under any contract to which the person re2 ceiving reimbursement or the person making such reim3 bursement is a party. 

4 ‘‘(d) RECALL AUTHORITY.— 

5 ‘‘(1) IN GENERAL.—If the Secretary finds that 

6 there is a reasonable probability that an in vitro 

7 clinical test approved under section 587B or offered 

8 under a technology certification order under section 

9 587D would cause serious, adverse health con10 sequences or death, including by the absence, signifi11 cant delay, or discontinuation of appropriate medical 

12 treatment, the Secretary shall issue an order requir13 ing the appropriate person (including the developers, 

14 importers, distributors, or retailers of the in vitro 

15 clinical test)— 

16 ‘‘(A) to immediately cease distribution of 

17 such in vitro clinical test; and 

18 ‘‘(B) to immediately notify health profes19 sionals and applicable in vitro clinical test user 

20 facilities of the order and to instruct such pro21 fessionals and facilities to cease use of such in 

22 vitro clinical test. 

23 ‘‘(2) INFORMAL HEARING.—The order issued 

24 under paragraph (1)(A), shall provide the person 

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1 formal hearing, to be held not later than 10 calendar 

2 days after the date of the issuance of the order, on 

3 the actions required by the order and on whether the 

4 order should be amended to require a recall of such 

5 in vitro clinical test. If, after providing an oppor6 tunity for such a hearing, the Secretary determines 

7 that inadequate grounds exist to support the actions 

8 required by the order, the Secretary shall vacate the 

9 order. 

10 ‘‘(3) AMENDED ORDER.— 

11 ‘‘(A) IN GENERAL.—If, after providing an 

12 opportunity for an informal hearing under 

13 paragraph (2), the Secretary determines that 

14 the order should be amended to include a recall 

15 of the in vitro clinical test with respect to which 

16 the order was issued, the Secretary shall, except 

17 as provided in subparagraph (B), amend the 

18 order to require a recall. The Secretary shall 

19 specify a timetable in which the recall will occur 

20 and shall require periodic reports describing the 

21 progress of the recall. 

22 ‘‘(B) REQUIREMENTS.—An amended order 

23 under subparagraph (A)— 

24 ‘‘(i) shall not include recall of the in 

25 vitro clinical test from individuals; 


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1 ‘‘(ii) shall not include recall of an in 

2 vitro clinical test from test user facilities if 

3 the Secretary determines that the risk of 

4 recalling such in vitro clinical test from the 

5 facilities presents a greater health risk 

6 than the health risk of not recalling the in 

7 vitro clinical test from use; and 

8 ‘‘(iii) shall provide for notice to indi9 viduals subject to the risks associated with 

10 the use of such in vitro clinical test. In 

11 providing the notice required by this 

12 clause, the Secretary may use the assist13 ance of health professionals who pre14 scribed, ordered, or used such an in vitro 

15 clinical test for individuals. 

16 ‘‘(4) CLARIFICATION.—The remedy provided by 

17 this subsection shall be in addition to remedies pro18 vided by subsections (a), (b), and (c). 

19 ‘‘SEC. 587AA. APPLICABILITY. 

20 ‘‘(a) IN GENERAL.—An in vitro clinical test shall be 

21 subject to the requirements of this subchapter, except as 

22 otherwise provided in this subchapter. Laboratory oper23 ations shall not be subject to the requirements of this sub24 chapter. 


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1 ‘‘(b) INTERSTATE COMMERCE.—Any in vitro clinical 

2 test that is offered, including by making available for clin3 ical use in the United States is deemed to be an act that 

4 constitutes introduction into interstate commerce for pur5 poses of enforcing the requirements of this Act. 

6 ‘‘(c) LEAST BURDENSOME REQUIREMENTS.— 

7 ‘‘(1) IN GENERAL.—In carrying out this sub8 chapter, the Secretary shall consider the least bur9 densome means necessary to meet the applicable 

10 standard, and other regulatory requirements, as de11 termined by the Secretary. 

12 ‘‘(2) NECESSARY DEFINED.—For purposes of 

13 paragraph (1), the term ‘necessary’ means the min14 imum required information that would support a de15 termination by the Secretary that the application 

16 meet the applicable standard or regulatory require17 ment, as determined by the Secretary. 

18 ‘‘(d) SERVICE OF ORDERS.—Orders of the Secretary 

19 under this section with respect to applications under sub20 section (a) or (b) of section 587B or supplements under 

21 subsection (f) of such section shall be served— 

22 ‘‘(1) in person by any officer or employee of the 

23 Department of Health and Human Services des24 ignated by the Secretary; or 


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1 ‘‘(2) by mailing the order by registered mail or 

2 certified mail or electronic equivalent addressed to 

3 the applicant at the last known address in the 

4 records of the Secretary. 

5 ‘‘(e) LABORATORIES AND BLOOD AND TISSUE ES6 TABLISHMENTS.— 

7 ‘‘(1) RELATION TO LABORATORY CERTIFI8 CATION PURSUANT TO SECTION 353 OF THE PUBLIC

9 HEALTH SERVICE ACT.—Nothing in this subchapter 

10 shall be construed to modify the authority of the 

11 Secretary with respect to laboratories or clinical lab12 oratories under section 353 of the Public Health 

13 Service Act. 

14 ‘‘(2) AVOIDING DUPLICATION.—In imple15 menting this subchapter, the Secretary shall avoid 

16 issuing or enforcing regulations or guidance that are 

17 duplicative of regulations or guidance under section 

18 353 of the Public Health Service Act such that lab19 oratories would be subject to conflicting regulatory 

20 obligations with respect to the same activity. 

21 ‘‘(3) BLOOD AND TISSUE.—Nothing in this sub22 chapter shall be construed to modify the authority of 

23 the Secretary with respect to laboratories, establish24 ments, or other facilities to the extent they are en25 gaged in the propagation, manufacture, or preparaVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00200 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 tion, including filling, labeling, packaging, and stor2 age, of blood, blood components, human cells, tis3 sues, or tissue products pursuant to any require4 ments under this Act or section 351 or 361 of the 

5 Public Health Service Act. 

6 ‘‘(f) NOT COMBINATION PRODUCT.— 

7 ‘‘(1) IN GENERAL.—A product constituted of a 

8 device and an in vitro clinical test is not a combina9 tion product and may be regulated as a device or as 

10 a device and in vitro clinical test, notwithstanding 

11 section 201(ss)(3). 

12 ‘‘(2) GUIDANCE.—Not later than October 1, 

13 2026, the Secretary shall issue final guidance, after 

14 an opportunity for public comment, addressing the 

15 considerations for regulating a product described in 

16 paragraph (1). Such guidance shall take into ac17 count the least burdensome requirements under sub18 section (c). 

19 ‘‘(g) PRACTICE OF MEDICINE.—Nothing in this sub20 chapter shall be construed to limit or interfere with the 

21 authority of a health care practitioner to prescribe or ad22 minister any lawfully offered in vitro clinical test for any 

23 condition or disease within a legitimate health care practi24 tioner-patient relationship pursuant to applicable Federal 

25 or State law. 


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1 ‘‘(h) SALE, DISTRIBUTION, LABELING.—Nothing in 

2 this section shall be construed to limit the authority of 

3 the Secretary to establish or enforce restrictions on the 

4 sale, distribution, or labeling of an in vitro clinical test 

5 under this Act. 

6 ‘‘(i) PROMOTION OF UNAPPROVED USES.—Nothing 

7 in this section shall be construed to alter any prohibition 

8 on the promotion of unapproved uses of legally offered in 

9 vitro clinical tests. 

10 ‘‘(j) VOLUNTARY SUBMISSIONS.—Nothing in section 

11 587C shall be construed to prevent a developer developing 

12 a test described in such section, including an academic 

13 medical center laboratory described in subsection (a)(7) 

14 of such section, from filing an application under section 

15 587B or section 587D, or from adhering to the require16 ments of section 587K with regard to a test protocol de17 scribed in section 587K or for any other test or use of 

18 a test. 

19 ‘‘SEC. 587BB. JUDICIAL REVIEW. 

20 ‘‘(a) IN GENERAL.—Not later than 30 days after an 

21 order issued pursuant to section 587B or 587D, any per22 son adversely affected by such order may file a petition 

23 with the United States Court of Appeals for the District 

24 of Columbia or for the circuit wherein such person resides 

25 or has a principal place of business for judicial review of 


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1 such order, in accordance with the procedure set forth in 

2 section 517(a). 

3 ‘‘(b) APPLICATION OF PROVISIONS.—Subsections (a) 

4 through (e) of section 517 shall apply with respect to a 

5 petition under subsection (a) of this section in the same 

6 manner such subsections apply to a petition under section 

7 517. Subsection (f) of section 517 shall apply to an order 

8 issued under section 587B or 587D.’’. 

9 SEC. 4. ENFORCEMENT AND OTHER PROVISIONS. 

10 (a) PROHIBITED ACTS.—Section 301 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend12 ed— 

13 (1) in paragraphs (a), (b), (c), (g), (h), (k), (q), 

14 (r), and (y), by inserting ‘‘in vitro clinical test,’’ 

15 after ‘‘device,’’ each place it appears; 

16 (2) in paragraph (g), by inserting after ‘‘mis17 branded’’ the following: ‘‘, and the development 

18 within any Territory of any in vitro clinical test that 

19 is adulterated or misbranded’’; 

20 (3) in paragraph (y), by inserting ‘‘or 587Q’’ 

21 after ‘‘section 523’’ each place it appears; 

22 (4) in paragraph (ff), by striking ‘‘or device’’ 

23 and inserting ‘‘, device, or in vitro clinical test’’; and 

24 (5) by adding at the end, the following: 


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1 ‘‘(fff)(1) Forging, counterfeiting, simulating, or false2 ly representing, or without proper authority using any 

3 mark, stamp, tag, label, or other identification upon any 

4 in vitro clinical test or container, packaging, or labeling 

5 thereof so as to render such in vitro clinical test a counter6 feit in vitro clinical test. 

7 ‘‘(2) Making, selling, disposing of, or keeping in pos8 session, control, or custody, or concealing any punch, die, 

9 plate, stone, or other thing designed to print, imprint, or 

10 reproduce the trademark, trade name, or other identifying 

11 mark or imprint of another or any likeness of any of the 

12 foregoing upon any in vitro clinical test or container, pack13 aging, or labeling thereof so as to render such in vitro 

14 clinical test a counterfeit in vitro clinical test. 

