II 

117TH CONGRESS 

1ST SESSION S. 2209 

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

regulation of in vitro clinical tests, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 24, 2021 

Mr. BURR (for himself and Mr. BENNET) introduced the following bill; which 

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

Labor, and Pensions 

A BILL 

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

provide for the regulation of 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; TABLE OF CONTENTS. 

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

5 ‘‘Verifying Accurate Leading-edge IVCT Development Act 

6 of 2021’’ or the ‘‘VALID Act of 2021’’. 

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

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Definitions. 


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Sec. 3. Regulation of in vitro clinical tests. 

‘‘SUBCHAPTER J—IN VITRO CLINICAL TESTS

‘‘Sec. 587. Definitions. 

‘‘Sec. 587A. Applicability. 

‘‘Sec. 587B. Premarket review. 

‘‘Sec. 587C. Breakthrough in vitro clinical tests. 

‘‘Sec. 587D. Technology certification. 

‘‘Sec. 587E. Mitigating measures. 

‘‘Sec. 587F. Regulatory pathway redesignation. 

‘‘Sec. 587G. Advisory committees. 

‘‘Sec. 587H. Request for informal feedback. 

‘‘Sec. 587I. Registration and listing. 

‘‘Sec. 587J. Test design and quality requirements. 

‘‘Sec. 587K. Labeling requirements. 

‘‘Sec. 587L. Adverse event reporting. 

‘‘Sec. 587M. Corrections and removals. 

‘‘Sec. 587N. Restricted in vitro clinical tests. 

‘‘Sec. 587O. Appeals. 

‘‘Sec. 587P. Accredited persons. 

‘‘Sec. 587Q. Recognized standards. 

‘‘Sec. 587R. Investigational use. 

‘‘Sec. 587S. Collaborative communities for in vitro clinical tests. 

‘‘Sec. 587T. Comprehensive test information system. 

‘‘Sec. 587U. Preemption. 

‘‘Sec. 587V. Adulteration. 

‘‘Sec. 587W. Misbranding. 

‘‘Sec. 587X. Postmarket surveillance. 

‘‘Sec. 587Y. Electronic format for submissions. 

‘‘Sec. 587Z. Postmarket remedies. 

Sec. 4. Enforcement and other provisions. 

Sec. 5. Transition. 

Sec. 6. Emergency use authorization. 

Sec. 7. Antimicrobial susceptibility tests. 

Sec. 8. Combination products. 

Sec. 9. Resources. 

1 SEC. 2. DEFINITIONS. 

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

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

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

5 ‘‘(ss)(1) The term ‘in vitro clinical test’— 

6 ‘‘(A) means a test intended by its developer (as 

7 defined in section 587) to be used in the collection, 

8 preparation, analysis, or in vitro clinical examination 


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1 of specimens taken or derived from the human body 

2 for the purpose of— 

3 ‘‘(i) identifying or diagnosing a disease or 

4 condition; 

5 ‘‘(ii) providing information for diagnosing, 

6 screening, measuring, detecting, predicting, 

7 prognosing, analyzing, or monitoring a disease 

8 or condition, including by making a determina9 tion of an individual’s state of health; or 

10 ‘‘(iii) selecting, monitoring, or informing 

11 therapy or treatment for a disease or condition; 

12 and 

13 ‘‘(B) may include— 

14 ‘‘(i) a test protocol or laboratory test pro15 tocol; 

16 ‘‘(ii) an instrument (as defined in section 

17 587(11)); 

18 ‘‘(iii) a specimen receptacle; 

19 ‘‘(iv) software, excluding software that is 

20 excluded by section 520(o) from the definition 

21 of a device under section 201(h), and excluding 

22 modifications that are exempt in accordance 

23 with section 587A(l)(2)(A); and 

24 ‘‘(v) subject to subparagraph (2), a compo25 nent or part of a test, a test protocol, an instruVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 ment, an article, or software described in any of 

2 clauses (A) through (D) of such subparagraph, 

3 whether alone or in combination, including re4 agents, calibrators, and controls. 