15 ‘‘(3) The doing of any act which causes an in vitro 

16 clinical test to be a counterfeit in vitro clinical test, or 

17 the sale or dispensing, or the holding for sale or dis18 pensing, of a counterfeit in vitro clinical test. 

19 ‘‘(ggg)(1) The introduction or delivery for introduc20 tion into interstate commerce of an in vitro clinical test 

21 in violation of section 587A(a). 

22 ‘‘(2) The making of a false, fraudulent, or deceptive 

23 statement about an in vitro clinical test that is exempt 

24 from premarket review under section 587C. 


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1 ‘‘(3) The failure to maintain complete and accurate 

2 documentation for an exemption as required under section 

3 587C or the failure to provide labeling required under sec4 tion 587L. 

5 ‘‘(4) With respect to an in vitro clinical test, the sub6 mission of any application, report, or listing under this 

7 Act that is false or misleading in any material respect. 

8 ‘‘(5) The failure to comply with a condition of ap9 proval, or restriction required under an approved applica10 tion under section 587B; the failure to perform a risk 

11 analysis required by section 587B; the failure to submit 

12 an annual update required under section 587J(c)(2)(B); 

13 or the failure to complete postmarket surveillance as re14 quired under section 587X. 

15 ‘‘(6) The failure to comply with applicable require16 ments to submit an application or report under section 

17 587D(e). 

18 ‘‘(7) The failure to comply with applicable mitigating 

19 measures established under section 587E or to submit, 

20 maintain, or make available the documentation required 

21 under section 587E(b); or the failure to comply with appli22 cable performance standards established under section 

23 587R. 

24 ‘‘(8) The failure to register in accordance with section 

25 587J, the failure to provide information required under 


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1 section 587J(b), or the failure to maintain or submit infor2 mation required under section 587J(c). 

3 ‘‘(9) The failure to comply with requirements under 

4 section 587M or 587N, the failure to comply with a re5 striction required under section 587O, or the failure to 

6 comply with labeling and advertising requirements under 

7 section 587O(b). 

8 ‘‘(10) The failure to comply with the requirements 

9 of section 587Q. 

10 ‘‘(11) The failure to comply with any requirement of 

11 section 587S; the failure to furnish any notification, infor12 mation, material, or report required under section 587S; 

13 or the failure to comply with an order issued under section 

14 587S. 

15 ‘‘(12) The failure to furnish information requested by 

16 the Secretary under 587G(d)(2).’’. 

17 (b) PENALTIES.—Section 303 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 333) is amended— 

19 (1) in subsection (b)(8), by inserting ‘‘or coun20 terfeit in vitro clinical test’’ after ‘‘counterfeit drug’’; 

21 (2) in subsection (c)— 

22 (A) by striking ‘‘; or (5)’’ and inserting ‘‘; 

23 (5)’’; and 

24 (B) by inserting before the period at the 

25 end the following: ‘‘; or (6) for having violated 


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1 section 301(fff)(2) if such person acted in good 

2 faith and had no reason to believe that use of 

3 the punch, die, plate, stone, or other thing in4 volved would result in an in vitro clinical test 

5 being a counterfeit in vitro clinical test, or for 

6 having violated section 301(fff)(3) if the person 

7 doing the act or causing it to be done acted in 

8 good faith and had no reason to believe that the 

9 in vitro clinical test was a counterfeit in vitro 

10 clinical test’’; and 

11 (3) in subsection (f)(1)— 

12 (A) in subparagraph (A)— 

13 (i) by inserting ‘‘or in vitro clinical 

14 tests’’ after ‘‘which relates to devices’’; 

15 (ii) by inserting ‘‘or section 

16 587Q(a)(1)’’ after ‘‘section 704(g)’’; and 

17 (iii) by inserting ‘‘or in vitro clinical 

18 tests, as applicable’’ before the period at 

19 the end of the second sentence; and 

20 (B) in subparagraph (B)(i), by striking ‘‘or 

21 520(f)’’ and inserting ‘‘, 520(f), 587K, or 

22 587M,’’. 

23 (c) SEIZURE.—Section 304 of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 334) is amended— 

25 (1) in subsection (a)(2)— 


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1 (A) by striking ‘‘, and (E)’’ and inserting 

2 ‘‘, (E)’’; and 

3 (B) by inserting before the period at the 

4 end the following: ‘‘, and (F) Any in vitro clin5 ical test that is a counterfeit in vitro clinical 

6 test, (G) Any container, packaging, or labeling 

7 of a counterfeit in vitro clinical test, and (H) 

8 Any punch, die, plate, stone, labeling, container, 

9 or other thing used or designed for use in mak10 ing a counterfeit in vitro clinical test’’; 

11 (2) in subsection (d)(1), by inserting ‘‘in vitro 

12 clinical test,’’ after ‘‘device,’’; and 

13 (3) in subsection (g)— 

14 (A) in paragraph (1), by inserting ‘‘, in 

15 vitro clinical test,’’ after ‘‘device’’ each place it 

16 appears; and 

17 (B) in paragraph (2)— 

18 (i) in subparagraph (A), by inserting 

19 ‘‘, in vitro clinical test,’’ after ‘‘device’’; 

20 and 

21 (ii) in subparagraph (B), by inserting 

22 ‘‘or in vitro clinical test’’ after ‘‘device’’ 

23 each place it appears. 

24 (d) DEBARMENT, TEMPORARY DENIAL OF AP25 PROVAL, AND SUSPENSION.—Section 306 of the Federal 


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1 Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is 

2 amended by adding at the end the following: 

3 ‘‘(n) IN VITRO CLINICAL TESTS; MANDATORY DE4 BARMENT REGARDING THIRD-PARTY INSPECTIONS AND

5 REVIEWS.— 

6 ‘‘(1) IN GENERAL.—If the Secretary finds that 

7 a person has been convicted of a felony for a viola8 tion of section 301(gg) or 301(fff)(1), the Secretary 

9 shall debar such person from being accredited under 

10 section 587Q and from carrying out activities under 

11 an agreement described in section 803(b). 

12 ‘‘(2) DEBARMENT PERIOD.—The Secretary 

13 shall debar a person under paragraph (1) for the fol14 lowing periods: 

15 ‘‘(A) The period of debarment of a person 

16 (other than an individual) shall not be less than 

17 1 year or more than 10 years, but if an act 

18 leading to a subsequent debarment under such 

19 paragraph occurs within 10 years after such 

20 person has been debarred under such para21 graph, the period of debarment shall be perma22 nent. 

23 ‘‘(B) The debarment of an individual shall 

24 be permanent. 


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1 ‘‘(3) TERMINATION OF DEBARMENT; JUDICIAL

2 REVIEW; OTHER MATTERS.—Subsections (c)(3), (d), 

3 (e), (i), (j), and (l)(1) apply with respect to a person 

4 (other than an individual) or an individual who is 

5 debarred under paragraph (1) to the same extent 

6 and in the same manner as such subsections apply 

7 with respect to a person who is debarred under sub8 section (a)(1), or an individual who is debarred 

9 under subsection (a)(2), respectively.’’. 

10 (e) EXPANDED ACCESS TO UNAPPROVED THERAPIES

11 AND DIAGNOSTICS.—Section 561 of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 360bbb) is amend13 ed— 

14 (1) in subsections (a) through (d)— 

15 (A) by striking ‘‘or investigational devices’’ 

16 each place it appears and inserting ‘‘, investiga17 tional devices, or investigational in vitro clinical 

18 tests’’; and 

19 (B) by striking ‘‘or investigational device’’ 

20 each place it appears (other than the second 

21 such place in paragraph (3)(A)) of subsection 

22 (c)) and inserting ‘‘, investigational device, or 

23 investigational in vitro clinical test’’; 


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1 (2) in subsection (b)(4) by striking ‘‘or 520(g)’’ 

2 each place it appears and inserting ‘‘, 520(g), or 

3 587S’’; 

4 (3) in subsection (c)— 

5 (A) by amending the subsection heading to 

6 read: ‘‘TREATMENT INVESTIGATIONAL NEW

7 DRUG APPLICATIONS, TREATMENT INVESTIGA8 TIONAL DEVICE EXEMPTIONS, AND TREAT9 MENT INVESTIGATIONAL IN VITRO CLINICAL

10 TEST EXEMPTIONS.’’; 

11 (B) in paragraph (3)(A), by striking ‘‘or 

12 investigational device exemption in effect under 

13 section 520(g)’’ and inserting ‘‘, investigational 

14 device exemption in effect under section 520(g), 

15 or investigational in vitro clinical test exemption 

16 under section 587S’’; 

17 (C) by striking ‘‘or treatment investiga18 tional device exemption’’ each place it appears 

19 and inserting ‘‘, treatment investigational device 

20 exemption, or treatment investigational in vitro 

21 clinical test exemption’’; 

22 (D) in paragraph (5), by striking ‘‘or 

23 520(g)’’ and inserting ‘‘, 520(g), or 587S’’; and 


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1 (E) in the matter following paragraph (7) 

2 by striking ‘‘or 520(g)’’ each place it appears 

3 and inserting ‘‘, 520(g), or 587S’’; and 

4 (4) by amending subsection (e) to read as fol5 lows: 

6 ‘‘(e) DEFINITIONS.—In this section, the terms ‘inves7 tigational drug’, ‘investigational device’, ‘investigational in 

8 vitro clinical test’, ‘treatment investigational new drug ap9 plication’, ‘treatment investigational device exemption’, 

10 and ‘treatment investigational in vitro clinical test exemp11 tion’ shall have the meanings given the terms in regula12 tions prescribed by the Secretary.’’. 

13 (f) OPTIMIZING GLOBAL CLINICAL TRIALS.—Section 

14 569A(b) of the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 360bbb–8a(b)) is amended— 

16 (1) by striking ‘‘subsection’’ each place it ap17 pears and inserting ‘‘paragraph’’; and 

18 (2) by inserting ‘‘an in vitro clinical test, as de19 fined in paragraph (ss) of such section,’’ before ‘‘or 

20 a biological product’’. 

21 (g) PATIENT PARTICIPATION IN MEDICAL PRODUCT

22 DISCUSSION.—The heading of subsection (a) of section 

23 569C of the Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 360bbb–8c) is amended by striking ‘‘DRUGS AND


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1 DEVICES’’ and inserting ‘‘DRUGS, DEVICES, AND IN

2 VITRO CLINICAL TESTS’’. 

3 (h) REGULATIONS AND HEARINGS.—Clause (ii) of 

4 section 701(h)(1)(C) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 371(h)(1)(C)) is amended— 

6 (1) by inserting ‘‘and in vitro clinical tests’’ 

7 after ‘‘devices’’; and 

8 (2) by moving the margin of such clause 2 ems 

9 to the left. 

10 (i) RECORDS.—Section 703 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 373) is amended— 

12 (1) by inserting ‘‘in vitro clinical tests,’’ after 

13 ‘‘devices,’’ each place such term appears; and 

14 (2) by inserting ‘‘in vitro clinical test,’’ after 

15 ‘‘device,’’ each place such term appears. 

16 (j) FACTORY INSPECTION.—Section 704 of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) (other 

18 than subsection (g)) is amended— 

19 (1) by striking ‘‘drugs or devices’’ each place it 

20 appears and inserting ‘‘drugs, devices, or in vitro 

21 clinical tests’’; 

22 (2) in subsection (a)(1), in the fourth sentence, 

23 by striking ‘‘or chapter IX’’ and inserting ‘‘section 

24 587S, section 587M, section 587N, or chapter IX’’; 


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1 (3) after making the amendments in para2 graphs (1) and (2), by inserting ‘‘in vitro clinical 

3 tests,’’ after ‘‘devices,’’ each place it appears; 

4 (4) in subsection (a)(2)(B)— 

5 (A) by inserting ‘‘or in vitro clinical tests’’ 

6 after ‘‘prescribe or use devices’’; and 

7 (B) by inserting ‘‘or in vitro clinical tests’’ 

8 after ‘‘process devices’’; 

9 (5) by inserting ‘‘in vitro clinical test,’’ after 

10 ‘‘device,’’ each place it appears; 

11 (6) in subsection (e), by inserting ‘‘, or section 

12 587M, 587N, or 587S,’’ after ‘‘section 519 or 

13 520(g)’’; 

14 (7) in subsection (f)(3)— 

15 (A) in subparagraph (A), by striking ‘‘or’’ 

16 at the end; 

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

18 period at the end and inserting ‘‘; or’’; and 

19 (C) after subparagraph (B), by inserting 

20 the following: 

21 ‘‘(C) is accredited under section 587Q.’’; 

22 and 

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


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1 ‘‘(i) For purposes of this section, the term ‘establish2 ment’ includes a laboratory performing an in vitro clinical 

3 test.’’. 

4 (k) PUBLICITY.—Section 705(b) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 375(b)) is amended 

6 by inserting ‘‘in vitro clinical tests,’’ after ‘‘devices,’’. 

7 (l) PRESUMPTION.—Section 709 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 379a) is amended by 

9 inserting ‘‘in vitro clinical test,’’ after ‘‘device,’’. 

10 (m) LISTING AND CERTIFICATION OF COLOR ADDI11 TIVES FOR FOODS, DRUGS, AND COSMETICS.—Section 

12 721(a) of the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 379e(a)) is amended— 

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

15 inserting ‘‘or in vitro clinical tests’’ after ‘‘or de16 vices’’; and 

17 (2) in the flush text following paragraph (2)— 

18 (A) by inserting ‘‘or an in vitro clinical 

19 test’’ after ‘‘a device’’; and 

20 (B) by inserting ‘‘or in vitro clinical tests’’ 

21 after ‘‘devices’’. 

22 (n) IMPORTS AND EXPORTS.—Section 801 of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 

24 is amended— 

25 (1) in subsection (a)— 


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1 (A) by inserting ‘‘in vitro clinical tests,’’ 

2 after ‘‘devices,’’ each place it appears; and 

3 (B) by inserting ‘‘in the case of an in vitro 

4 clinical test, the test does not conform to the 

5 applicable requirements of section 587K, or’’ 

6 after ‘‘requirements of section 520(f), or’’; 

7 (2) in subsection (d)(3)— 

8 (A) in subparagraph (A)— 

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

10 by inserting ‘‘and no component of an in 

11 vitro clinical test or other article of in vitro 

12 clinical test that requires further proc13 essing,’’ after ‘‘health-related purposes’’; 

14 (ii) in clause (i), by striking ‘‘drug or 

15 device’’ and inserting ‘‘drug, device, or in 

16 vitro clinical test’’; and 

17 (iii) in clause (i)(I), by inserting ‘‘in 

18 vitro clinical test,’’ after ‘‘device,’’; and 

19 (B) in subparagraph (B), by inserting ‘‘in 

20 vitro clinical test,’’ after ‘‘device,’’; 

21 (3) in subsection (e)(1), by inserting ‘‘in vitro 

22 clinical test,’’ after ‘‘device,’’; and 

23 (4) in subsection (o)— 

24 (A) by inserting ‘‘or in vitro clinical test’’ 

25 after ‘‘device’’; and 


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1 (B) by inserting ‘‘, or under section 587J 

2 of each foreign establishment,’’ after ‘‘section 

3 510(i) of 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 striking ‘‘, and’’ 

12 and inserting ‘‘and quality requirements estab13 lished under section 587K; and’’; 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 inserting ‘‘in vitro clin17 ical test developers,’’ after ‘‘device manufacturers,’’. 

18 (s) COUNTERMEASURE PROVISIONS OF THE PUBLIC

19 HEALTH SERVICE ACT.—Title III of the Public Health 

20 Service Act is amended— 

21 (1) in section 319F–1(a)(2)(A) (42 U.S.C. 

22 247d–6a(a)(2)(A))— 

23 (A) in the matter preceding clause (i)— 

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))),’’; and 

6 (B) in each of clauses (ii) and (iii), by 

7 striking ‘‘or device’’ and inserting ‘‘device, or in 

8 vitro clinical test’’; 

9 (2) in section 319F–2(c)(1)(B) (42 U.S.C. 

10 247d–6b(c)(1)(B))— 

11 (A) by striking ‘‘or device’’ and inserting 

12 ‘‘device’’; and 

13 (B) by inserting ‘‘, or an in vitro clinical 

14 test (as that term is defined in section 201(ss) 

15 of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 321(ss)))’’ after ‘‘Act (21 U.S.C. 

17 321(h))),’’; and 

18 (3) in section 319F–3(i)(7) (42 U.S.C. 247d– 

19 6d(i)(7))— 

20 (A) in the matter preceding subparagraph 

21 (A)— 

22 (i) by striking ‘‘or device’’ and insert23 ing ‘‘device’’; and 

24 (ii) by inserting ‘‘or an in vitro clin25 ical tests (as that term is defined in secVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00219 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 tion 201(ss) of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 321(ss))),’’ 

3 after ‘‘Act (21 U.S.C. 321(h))’’; 

4 (B) in subparagraph (A)— 

5 (i) by moving the margin of clause 

6 (iii) 2 ems to the left; and 

7 (ii) in clause (iii), by striking ‘‘or de8 vice’’ and inserting ‘‘device, or in vitro clin9 ical test’’; and 

10 (C) in subparagraph (B)— 

11 (i) in clause (i), by striking ‘‘approved 

12 or cleared’’ and inserting ‘‘approved, 

13 cleared, or offered under a technology cer14 tification order’’; and 

15 (ii) in clause (ii), by striking ‘‘or 

16 520(g)’’ and inserting ‘‘, 520(g), or 587S’’. 

17 SEC. 5. TRANSITION. 

18 (a) IMPLEMENTATION.— 

19 (1) EFFECTIVE DATE.— 

20 (A) IN GENERAL.—Except as otherwise 

21 provided in this section, the amendments made 

22 by this Act shall take effect on October 1, 2028 

23 (in this section and in subchapter J of chapter 

24 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 (2), and may expend such funds as the 

9 Secretary determines necessary to ensure 

10 an orderly transition prior to the effective 

11 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, 2028, 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, registers under 

23 such section 587J with respect to an arti24 cle that is an in vitro clinical test, such de25 veloper shall not be required to register 


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1 with respect to such article under section 

2 510 of the Federal Food, Drug, and Cos3 metic 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(i) of the Federal 

9 Food, Drug, and Cosmetic Act (as added 

10 by section 3); and 

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 (B) may take additional actions after the 

16 date of enactment that the Secretary deter17 mines necessary to ensure an orderly transition, 

18 including— 

19 (i) establishment of mitigating meas20 ures for an in vitro clinical test or category 

21 of in vitro clinical tests, which may not 

22 take effect until after the effective date de23 scribed in paragraph (1)(A); and 

24 (ii) establishment of the comprehen25 sive test information system under section 


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1 587T of the Federal Food, Drug, and Cos2 metic Act, as added by section 3. 

3 (3) APPLICABILITY OF GUIDANCE AND REGULA4 TIONS.—Notwithstanding the date on which guid5 ance or regulations are issued under paragraph (2) 

6 and section 587K of the Federal Food, Drug, and 

7 Cosmetic Act, as added by section 3, no guidance or 

8 regulations issued pursuant to the amendments 

9 made by this Act shall be implemented or take effect 

10 until the effective date of this Act, except as other11 wise specified in this Act (including the amendments 

12 made by this Act). 

13 (4) IMPLEMENTATION REQUIREMENTS.—In the 

14 event that the Secretary fails to promulgate the reg15 ulations required under section 587B(a)(4), 

16 587D(j), or 587S(b)(1) of the Federal Food, Drug, 

17 and Cosmetic Act, as added by section 3, by the 

18 deadline described in subsection (a)(2)(A)(ii), the 

19 Secretary shall, within 15 days of such missed dead20 line— 

21 (A) submit a report to the Committee on 

22 Health, Education, Labor, and Pensions of the 

23 Senate and the Committee on Energy and Com24 merce of the House of Representatives proVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00223 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 viding information related to the status of such 

2 regulations, including— 

3 (i) a rationale for missing the applica4 ble deadline described in such subsection; 

5 (ii) a description of actions taken to 

6 the date of submission of the report to pro7 mulgate each such regulations; 

8 (iii) the expected timeline for promul9 gating each such regulations; 

10 (iv) an assessment of the impact of 

11 the delay in promulgating such regulations 

12 on developers of in vitro clinical tests, in13 cluding an economic assessment; and 

14 (v) an assessment of the impact of the 

15 delay in promulgating such regulations on 

16 patients; and 

17 (B) open a public docket for purposes of 

18 soliciting public comments on the impact of the 

19 delay in promulgating such regulations. 