5 ‘‘(2) Notwithstanding subparagraph (1)(v), an article 

6 intended to be used as a component or part of an in vitro 

7 clinical test described in subparagraph (1) is excluded 

8 from the definition in subparagraph (1) if the article con9 sists of any of the following: 

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

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

12 recovery of such article, including determination of 

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

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

15 vitro clinical test by the establishment that collected 

16 such article. 

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

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

19 needle, or lancet is an integral component of an arti20 cle for holding, storing, or transporting a specimen. 

21 ‘‘(C) General purpose laboratory equipment, in22 cluding certain pre-analytical equipment, as deter23 mined by the Secretary. 


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1 ‘‘(D) An article used solely for personal protec2 tion during the administering, conducting, or other3 wise performing of test activities.’’; 

4 (2) by adding at the end of section 201(g) the 

5 following: 

6 ‘‘(3) The term ‘drug’ does not include an in vitro clin7 ical test.’’; and 

8 (3) in section 201(h), by striking ‘‘section 

9 520(o)’’ and inserting ‘‘section 520(o) or an in vitro 

10 clinical test’’. 

11 (b) EXCLUSION FROM DEFINITION OF BIOLOGICAL

12 PRODUCT.—Section 351(i)(1) of the Public Health Serv13 ice Act (42 U.S.C. 262(i)(1)) is amended— 

14 (1) by striking ‘‘(1) The term ‘biological prod15 uct’ means’’ and inserting ‘‘(1)(A) The term ‘biologi16 cal product’ means’’; and 

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

18 ‘‘(B) The term ‘biological product’ does not in19 clude an in vitro clinical test as defined in section 

20 201(ss) of the Federal Food, Drug, and Cosmetic 

21 Act.’’. 

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

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

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

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


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

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

3 U.S.C. 301 et seq.) is amended— 

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

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

6 VITRO CLINICAL TESTS’’; and 

7 (2) by adding at the end of chapter V the fol8 lowing: 

9 ‘‘Subchapter J—In Vitro Clinical Tests 

10 ‘‘SEC. 587. DEFINITIONS. 

11 ‘‘In this subchapter: 

12 ‘‘(1) ANALYTICAL VALIDITY.— 

13 ‘‘(A) The term ‘analytical validity’ means, 

14 with respect to an in vitro clinical test, the abil15 ity of the in vitro clinical test, to— 

16 ‘‘(i) sufficiently identify, measure, de17 tect, calculate, or analyze one or more 

18 analytes, biomarkers, substances, or other 

19 targets intended to be identified, measured, 

20 detected, calculated, or analyzed by the 

21 test; or 

22 ‘‘(ii) as applicable, assist in such iden23 tification, measurement, detection, calcula24 tion, or analysis. 

25 ‘‘(B) For an article for taking or deriving 

26 specimens from the human body described in 


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1 section 201(ss)(1)(B)(iii), the term ‘analytical 

2 validity’ means that such article performs as in3 tended and will support the analytical validity 

4 of an in vitro clinical test with which it is used. 

5 ‘‘(2) APPLICABLE STANDARD.—The term ‘ap6 plicable standard’, with respect to an in vitro clinical 

7 test, means a reasonable assurance of analytical and 

8 clinical validity, except that such term— 

9 ‘‘(A) with respect to test instruments, 

10 means a reasonable assurance of analytical va11 lidity; and 

12 ‘‘(B) with respect to articles for taking or 

13 deriving specimens from the human body for 

14 purposes described in clause (i) or (ii) of section 

15 201(ss)(1)(A) means a reasonable assurance of 

16 analytical validity and, where applicable, safety. 

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

18 means the operation, application, or functioning of 

19 an in vitro clinical test in connection with human 

20 specimens, including patient, consumer, and donor 

21 specimens, for the purpose for which it is intended 

22 as described in section 201(ss)(1)(A). 

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

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


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1 to achieve the purpose for which it is intended as de2 scribed in section 201(ss)(1)(A). 