20 (b) APPLICATION OF AUTHORITIES TO IN VITRO

21 CLINICAL TESTS UNDER REVIEW ON THE EFFECTIVE

22 DATE OF THIS ACT.—For any in vitro clinical test for 

23 which a submission for approval under section 515 of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), 

25 clearance under section 510(k) of such Act (21 U.S.C. 


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1 360(k)), authorization under section 513(f)(2) of such Act 

2 (21 U.S.C. 360c(f)(2)), or licensure under section 351 of 

3 the Public Health Service Act (42 U.S.C. 262) is pending 

4 on the effective date of this Act, including transitional in 

5 vitro clinical tests as described in subsection (c), the Sec6 retary may review and take action on such submission 

7 after the effective date of this Act according to the statu8 tory provision under which such submission was sub9 mitted. 

10 (c) APPLICATION OF AUTHORITIES TO TRANSI11 TIONAL IN VITRO CLINICAL TESTS.— 

12 (1) DEFINITION.—For purposes of this section, 

13 the term ‘‘transitional in vitro clinical test’’ means 

14 an in vitro clinical test that— 

15 (A)(i) is first offered for clinical use during 

16 the period beginning on the date that is 45 

17 days after the date of enactment of this Act 

18 and ending on the effective date of this Act; or 

19 (ii) is offered solely for investigational use 

20 during the period beginning on the date of en21 actment of this Act and ending on the effective 

22 date of this Act; 

23 (B) is developed by a clinical laboratory 

24 certified by the Secretary under section 353 of 

25 the Public Health Service Act (42 U.S.C. 263a) 


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1 that meets the requirements for performing 

2 high-complexity testing and performed— 

3 (i) in the same clinical laboratory in 

4 which the test was developed and for which 

5 a certification is still in effect under such 

6 section 353 that meets the requirements to 

7 perform tests of high complexity; 

8 (ii) by another laboratory for which a 

9 certificate is in effect under such section 

10 353 that meets the requirements to per11 form tests of high complexity, is within the 

12 same corporate organization, and has com13 mon ownership by the same parent cor14 poration as the laboratory in which the 

15 test was developed; or 

16 (iii) in the case of a test that was de17 veloped by the Centers for Disease Control 

18 and Prevention or another laboratory in a 

19 public health laboratory network coordi20 nated or managed by the Centers for Dis21 ease Control and Prevention, by a clinical 

22 laboratory for which a certificate is in ef23 fect under such section 353 that meets the 

24 requirements to perform tests of high com25 plexity, and that is within a public health 


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1 laboratory network coordinated or man2 aged by the Centers for Disease Control 

3 and Prevention; and 

4 (C) when first offered, is not approved 

5 under section 515 of the Federal Food, Drug, 

6 and Cosmetic Act, cleared under section 510(k) 

7 of such Act, authorized under section 513(f)(2) 

8 of such Act, subject to a humanitarian device 

9 exemption under section 520(m) of such Act 

10 (21 U.S.C. 360j(m)), subject to an exemption 

11 for investigation use under section 520(g) of 

12 such Act (21 U.S.C. 360j(g)), authorized under 

13 section 564 of such Act (21 U.S.C. 360bbb–3), 

14 or licensed under section 351 of the Public 

15 Health Service Act (42 U.S.C. 262). 

16 (2) PREMARKET REVIEW OR TECHNOLOGY CER17 TIFICATION.—A transitional in vitro clinical test 

18 that is not exempt from premarket review under sec19 tion 587C of the Federal Food, Drug, and Cosmetic 

20 Act, as added by section 3, may continue to be of21 fered, sold, or distributed, as applicable, without 

22 marketing authorization until completion of the Sec23 retary’s review of the premarket application or tech24 nology certification application under section 587B 

25 or 587D, as applicable, if— 


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1 (A) such in vitro clinical test is a high-risk 

2 test (as defined in section 587 of the Federal 

3 Food, Drug, and Cosmetic Act, as added by 

4 section 3) and the application for such test is 

5 submitted not later than 90 days after the ef6 fective date of this Act; or 

7 (B) such in vitro clinical test is a mod8 erate-risk test (as defined in such section 587), 

9 the developer lists the test in accordance with 

10 section 587J within 10 calendar days of the ef11 fective date of this subchapter, and the applica12 tion for such test is submitted not later than 1 

13 year after the effective date of this Act. 

14 (3) INVESTIGATIONAL USE REQUEST.—A tran15 sitional in vitro clinical test described in paragraph 

16 (1)(A)(ii) that is used in a significant risk investiga17 tion may continue to be offered for investigational 

18 use until completion of the Secretary’s review of an 

19 application under 587S, if such application is sub20 mitted not later than 90 days after the effective date 

21 of this Act. 

22 (4) TESTS APPROVED BY NEW YORK STATE.— 

23 Notwithstanding paragraph (2), a transitional in 

24 vitro clinical test that has been approved by the New 

25 York State Department of Health may continue to 


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1 be offered, sold, or distributed, as applicable, after 

2 the effective date if— 

3 (A) starting on the effective date of this 

4 Act, the in vitro clinical test complies with the 

5 requirements of subchapter J of the Federal 

6 Food, Drug, and Cosmetic Act, as added by 

7 this Act, except for section 587B of the Federal 

8 Food, Drug, and Cosmetic Act, as added by 

9 section 3, and design control provisions of sec10 tion 587K of such Act; 

11 (B) each test report for the test bears a 

12 statement of adequate prominence that reads as 

13 follows: ‘‘This in vitro clinical test was devel14 oped and first introduced prior to the effective 

15 date of the VALID Act of 2023. This test was 

16 approved by the New York State Department of 

17 Health, but the test has not been reviewed by 

18 the Food and Drug Administration.’’; 

19 (C) a premarket application under section 

20 587B of the Federal Food, Drug, and Cosmetic 

21 Act, as added by section 3, or technology cer22 tification application under section 587D of 

23 such Act, as added by section 3, is submitted 

24 no later than— 


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1 (i) 5 years after the effective date of 

2 this Act, if the in vitro clinical test is ap3 proved by the New York State Department 

4 of Health as a genetic testing molecular 

5 test, a microbiology molecular test, an on6 cology molecular test, or any other type of 

7 molecular test; or 

8 (ii) 2 years after the effective date of 

9 this Act, if the in vitro clinical test is ap10 proved by the New York State Department 

11 of Health as a type of test not described 

12 in clause (i); and 

13 (D) a test in compliance with this para14 graph may continue to be offered, sold, or dis15 tributed, as applicable, until the completion of 

16 the Secretary’s review of the premarket applica17 tion or technology certification application de18 scribed in subparagraph (C). 

19 (d) CONVERSION.— 

20 (1) DEEMED PREMARKET APPROVAL.—Begin21 ning on the effective date of this Act— 

22 (A) any in vitro clinical test with a pre23 market approval under section 515 of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

25 360e) or a licensure under section 351 of the 


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1 Public Health Service Act (42 U.S.C. 262) is 

2 deemed to be approved pursuant to an applica3 tion under section 587B(a) of the Federal 

4 Food, Drug, and Cosmetic Act, as added by 

5 this Act; and 

6 (B) any in vitro clinical test (as so defined) 

7 that was cleared under section 510(k) of the 

8 Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 360(k)) or authorized under section 

10 513(f)(2) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 360c(f)(2)) is deemed to 

12 be approved pursuant to an application under 

13 section 587B(b) of the Federal Food, Drug, 

14 and Cosmetic Act, as added by this Act. 

15 (2) DEEMED INVESTIGATIONAL USE EXEMP16 TION.—Any in vitro clinical test that has an inves17 tigational device exemption in effect under section 

18 520(g) of the Federal Food, Drug, and Cosmetic Act 

19 (21 U.S.C. 360j(g)) is deemed to have an investiga20 tional use exemption in effect under section 587S of 

21 such Act, as added by this Act, beginning on the ef22 fective date of this Act. 

23 (3) DEEMED HUMANITARIAN DEVICE EXEMP24 TION.—Any in vitro clinical test that has an ap25 proved humanitarian device exemption under section 


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1 520(m) of such Act is deemed to have a humani2 tarian test exemption under section 587A(g) of such 

3 Act, as added by this Act, beginning on the effective 

4 date of this Act. 

5 (4) DEEMED DESIGNATED BREAKTHROUGH.— 

6 Any in vitro clinical test that has received a break7 through device designation under section 

8 515B(e)(1)(D) of such Act (21 U.S.C. 360e– 

9 3(e)(1)(D)) is deemed to have a breakthrough in 

10 vitro clinical test designation under section 587C of 

11 such Act, as added by this Act, beginning on the ef12 fective date of this Act. 

13 (5) DEEMED REQUEST FOR INFORMAL FEED14 BACK.—With regard to any in vitro clinical test that 

15 is the subject of a pre-submission request described 

16 in the guidance, ‘‘Requests for Feedback and Meet17 ings for Medical Device Submissions: The Q–Sub18 mission Program’’, issued by the Food and Drug 

19 Administration on January 6, 2021, such request is 

20 deemed to constitute a request for informal feedback 

21 under section 587F of the Federal Food, Drug, and 

22 Cosmetic Act, as added by section 3, beginning on 

23 the effective date of this Act. 

24 (e) PREVIOUSLY CLASSIFIED DEVICES.—Notwith25 standing section 587 of the Federal Food, Drug, and CosVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00232 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 metic Act, as added by section 3, for purposes of sub2 chapter J of chapter V of such Act, as added by section 

3 3, the following apply: 

4 (1) In the case of an in vitro clinical test type 

5 that has been classified by the Secretary as a class 

6 I device pursuant to section 513 of such Act (21 

7 U.S.C. 360c), such in vitro clinical test shall be low8 risk, unless the in vitro clinical test is a test de9 scribed in the second sentence of section 510(l)(1) of 

10 such Act or the test is redesignated by the Secretary 

11 pursuant to section 587F of such Act. 

12 (2) In the case of an in vitro clinical test type 

13 that has been classified by the Secretary as a class 

14 II device pursuant to section 513 of such Act (21 

15 U.S.C. 360c), such in vitro clinical test shall be 

16 moderate-risk, unless inaccurate results from the 

17 test would be immediately life threatening or the test 

18 is redesignated by the Secretary pursuant to section 

19 587F of such Act. 

20 (3) In the case of an in vitro clinical test type 

21 that has been classified by the Secretary as a class 

22 III device pursuant to section 513 of such Act (21 

23 U.S.C. 360c) or an in vitro clinical test licensed pur24 suant to section 351 of the Public Health Service 

25 Act (42 U.S.C. 262), such in vitro clinical test shall 


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1 be high-risk, unless redesignated by the Secretary 

2 pursuant to section 587F of the Federal Food, 

3 Drug, and Cosmetic Act. 

4 SEC. 6. EMERGENCY USE AUTHORIZATION. 

5 (a) IN GENERAL.—Section 564 of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend7 ed— 

8 (1) by inserting ‘‘or developer’’ after ‘‘manufac9 turer’’, each place such term appears; 

10 (2) 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 (B) in paragraph (2)(A), by striking ‘‘or 

15 515’’ and inserting ‘‘515, or 587B’’; and 

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

17 ‘‘(F) The terms ‘develop’ and ‘developer’, 

18 with respect to an in vitro clinical test, have the 

19 meanings given such terms in section 587.’’; 

20 (3) in subsection (b), by inserting ‘‘or devel21 oper’’ after ‘‘manufacturer’’ each place such term 

22 appears; 

23 (4) in subsection (e)— 

24 (A) by inserting ‘‘or developers’’ after 

25 ‘‘manufacturers’’ each place such term appears; 


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1 (B) in paragraph (2)(B)(ii), by inserting 

2 ‘‘or develop’’ after ‘‘not manufacture’’; 

3 (C) in paragraph (3)— 

4 (i) in subparagraph (A), by striking 

5 ‘‘or 520(f)(1)’’ and inserting ‘‘, 520(f)(1), 

6 or 587V’’; 

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

8 ‘‘and’’ at the end; 

9 (iii) in subparagraph (C), by striking 

10 the period and inserting ‘‘ or 587O; and’’; 

11 and 

12 (iv) by adding at the end the fol13 lowing: 

14 ‘‘(D) quality requirements (with respect to 

15 in vitro clinical tests) under section 587K.’’; 

16 and 

17 (D) in paragraph (4)— 

18 (i) in subparagraph (A), by striking ‘‘; 

19 or’’ and inserting a semicolon; 

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

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

22 (iii) by adding at the end the fol23 lowing: 


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1 ‘‘(C) with respect to in vitro clinical tests, 

2 requirements applicable to restricted in vitro 

3 clinical tests pursuant to section 587O.’’; 

4 (5) in subsection (k), by striking ‘‘or 520(g)’’ 

5 and inserting ‘‘520(g), or 587S’’; and 

6 (6) in subsection (m)— 

7 (A) in the subsection heading, by striking 

8 ‘‘LABORATORY TESTS ASSOCIATED WITH DE9 VICES’’ inserting ‘‘IN VITRO CLINICAL TESTS’’ 

10 after ‘‘DEVICES’’; and 

11 (B) in paragraph (1)— 

12 (i) by striking ‘‘to a device’’ and in13 serting ‘‘to an in vitro clinical test’’; and 

14 (ii) by striking ‘‘such device’’ and in15 serting ‘‘such in vitro clinical test’’. 

16 (b) EMERGENCY USE OF MEDICAL PRODUCTS.—Sec17 tion 564A of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 360bbb–3a) is amended— 

19 (1) in subsection (a)— 

20 (A) in paragraph (2), by inserting ‘‘in vitro 

21 clinical test,’’ after ‘‘device,’’; and 

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

23 ‘‘(3) DEVELOPER.—The term ‘developer’, with 

24 respect to an in vitro clinical test, has the meaning 

25 given such term in section 587.’’; 


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1 (2) by inserting ‘‘or developer’’ after ‘‘manufac2 turer’’ each place it appears; and 

3 (3) in subsection (c)(1)— 

4 (A) by inserting ‘‘or quality requirements’’ 

5 after ‘‘good manufacturing practice require6 ments’’; and 

7 (B) by striking ‘‘or 520(f)(1)’’ and insert8 ing ‘‘, 520(f)(1), or 587K’’. 

9 (c) PRODUCTS HELD FOR EMERGENCY USE.—Sec10 tion 564B(2) of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 360bbb–3b(2)) is amended— 

12 (1) in subparagraph (A), by striking ‘‘or 515’’ 

13 and inserting ‘‘515, or 587B’’; and 

14 (2) in subparagraph (B), by striking ‘‘or 520’’ 

15 and inserting 520, or 587S. 

16 SEC. 7. ANTIMICROBIAL SUSCEPTIBILITY TESTS. 

17 Section 511A of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 360a–2) is amended— 

19 (1) in subsection (a)(1)(C)— 

20 (A) by striking ‘‘clear under section 

21 510(k), classify under section 513(f)(2), or ap22 prove under section 515’’ and inserting ‘‘ap23 prove under section 587B, exempt from pre24 market review under section 587C, or grant a 


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1 technology certification order under section 

2 587D’’; and 

3 (B) by striking ‘‘testing devices’’ and in4 serting ‘‘in vitro clinical tests’’; 

5 (2) in subsection (c)(5)— 

6 (A) by striking ‘‘drug or device’’ and in7 serting ‘‘drug, device, or in vitro clinical test’’; 

8 and 

9 (B) by striking ‘‘the drug or the device’’ 

10 and inserting ‘‘the drug, device, or in vitro clin11 ical test’’; 

12 (3) in subsection (e)— 

13 (A) in the heading, by striking ‘‘TESTING

14 DEVICES’’ and inserting ‘‘IN VITRO CLINICAL

15 TESTS’’; 

16 (B) in paragraph (1)— 

17 (i) by striking ‘‘510, 513, and 515,’’ 

18 and inserting ‘‘587B, and 587D’’; 

19 (ii) by striking ‘‘antimicrobial suscep20 tibility testing device’’ and inserting ‘‘anti21 microbial susceptibility in vitro clinical 

22 test’’; and 

23 (iii) by striking ‘‘such device’’ and in24 serting ‘‘such in vitro clinical test’’; and 

25 (C) in paragraph (2)— 


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1 (i) in the heading, by striking ‘‘TEST2 ING DEVICES’’ and inserting ‘‘IN VITRO

3 CLINICAL TESTS’’; 

4 (ii) in subparagraphs (A) and (B) 

5 (other than clause (iii) of such subpara6 graph (B)), by striking ‘‘device’’ each place 

7 it appears and inserting ‘‘in vitro clinical 

8 test’’; 

9 (iii) in subparagraph (B)(iii), by strik10 ing ‘‘a device’’ and inserting ‘‘an in vitro 

11 clinical test’’; and 

12 (iv) by amending subparagraph (C) to 

13 read as follows: 

14 ‘‘(C) The antimicrobial susceptibility in 

15 vitro clinical test meets all other requirements 

16 to be approved under section 587B, to be ex17 empted from premarket review under section 

18 587C, or to be offered under a technology cer19 tification order under section 587D.’’; 

20 (4) in subsection (f), by amending paragraph 

21 (1) to read as follows: 

22 ‘‘(1) The term ‘antimicrobial susceptibility in 

23 vitro clinical test’ means an in vitro clinical test that 

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1 termine and report the in vitro susceptibility of cer2 tain microorganisms to a drug (or drugs).’’; and 

3 (5) in subsection (g)(2)— 

4 (A) by amending the matter preceding sub5 paragraph (A) to read as follows: 

6 ‘‘(2) with respect to approving an application 

7 under section 587B or granting a technology certifi8 cation order under section 587D—’’; and 

9 (B) in subparagraph (A)— 

10 (i) by striking ‘‘device’’ and inserting 

11 ‘‘in vitro clinical test’’; and 

12 (ii) by striking ‘‘antimicrobial suscep13 tibility testing device’’ and inserting ‘‘anti14 microbial susceptibility in vitro clinical 

15 test’’. 

16 SEC. 8. COMBINATION PRODUCTS. 

17 (a) IN GENERAL.—Section 503(g) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is 

19 amended— 

20 (1) in paragraph (1)— 

21 (A) in subparagraph (A), by striking ‘‘or 

22 biological product’’ and inserting ‘‘in vitro clin23 ical test (except for a product constituted of a 

24 device and an in vitro clinical test), or biological 

25 product’’; 


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1 (B) in subparagraph (B), by adding at the 

2 end the following: ‘‘For purposes of this Act, a 

3 product that constitutes a combination of a de4 vice and an in vitro clinical test is not a com5 bination product within the meaning of this 

6 subsection and an in vitro clinical test that is 

7 offered as a separate product intended to in8 form the use of a drug, biological product, or 

9 device is not a combination product within the 

10 meaning of this subsection.’’; and 

11 (C) in subparagraph (D)(ii)— 

12 (i) by inserting ‘‘or in vitro clinical 

13 test’’ after ‘‘device’’; and 

14 (ii) by inserting ‘‘and in vitro clinical 

15 tests’’ before ‘‘shall’’; 

16 (2) in paragraph (3), by striking ‘‘safety and 

17 effectiveness or substantial equivalence’’ and insert18 ing ‘‘safety and effectiveness, substantial equiva19 lence, or analytical validity and clinical validity’’ be20 fore ‘‘for the approved constituent part’’; 

21 (3) in paragraph (4)— 

22 (A) in subparagraph (A), by striking ‘‘or 

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1 mitted in accordance with paragraph (5)), 

2 587B, or 587D’’; and 

3 (B) in subparagraph (C), by striking ‘‘or 

4 515’’ and inserting ‘‘515, or 587B, or that is 

5 under an order under section 587D’’; 

6 (4) in paragraph (5)(A), by striking ‘‘or 

7 510(k)’’ and inserting ‘‘, 510(k), 587B, or 587D’’; 

8 (5) in paragraph (7), by striking ‘‘or substan9 tial equivalence’’ and inserting ‘‘, substantial equiva10 lence, or analytical validity and clinical validity’’; 

11 (6) in paragraph (8), by adding at the end the 

12 following: 

13 ‘‘(I) This paragraph shall not apply to a 

14 product constituted of a device and an in vitro 

15 clinical test.’’; and 

16 (7) in paragraph (9)— 

17 (A) in subparagraph (C)(i), by striking ‘‘or 

18 520(g)’’ and inserting ‘‘520(g), 587B, or 

19 587D’’; and 

20 (B) in subparagraph (D), by striking ‘‘or 

21 520’’ and inserting ‘‘520, 587B, or 587D’’. 