3 ‘‘(5) CROSS-REFERENCED TEST.—The term 

4 ‘cross-referenced test’ means an in vitro clinical test 

5 that references in its labeling the name or intended 

6 use of another medical product that is not an in 

7 vitro clinical test. 

8 ‘‘(6) DEVELOP.—The term ‘develop’, with re9 spect to an in vitro clinical test, means— 

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

11 manufacturing, remanufacturing, propagating, 

12 or assembling an in vitro clinical test; 

13 ‘‘(B) importing an in vitro clinical test; 

14 ‘‘(C) modifying an in vitro clinical test ini15 tially developed by a different person in a man16 ner that— 

17 ‘‘(i) changes any of the listing ele18 ments that define indications for use speci19 fied in paragraph (10), performance 

20 claims, or, as applicable, the safety of such 

21 in vitro clinical test; or 

22 ‘‘(ii) affects the analytical or clinical 

23 validity of the in vitro clinical test as in24 tended by the developer; or 


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1 ‘‘(D) adopting, using, or disseminating for 

2 use as an in vitro clinical test an article not 

3 previously intended for clinical use. 

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

5 a person who engages in an activity described in 

6 paragraph (6) for clinical use. 

7 ‘‘(8) FIRST-OF-A-KIND.—The term ‘first-of-a8 kind’ means, with respect to an in vitro clinical test, 

9 a test that has an intended use and a combination 

10 of the elements specified in paragraph (10) that dif11 fer from the intended use and such elements of 

12 other in vitro clinical tests that already are legally 

13 available in the United States. 

14 ‘‘(9) HIGH-RISK.— 

15 ‘‘(A) IN GENERAL.—Subject to subpara16 graph (B), the term ‘high-risk’, with respect to 

17 an in vitro clinical test or category of in vitro 

18 clinical tests— 

19 ‘‘(i) means that, when used as in20 tended by the developer, an undetected in21 accurate result from such test or cat22 egory— 

23 ‘‘(I) presents unreasonable risk 

24 for serious or irreversible harm or 

25 death to a patient or patients, or 


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1 would otherwise cause serious harm to 

2 the public health; or 

3 ‘‘(II) is potentially likely to result 

4 in the absence, significant delay, or 

5 discontinuation of life-supporting or 

6 life-sustaining medical treatment; and 

7 ‘‘(ii) shall account for the degree to 

8 which the technology for the intended use 

9 of an in vitro clinical test or tests is well10 characterized and the criteria for perform11 ance of the test or tests are well-estab12 lished for the intended use, the clinical cir13 cumstances under which the in vitro clin14 ical test is used, and the availability of 

15 other tests (such as confirmatory or ad16 junctive tests). 

17 ‘‘(B) EXCEPTION.—The term ‘high-risk’ 

18 does not include an in vitro clinical test de19 scribed in subparagraph (A) if— 

20 ‘‘(i) mitigating measures are estab21 lished to prevent, detect, or otherwise miti22 gate the risk of inaccurate results as de23 scribed in subparagraph (A), or 

24 ‘‘(ii) an exemption from the definition 

25 of such term applies under section 587A. 


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1 ‘‘(10) INDICATIONS FOR USE.—The term ‘indi2 cations for use’ means one or more in vitro clinical 

3 tests that have all of the following notification ele4 ments in common: 

5 ‘‘(A) Substance or substances measured by 

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

7 protein, or pathogen. 

8 ‘‘(B) Test method. 

9 ‘‘(C) Test purpose or purposes, as de10 scribed in section 201(ss)(1)(A). 

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

12 in vitro clinical test is intended for use, includ13 ing intended patient populations. 

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

15 laboratory, in a health care facility, prescription 

16 home use, over-the-counter use, or direct-to17 consumer testing. 

18 ‘‘(11) INSTRUMENT.—The term ‘instrument’ 

19 means an in vitro clinical test that is hardware in20 tended by the hardware’s developer to be used with 

21 one or more in vitro clinical tests to generate a clin22 ical test result, including software used to effectuate 

23 the hardware’s functionality. 