22 (b) CLASSIFICATION OF PRODUCTS.—Section 563 of 

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

24 360bbb–2) is amended by adding at the end the following: 


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1 ‘‘(d) EXEMPTION.—This section shall not apply to a 

2 product constituted of only a device and an in vitro clinical 

3 test.’’. 

4 SEC. 9. RESOURCES. 

5 (a) FINDINGS.—Congress finds that the fees author6 ized by this section will be dedicated to meeting the goals 

7 identified in the letters from the Secretary of Health and 

8 Human Services to the Committee on Health, Education, 

9 Labor, and Pensions of the Senate and the Committee on 

10 Energy and Commerce of the House of Representatives, 

11 as set forth in the Congressional Record. 

12 (b) ESTABLISHMENT OF USER FEE PROGRAM.— 

13 (1) DEVELOPMENT OF USER FEES FOR IN

14 VITRO CLINICAL TESTS.— 

15 (A) IN GENERAL.—Beginning not later 

16 than October 1, 2025, the Secretary of Health 

17 and Human Services (in this section referred to 

18 as the ‘‘Secretary’’) shall initiate the develop19 ment of recommendations in accordance with 

20 this section to present to Congress with respect 

21 to the goals, and plans for meeting the goals, 

22 for the process for the review of in vitro clinical 

23 test submissions and applications under sub24 chapter J of chapter V of the Federal Food, 

25 Drug, and Cosmetic Act, as added by this Act, 


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1 for the first 4 fiscal years after fiscal year 2028 

2 and for the authorization of the In Vitro Clin3 ical Test User Fee Program for such fiscal 

4 years. In developing such recommendations, the 

5 Secretary shall consult with— 

6 (i) the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate; 

8 (ii) the Committee on Energy and 

9 Commerce of the House of Representa10 tives; 

11 (iii) scientific and academic experts; 

12 (iv) health care professionals; 

13 (v) representatives of patient and con14 sumer advocacy groups; and 

15 (vi) the regulated industry. 

16 (B) PRIOR PUBLIC INPUT.—Prior to begin17 ning negotiations with the regulated industry 

18 on the authorization of the In Vitro Clinical 

19 Test User Fee Program, as described in this 

20 section, the Secretary shall— 

21 (i) publish a notice in the Federal 

22 Register requesting public input on the au23 thorization of user fees; 

24 (ii) hold a public meeting at which the 

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1 ization, including specific suggestions for 

2 the recommendations submitted under sub3 paragraph (E); 

4 (iii) provide a period of 30 days after 

5 the public meeting to obtain written com6 ments from the public suggesting changes 

7 to the In Vitro Clinical Test User Fee Pro8 gram; and 

9 (iv) publish any comments received 

10 under clause (iii) on the website of the 

11 Food and Drug Administration. 

12 (C) PERIODIC CONSULTATION.—Not less 

13 frequently than once every month during nego14 tiations with the regulated industry, the Sec15 retary shall hold discussions with representa16 tives of patient and consumer advocacy groups 

17 to continue discussions of the authorization of 

18 the In Vitro Clinical Test User Fee Program 

19 and to solicit suggestions to be included in the 

20 recommendations transmitted to Congress 

21 under subparagraph (F). 

22 (D) UPDATES TO CONGRESS.—The Sec23 retary, in consultation with regulated industry, 

24 shall provide regular updates on negotiations on 

25 the reauthorization of the In Vitro Clinical Test 


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1 User Fee Program to the Committee on Health, 

2 Education, Labor, and Pensions of the Senate 

3 and the Committee on Energy and Commerce 

4 of the House of Representatives. 

5 (E) PUBLIC REVIEW OF RECOMMENDA6 TIONS.—After negotiations with the regulated 

7 industry, the Secretary shall— 

8 (i) present the recommendations de9 veloped under subparagraph (A) to the 

10 Committee on Health, Education, Labor, 

11 and Pensions of the Senate and the Com12 mittee on Energy and Commerce of the 

13 House of Representatives; 

14 (ii) publish such recommendations in 

15 the Federal Register; 

16 (iii) provide for a period of 30 days 

17 for the public to provide written comments 

18 on such recommendations; 

19 (iv) hold a meeting at which the pub20 lic may present its views on such rec21 ommendations; and 

22 (v) after consideration of such public 

23 views and comments, revise such rec24 ommendations as necessary. 


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1 (F) TRANSMITTAL OF RECOMMENDA2 TIONS.— 

3 (i) IN GENERAL.—Not later than Jan4 uary 15, 2027, the Secretary shall trans5 mit to Congress the revised recommenda6 tions under subparagraph (A), a summary 

7 of the views and comments received under 

8 such subparagraph, and any changes made 

9 to the recommendations in response to 

10 such views and comments. 

11 (ii) RECOMMENDATION REQUIRE12 MENTS.—The recommendations trans13 mitted under this subparagraph shall— 

14 (I) include the number of full15 time equivalent employees per fiscal 

16 year that are agreed to be hired to 

17 carry out the goals included in such 

18 recommendations for each year of the 

19 5-year period; 

20 (II) provide that the amount of 

21 operating reserve balance in the user 

22 fee program established under this 

23 section is not more than the equiva24 lent of 10 weeks of operating reserve; 


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1 (III) require the development of 

2 a strategic plan for any surplus within 

3 the operating reserve account above 

4 the 10-week operating reserve within 

5 2 years of the establishment of the 

6 program; 

7 (IV) include an operating reserve 

8 adjustment such that, if the Secretary 

9 has an operating reserve balance in 

10 excess of 10 weeks of such operating 

11 reserves, the Secretary shall decrease 

12 such fee revenue and fees to provide 

13 for not more than 10 weeks of such 

14 operating reserves; 

15 (V) if an adjustment is made as 

16 described in subclause (IV), provide 

17 the rationale for the amount of the 

18 decrease in fee revenue and fees shall 

19 be contained in the Federal Register; 

20 and 

21 (VI) provide that the fees as22 sessed and collected for the full-time 

23 equivalent employees at the Center for 

24 Devices and Radiological Health, with 

25 respect to which the majority of time 


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1 reporting data indicates are dedicated 

2 to the process for the review of in 

3 vitro clinical test submissions and ap4 plications under paragraph (5), are 

5 not supported by the funds authorized 

6 to be collected and assessed under sec7 tion 738 of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 379j). 

9 (G) PUBLICATION OF RECOMMENDA10 TIONS.—The Secretary shall publish on the 

11 website of the Food and Drug Administration 

12 the revised recommendations under subpara13 graph (F), a summary of the recommendations, 

14 views, and comments received under subpara15 graphs (B), (C), and (E), and any changes 

16 made to the recommendations originally pro17 posed by the Secretary in response to such rec18 ommendations, views, and comments. 

19 (H) MINUTES OF NEGOTIATION MEET20 INGS.— 

21 (i) PUBLIC AVAILABILITY.—The Sec22 retary shall make publicly available, on the 

23 website of the Food and Drug Administra24 tion, minutes of all negotiation meetings 

25 conducted under this subsection between 


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1 the Food and Drug Administration and the 

2 regulated industry not later than 30 days 

3 after such meeting. 

4 (ii) CONTENT.—The minutes de5 scribed under clause (i) shall summarize 

6 any substantive proposal made by any 

7 party to the negotiations, any significant 

8 controversies or differences of opinion dur9 ing the negotiations, and the resolution of 

10 any such controversy or difference of opin11 ion. 

12 (2) ESTABLISHMENT OF USER FEE PRO13 GRAM.—Effective on October 1, 2028, provided that 

14 the Secretary transmits the recommendations under 

15 paragraph (1)(F), the Secretary is authorized to col16 lect user fees relating to the review of in vitro clin17 ical test submissions and applications submitted 

18 under subchapter J of chapter V of the Federal 

19 Food, Drug, and Cosmetic Act, as added by this 

20 Act, and any other activities or goals included in rec21 ommendations transmitted to Congress pursuant to 

22 this subsection. Fees under such program shall be 

23 assessed and collected only if the requirements under 

24 paragraph (4) are met. 

25 (3) AUDIT.— 


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1 (A) IN GENERAL.—Beginning 2 years after 

2 first receiving a user fee applicable to submis3 sion of an in vitro clinical test application sub4 mitted under subchapter J of chapter V of the 

5 Federal Food, Drug, and Cosmetic Act, as 

6 added by this Act, the Secretary shall, on a bi7 ennial basis, perform an audit of the costs of 

8 reviewing such applications and any other ac9 tivities under such subchapter J included in 

10 recommendations transmitted to Congress pur11 suant to this subsection. Such an audit shall 

12 compare the costs of reviewing such applica13 tions and other activities under such subchapter 

14 J to the amount of the user fee applicable to 

15 such applications and make any necessary ad16 justments as described in subparagraph (B). 

17 (B) ALTERATION OF USER FEE.—The fol18 lowing adjustments shall apply with respect to 

19 audits performed under subparagraph (A): 

20 (i) If the audit performed 2 years 

21 after first receiving a user fee applicable to 

22 submission of an in vitro clinical test appli23 cation described under subparagraph (A) 

24 indicates that the user fees collected for 

25 purposes of such subchapter J exceed 33 


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1 percent of the costs of reviewing such ap2 plications and carrying out activities in3 cluded in recommendations transmitted to 

4 Congress pursuant to this subsection, the 

5 Secretary shall alter the user fees applica6 ble to applications submitted under such 

7 subchapter J such that the user fees do 

8 not exceed such percentage. 

9 (ii) If the audit performed 6 years 

10 after first receiving a user fee applicable to 

11 submission of an in vitro clinical test appli12 cation described under subparagraph (A) 

13 indicates that the user fees collected for 

14 purposes of such subchapter J exceed 40 

15 percent of the costs of reviewing such ap16 plications, and carrying out activities in17 cluded in recommendations transmitted to 

18 Congress pursuant to this subsection, the 

19 Secretary shall alter the user fees applica20 ble to applications submitted under such 

21 subchapter J such that the user fees do 

22 not exceed such percentage. 