24 ‘‘(12) INSTRUMENT FAMILY.—The term ‘instru25 ment family’ means more than one instrument for 


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1 which the developer demonstrates and documents, 

2 with respect to all such instruments, that all— 

3 ‘‘(A) have the same basic architecture, de4 sign, and performance characteristics, such as 

5 tolerance limits and signal range; 

6 ‘‘(B) have the same intended use or uses 

7 and function; 

8 ‘‘(C) share the same measurement prin9 ciples, detection methods, and reaction condi10 tions; and 

11 ‘‘(D) produce the same or similar analyt12 ical results from samples of the same specimen 

13 type or types. 

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

15 ‘laboratory operations’— 

16 ‘‘(A) means the conduct of a laboratory ex17 amination or other laboratory procedure on ma18 terials derived from the human body, including 

19 the conduct of an in vitro clinical test and asso20 ciated activities within or under the oversight of 

21 a laboratory and not related to the design 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) conducting standard operating 

5 procedures; and 

6 ‘‘(iii) preparing reagents or other test 

7 materials that do not meet the definition of 

8 a in vitro clinical test for clinical use under 

9 section 201(ss). 

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 by the developer— 

16 ‘‘(A) would cause minimal or no harm, or 

17 minimal or no disability, or immediately revers18 ible harm, or would lead to only a remote risk 

19 of adverse patient impact or adverse public 

20 health impact, taking into account the degree to 

21 which the technology for the intended use of an 

22 in vitro clinical test or category of tests is well23 characterized and the criteria for performance 

24 of the test or category of tests are well-estab25 lished for the intended use, the clinical cirVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 cumstances under which the in vitro clinical 

2 test or category of tests is used, and the avail3 ability of other tests (such as confirmatory or 

4 adjunctive tests); or 

5 ‘‘(B) would cause a serious adverse health 

6 consequence, harm that is reversible, a delay in 

7 necessary treatment that is not life-supporting 

8 or life-sustaining, or would lead to a serious 

9 risk of adverse patient experience or adverse 

10 public health impact, but applied mitigating 

11 measures have the capacity to ensure the test 

12 meets the standard described in subparagraph 

13 (A). 

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

15 ‘mitigating measures’— 

16 ‘‘(A) means controls, standards, or require17 ments that the Secretary determines, based on 

18 available evidence— 

19 ‘‘(i) are necessary for an in vitro clin20 ical test, or a category of in vitro clinical 

21 tests, to meet the applicable standard; or 

22 ‘‘(ii) to mitigate the risk of harm en23 suing from an inaccurate result such that 

24 a test or category of tests subject to such 

25 mitigating measures does not meet the defVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 inition of high risk, or such that a test or 

2 category of tests subject to such mitigating 

3 measures is low risk; and 

4 ‘‘(B) includes, as appropriate, applicable 

5 requirements regarding labeling, conformance 

6 to performance standards or guidance, perform7 ance testing, submission of clinical data, adver8 tising, website posting of information, clinical 

9 studies, postmarket surveillance, user com10 prehension studies, training, and availability of 

11 confirmatory laboratory or clinical findings. 

12 ‘‘(16) SPECIMEN RECEPTACLE.—The term 

13 ‘specimen receptacle’ means an in vitro clinical test 

14 specifically intended for the holding, storing, or 

15 transporting of specimens derived from the human 

16 body or for in vitro examination for purposes de17 scribed in clause (i) or (ii) of section 201(ss)(1)(A). 

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

19 ‘‘(A) means a developer’s grouping of in 

20 vitro clinical tests that do not significantly dif21 fer in control mechanisms, energy sources, or 

22 operating principals and for which design, de23 velopment, and manufacturing, including ana24 lytical and clinical validation as applicable, of 


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1 the tests would be addressed in a similar man2 ner or through similar procedures; and 

3 ‘‘(B) may include clot detection, colori4 metric (non-immunoassay), electrochemical 

5 (non-immunoassay), enzymatic (non6 immunoassay), flow cytometry, fluorometry 

7 (non-immunoassay), immunoassay, mass spec8 trometry or chromatography (such as HPLC), 

9 microbial culture, next generation sequencing 

10 (also known as ‘NGS’), nephlometric or turbi11 dimetric (non-immunoassay), singleplex or mul12 tiplex non-NGS nucleic acid analysis, single13 based technology, spectroscopy, and any other 

14 technology, as the Secretary determines appro15 priate. 