23 (iii) If the audit performed 12 years 

24 after first receiving a user fee applicable to 

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1 cation described under subparagraph (A), 

2 and any audit performed after such date, 

3 indicates that the user fees collected for 

4 purposes of such subchapter J exceed 49 

5 percent of the costs of reviewing such ap6 plications, and carrying out activities in7 cluded in recommendations transmitted to 

8 Congress pursuant to this subsection, the 

9 Secretary shall alter the user fees applica10 ble to applications submitted under such 

11 subchapter J such that the user fees do 

12 not exceed such percentage. 

13 (C) ACCOUNTING STANDARDS.—The Sec14 retary shall perform an audit under subpara15 graph (A) in conformance with the accounting 

16 principles, standards, and requirements pre17 scribed by the Comptroller General of the 

18 United States under section 3511 of title 31, 

19 United States Code, to ensure the validity of 

20 any potential variability. 

21 (D) IMPLEMENTATION REQUIREMENTS.— 

22 In the event that the Secretary fails to promul23 gate the regulations described in section 

24 587B(a)(4), 587D(j), or 587S(b)(1) of the Fed25 eral Food, Drug, and Cosmetic Act, as added 


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1 by section 3, by the applicable deadline for each 

2 such regulations as described in section 

3 5(a)(2)(A)(ii), the Secretary shall provide that 

4 the user fees applicable to applications sub5 mitted under subchapter J of chapter V of the 

6 Federal Food, Drug, and Cosmetic Act, as 

7 added by section 3, do not exceed 30 percent of 

8 the costs of reviewing such applications. 

9 (4) CONDITIONS.—The user fee program de10 scribed in this subsection shall take effect only if the 

11 Food and Drug Administration issues a regulation 

12 related to the review requirements for in vitro diag13 nostic tests that would be subject to premarket re14 view under section 587B of the Federal Food, Drug, 

15 and Cosmetic Act, as added by section 3, the review 

16 requirements for test categories eligible for tech17 nology certification under section 587D of such Act, 

18 as added by section 3, and the parameters for the 

19 test categories that would be exempt from any re20 view under subchapter J of chapter V of such Act. 

21 (5) USER FEE PROGRAM DEFINITIONS AND RE22 SOURCE REQUIREMENTS.— 

23 (A) IN GENERAL.—The term ‘‘process for 

24 the review of in vitro clinical test submissions 

25 and applications’’ means the following activities 


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1 of the Secretary with respect to the review of in 

2 vitro clinical test premarket and technology cer3 tification applications including supplements for 

4 such applications: 

5 (i) The activities necessary for the re6 view of premarket applications, premarket 

7 reports, technology certification applica8 tions, and supplements to such applica9 tions. 

10 (ii) Actions related to submissions in 

11 connection with in vitro clinical test devel12 opment, the issuance of action letters that 

13 allow the marketing of in vitro clinical 

14 tests or which set forth in detail the spe15 cific deficiencies in such applications, re16 ports, supplements, or submissions and, 

17 where appropriate, the actions necessary to 

18 support the development of in vitro clinical 

19 tests. 

20 (iii) The inspection of manufacturing 

21 establishments and other facilities under22 taken as part of the Secretary’s review of 

23 pending premarket applications, technology 

24 certifications, and supplements. 


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1 (iv) Monitoring of research conducted 

2 in connection with the review of such appli3 cations, supplements, and submissions. 

4 (v) Review of in vitro clinical test ap5 plications subject to section 351 of the 

6 Public Health Service Act (42 U.S.C. 262) 

7 and activities conducted in anticipation of 

8 the submission of such applications for in9 vestigational use under section 587S of the 

10 Federal Food, Drug, and Cosmetic Act (as 

11 added by section 3). 

12 (vi) The development of guidance, pol13 icy documents, or regulations to improve 

14 the process for the review of premarket ap15 plications, technology certification applica16 tions, and supplements. 

17 (vii) The development of voluntary 

18 test methods, consensus standards, or 

19 mandatory performance standards in con20 nection with the review of such applica21 tions, supplements, or submissions and re22 lated activities. 

23 (viii) The provision of technical assist24 ance to in vitro clinical test developers in 

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1 plications, reports, supplements, or submis2 sions. 

3 (ix) Any activity undertaken in con4 nection with the initial classification or re5 classification of an in vitro clinical test in 

6 connection with any requirement for ap7 proval or eligibility for an exemption from 

8 premarket review of an in vitro clinical 

9 test. 

10 (x) Any activity undertaken in connec11 tion with making a pathway determination 

12 of an in vitro clinical test, including the 

13 identification, establishment, and imple14 mentation of mitigation measures. 

15 (xi) Evaluation of postmarket studies 

16 required as a condition of an approval of 

17 a premarket application of an in vitro clin18 ical test and ensuring such studies are con19 ducted as required. 

20 (xii) Any activity undertaken in con21 nection with ensuring in vitro clinical tests 

22 offered under an exemption from pre23 market review pursuant to section 587C or 

24 587G meet the criteria for such exemption 

25 and the applicable standard. 


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1 (xiii) Compiling, developing, and re2 viewing information on in vitro clinical 

3 tests necessary to identify issues with the 

4 ability of in vitro clinical tests to meet the 

5 applicable standard, as applicable. 

6 (B) RESOURCE REQUIREMENTS.—Fees col7 lected and assessed under this section shall be 

8 used for the process for the review of in vitro 

9 clinical test applications, as described in sub10 paragraph (A), and shall— 

11 (i) be subject to the limitation under 

12 section 738(g)(3) of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 

14 379j(g)(3)), in the same manner that fees 

15 collected and assessed under section 

16 737(9)(C) of such Act (21 U.S.C. 

17 379i(9)(C)) are subject to such limitation; 

18 (ii) include travel expenses for officers 

19 and employees of the Food and Drug Ad20 ministration only if the Secretary deter21 mines that such travel is directly related to 

22 an activity described in subparagraph (A); 

23 and 

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1 solidated Appropriations Act, 2018 (Public 

2 Law 115–141). 

3 (c) REPORTS.— 

4 (1) PERFORMANCE REPORT.— 

5 (A) IN GENERAL.— 

6 (i) GENERAL REQUIREMENTS.—Be7 ginning with fiscal year 2028, for each fis8 cal year for which fees are collected under 

9 this section, the Secretary shall prepare 

10 and submit to the Committee on Health, 

11 Education, Labor, and Pensions of the 

12 Senate and the Committee on Energy and 

13 Commerce of the House of Representatives 

14 annual reports concerning the progress of 

15 the Food and Drug Administration in 

16 achieving the goals identified in the rec17 ommendations transmitted to Congress by 

18 the Secretary pursuant to subsection 

19 (b)(1)(F) during such fiscal year and the 

20 future plans of the Food and Drug Admin21 istration for meeting the goals. 

22 (ii) ADDITIONAL INFORMATION.—Be23 ginning with fiscal year 2028, the annual 

24 report under this subparagraph shall in25 clude the progress of the Food and Drug 


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1 Administration in achieving the goals, and 

2 future plans for meeting the goals, includ3 ing— 

4 (I) the number of premarket ap5 plications filed under section 587B of 

6 the Federal Food, Drug, and Cos7 metic Act during the applicable fiscal 

8 year; 

9 (II) the number of technology 

10 certification applications submitted 

11 under section 587D of the Federal 

12 Food, Drug, and Cosmetic Act during 

13 the applicable fiscal year for each re14 view division; 

15 (III) the number of breakthrough 

16 designations under section 587I of the 

17 Federal Food, Drug, and Cosmetic 

18 Act during the applicable fiscal year; 

19 and 

20 (IV) the number of information 

21 requests requested by the Secretary 

22 pursuant to section 587G(d) of such 

23 Act. 

24 (iii) REAL-TIME REPORTING.— 


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1 (I) IN GENERAL.—Not later than 

2 30 calendar days after the end of the 

3 second quarter of fiscal year 2028, 

4 and not later than 30 calendar days 

5 after the end of each quarter of each 

6 fiscal year thereafter, the Secretary 

7 shall post the data described in sub8 clause (II) on the website of the Food 

9 and Drug Administration for such 

10 quarter and on a cumulative basis for 

11 such fiscal year, and may remove du12 plicative data from the annual report 

13 under this subparagraph. 

14 (II) DATA.—The Secretary shall 

15 post the following data in accordance 

16 with subclause (I): 

17 (aa) The number and titles 

18 of draft and final regulations on 

19 topics related to the process for 

20 the review of in vitro clinical test 

21 submissions and applications, 

22 and whether such regulations 

23 were required by statute or pur24 suant to the recommendations 

25 transmitted to Congress by the 


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1 Secretary pursuant to subsection 

2 (b)(1)(F). 

3 (bb) The number and titles 

4 of draft and final guidance on 

5 topics related to the process for 

6 the review of in vitro clinical test 

7 submissions and applications, 

8 and whether such guidances were 

9 issued as required by statute or 

10 pursuant to the recommendations 

11 transmitted to Congress by the 

12 Secretary pursuant to subsection 

13 (b)(1)(F). 

14 (cc) The number and titles 

15 of public meetings held on topics 

16 related to the process for the re17 view of in vitro clinical tests, and 

18 if such meetings were required by 

19 statute or pursuant to the rec20 ommendations transmitted to 

21 Congress by the Secretary pursu22 ant to subsection (b)(1)(F). 

23 (iv) RATIONALE FOR IVCT USER FEE

24 PROGRAM CHANGES.—Beginning with fis25 cal year 2028, the Secretary shall include 


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1 in the annual performance report under 

2 paragraph (1)— 

3 (I) data, analysis, and discussion 

4 of the changes in the number of indi5 viduals hired as agreed upon in the 

6 recommendations transmitted to Con7 gress by the Secretary pursuant to 

8 subsection (b)(1)(F) and the number 

9 of remaining vacancies, the number of 

10 full-time equivalents funded by fees 

11 collected pursuant to this section, and 

12 the number of full-time equivalents 

13 funded by budget authority at the 

14 Food and Drug Administration by 

15 each division within the Center for 

16 Devices and Radiological Health, the 

17 Center for Biologics Evaluation and 

18 Research, the Office of Regulatory Af19 fairs, and the Office of the Commis20 sioner; 

21 (II) data, analysis, and discus22 sion of the changes in the fee revenue 

23 amounts and costs for the process for 

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1 missions and applications, including 

2 identifying— 

3 (aa) drivers of such changes; 

4 and 

5 (bb) changes in the average 

6 total cost per full-time equivalent 

7 in the in vitro clinical test review 

8 program; 

9 (III) for each of the Center for 

10 Devices and Radiological Health, the 

11 Center for Biologics Evaluation and 

12 Research, the Office of Regulatory Af13 fairs, and the Office of the Commis14 sioner, the number of employees for 

15 whom time reporting is required and 

16 the number of employees for whom 

17 time reporting is not required; and 

18 (IV) data, analysis, and discus19 sion of the changes in the average 

20 full-time equivalent hours required to 

21 complete review of each type of in 

22 vitro clinical test application. 

23 (v) ANALYSIS.—For each fiscal year, 

24 the Secretary shall include in the report 


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1 under clause (i) an analysis of the fol2 lowing: 

3 (I) The difference between the 

4 aggregate number of premarket appli5 cations filed under section 587B or 

6 section 587D of the Federal Food, 

7 Drug, and Cosmetic Act and the ag8 gregate number of major deficiency 

9 letters, not approvable letters, and de10 nials for such applications issued by 

11 the agency, accounting for— 

12 (aa) the number of applica13 tions filed under each of sections 

14 587B and 587D of the Federal 

15 Food, Drug, and Cosmetic Act 

16 during one fiscal year for which a 

17 decision is not scheduled to be 

18 made until the following fiscal 

19 year; and 

20 (bb) the aggregate number 

21 of applications under each of sec22 tions 587B and 587D of the 

23 Federal Food, Drug, and Cos24 metic Act for each fiscal year 

25 that did not meet the goals as 


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1 identified by the recommenda2 tions transmitted to Congress by 

3 the Secretary pursuant to sub4 section (b)(1)(F). 

5 (II) Relevant data to determine 

6 whether the Center for Devices and 

7 Radiological Health has met perform8 ance enhancement goals identified by 

9 the recommendations transmitted to 

10 Congress by the Secretary pursuant to 

11 subsection (b)(1)(F). 

12 (III) The most common causes 

13 and trends for external or other cir14 cumstances affecting the ability of the 

15 Food and Drug Administration to 

16 meet review time and performance en17 hancement goals identified by the rec18 ommendations transmitted to Con19 gress by the Secretary pursuant to 

20 subsection (b)(1)(F). 

21 (B) PUBLICATION.—With regard to infor22 mation to be reported by the Food and Drug 

23 Administration to industry on a quarterly and 

24 annual basis pursuant to recommendations 

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1 suant to subsection (b)(1)(F), the Secretary 

2 shall make such information publicly available 

3 on the website of the Food and Drug Adminis4 tration not later than 60 days after the end of 

5 each quarter or 120 days after the end of each 

6 fiscal year, respectively, to which such informa7 tion applies. 

8 (C) UPDATES.—The Secretary shall in9 clude in each report under subparagraph (A) 

10 information on all previous cohorts for which 

11 the Secretary has not given a complete response 

12 on all in vitro clinical test premarket applica13 tions and technology certification orders and 

14 supplements, premarket, and technology certifi15 cation notifications in the cohort. 

16 (2) CORRECTIVE ACTION REPORT.—Beginning 

17 with fiscal year 2029, for each fiscal year for which 

18 fees are collected under this section, the Secretary 

19 shall prepare and submit a corrective action report 

20 to the Committee on Health, Education, Labor, and 

21 Pensions and the Committee on Appropriations of 

22 the Senate and the Committee on Energy and Com23 merce and the Committee on Appropriations of the 

24 House of Representatives. The report shall include 

25 the following information, as applicable: 


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1 (A) GOALS MET.—For each fiscal year, if 

2 the Secretary determines, based on the analysis 

3 under paragraph (1)(A)(v), that each of the 

4 goals identified by the recommendations trans5 mitted to Congress by the Secretary pursuant 

6 to subsection (b)(1)(F) for the applicable fiscal 

7 year have been met, the corrective action report 

8 shall include recommendations on ways in which 

9 the Secretary can improve and streamline the in 

10 vitro clinical test premarket application and 

11 technology certification review process. 

12 (B) GOALS MISSED.—For each of the goals 

13 identified by the letters described in rec14 ommendations transmitted to Congress by the 

15 Secretary pursuant to subsection (b)(1)(F) for 

16 the applicable fiscal year that the Secretary de17 termines to not have been met, the corrective 

18 action report shall include— 

19 (i) a justification for such determina20 tion; 

21 (ii) a description of the types of cir22 cumstances, in the aggregate, under which 

23 applications or reports submitted under 

24 sections 587B and 587D of the Federal 

25 Food, Drug, and Cosmetic Act missed the 


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1 review goal times but were approved dur2 ing the first cycle review, as applicable; 

3 (iii) a summary and any trends with 

4 regard to the circumstances for which a re5 view goal was missed; and 

6 (iv) the performance enhancement 

7 goals that were not achieved during the 

8 previous fiscal year and a description of ef9 forts the Food and Drug Administration 

10 has put in place for the fiscal year in 

11 which the report is submitted to improve 

12 the ability of such agency to meet each 

13 such goal for the such fiscal year. 

14 (3) FISCAL REPORT.— 

15 (A) IN GENERAL.—For fiscal years 2029 

16 and annually thereafter, not later than 120 

17 days after the end of each fiscal year during 

18 which fees are collected under this section, the 

19 Secretary shall prepare and submit to the Com20 mittee on Health, Education, Labor, and Pen21 sions of the Senate and the Committee on En22 ergy and Commerce of the House of Represent23 atives, a report on the implementation of the 

24 authority for such fees during such fiscal year 

25 and the use, by the Food and Drug AdministraVerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00269 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369

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1 tion, of the fees collected during such fiscal 

2 year for which the report is made. 

3 (B) CONTENTS.—Such report shall include 

4 expenditures delineated by budget authority and 

5 user fee dollars related to administrative ex6 penses and information technology infrastruc7 ture contracts and expenditures. 

8 (C) OPERATING RESERVE.—Such report 

9 shall provide the amount of operating reserves 

10 of carryover user fees available each year, and 

11 any planned allocations or obligations of such 

12 balance of operating reserves for the program. 

13 (4) PUBLIC AVAILABILITY.—The Secretary 

14 shall make the reports required under paragraphs 

15 (1) through (3) available to the public on the website 

16 of the Food and Drug Administration. 

17 (5) ENHANCED COMMUNICATION.— 

18 (A) COMMUNICATIONS WITH CONGRESS.— 

19 Each fiscal year, as applicable and requested, 

20 representatives from the Centers with expertise 

21 in the review of in vitro clinical tests shall meet 

22 with representatives from the Committee on 

23 Health, Education, Labor, and Pensions of the 

24 Senate and the Committee on Energy and Com25 merce of the House of Representatives to report 


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1 on the contents described in the reports under 

2 this section. 

3 (B) PARTICIPATION IN CONGRESSIONAL

4 HEARING.—Each fiscal year, as applicable and 

5 requested, representatives from the Food and 

6 Drug Administration shall participate in a pub7 lic hearing before the Committee on Health, 

8 Education, Labor, and Pensions of the Senate 

9 and the Committee on Energy and Commerce 

10 of the House of Representatives, to report on 

11 the contents described in the reports under this 

12 section. Such hearing shall occur not later than 

13 120 days after the end of each fiscal year for 

14 which fees are collected under this section. 

15 SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 

16 For purposes of funding implementation of this Act 

17 (including the amendments made by this Act), including 

18 undertaking activities for the development of regulations 

19 and guidances, hiring of necessary staff, and the develop20 ment of technology systems to implement this Act (includ21 ing the amendments made by this Act) in a timely, effec22 tive, and efficient manner, there is authorized to be appro23 priated $480,000,000, to remain available through the end 

24 of fiscal year 2028. 


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1 SEC. 11. GUIDANCE ON DIAGNOSTIC INNOVATION. 

2 Not later than January 1, 2025, the Secretary shall 

3 issue guidance to assist developers of in vitro clinical tests 

4 intended to identify or diagnose rare diseases and in vitro 

5 clinical tests intended to address an unmet medical need. 

6 Such guidance shall include considerations for addressing 

7 barriers to developing sufficient data to demonstrate clin8 ical validity for such tests, such as challenges associated 

9 with data collection and obstacles to the timely generation 

10 of evidence. 

11 SEC. 12. GAO REPORT ON UNIQUE CONSIDERATIONS. 

12 Not later than 3 years after the date of enactment 

13 of this Act, the Comptroller General of the United States 

14 shall submit to the Committee on Health, Education, 

15 Labor, and Pensions of the Senate and the Committee on 

16 Energy and Commerce of the House of Representatives 

17 a report— 

18 (1) evaluating the unique considerations for 

19 hospital-based laboratories, laboratories serving aca20 demic medical centers, and other health care practi21 tioners, as appropriate, in implementing this Act, in22 cluding the amendments made by this Act; and 

23 (2) including recommendations based on the 

24 findings of the report. 


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1 SEC. 13. ASSESSMENTS. 

2 Section 1834A(g) of the Social Security Act (42 

3 U.S.C. 1395m–1(g)) is amended by adding at the end the 

4 following new paragraph: 

5 ‘‘(3) DETERMINATIONS WITH RESPECT TO IN

6 VITRO CLINICAL TESTS.—On or after the date that 

7 is 45 days after the date of enactment of the 

8 VALID Act of 2023, for purposes of determining 

9 whether an in vitro clinical test (as defined in sec10 tion 201(ss) of the Federal Food, Drug, and Cos11 metic Act) is reasonable and necessary for the diag12 nosis or treatment of illness or injury (under section 

13 1862(a)(1)(A)), any assessment of the analytical va14 lidity or clinical validity of such test shall apply the 

15 definitions given such terms in subchapter J of 

16 chapter V of the Federal Food, Drug, and Cosmetic 

17 Act.’’. 

18 SEC. 14. SEVERABILITY. 

19 If any provision of this Act is declared unconstitu20 tional, or the applicability of this Act to any person or 

21 circumstance is held invalid, the constitutionality of the 

22 remainder of this Act and the applicability thereof to other 

23 persons and circumstances shall not be affected. 

Æ 


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