16 ‘‘(18) TEST.—The term ‘test’, unless otherwise 

17 provided, means an in vitro clinical test. 

18 ‘‘(19) VALID SCIENTIFIC EVIDENCE.—The term 

19 ‘valid scientific evidence’— 

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

21 clinical test, evidence— 

22 ‘‘(i) that has been generated and eval23 uated by persons qualified by training or 

24 experience to do so, using procedures genVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 erally accepted by other persons so quali2 fied; and 

3 ‘‘(ii) from which it can be fairly and 

4 responsibly concluded by qualified experts 

5 whether the applicable standard has been 

6 met by the in vitro clinical test for its in7 tended use; and 

8 ‘‘(B) may include evidence described in 

9 subparagraph (A) consisting of— 

10 ‘‘(i) peer-reviewed literature; 

11 ‘‘(ii) clinical guidelines; 

12 ‘‘(iii) reports of significant human ex13 perience with an in vitro clinical test; 

14 ‘‘(iv) bench studies; 

15 ‘‘(v) case studies or histories; 

16 ‘‘(vi) clinical data; 

17 ‘‘(vii) consensus standards; 

18 ‘‘(viii) reference standards; 

19 ‘‘(ix) data registries; 

20 ‘‘(x) postmarket data; 

21 ‘‘(xi) real world data; 

22 ‘‘(xii) clinical trials; and 

23 ‘‘(xiii) data collected in countries 

24 other than the United States if such data 

25 are demonstrated to be adequate for the 


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1 purpose of making a regulatory determina2 tion under the applicable standard in the 

3 United States. 

4 ‘‘(20) WELL-CHARACTERIZED.—The term ‘well5 characterized’, with respect to an in vitro clinical 

6 test, means well-established and well-recognized by 

7 the scientific or clinical community, if adequately 

8 evidenced by one or more of the following: 

9 ‘‘(A) Peer-reviewed literature. 

10 ‘‘(B) Practice guidelines. 

11 ‘‘(C) Consensus standards. 

12 ‘‘(D) Recognized standards of care. 

13 ‘‘(E) Technology in use for many years. 

14 ‘‘(F) Scientific publication by multiple 

15 sites. 

16 ‘‘(G) Adoption by the scientific or clinical 

17 community. 

18 ‘‘(H) Real world data. 

19 ‘‘SEC. 587A. APPLICABILITY. 

20 ‘‘(a) IN GENERAL.— 

21 ‘‘(1) APPLICABILITY OF THIS SUBCHAPTER.— 

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

23 test shall be subject to the requirements of this 

24 subchapter, except as otherwise provided this 

25 subchapter. 


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1 ‘‘(B) INTERSTATE COMMERCE.—Any in 

2 vitro clinical test that is offered for clinical use 

3 in the United States is deemed to be introduced 

4 into interstate commerce for purposes of enforc5 ing the requirements of this Act. 

6 ‘‘(C) NON-APPLICABLE REQUIREMENT.— 

7 Subject to any exemption or exclusion in this 

8 section, an in vitro clinical test shall not be sub9 ject to any provision or requirement of this Act 

10 other than this subchapter unless such other 

11 provision or requirement— 

12 ‘‘(i) applies expressly to in vitro clin13 ical tests; or 

14 ‘‘(ii) describes the authority of the 

15 Secretary when regulating such in vitro 

16 clinical tests or subset of in vitro clinical 

17 tests, with respect to— 

18 ‘‘(I) all articles regulated by the 

19 Secretary pursuant to this Act; or 

20 ‘‘(II) a subset of such articles 

21 that includes in vitro clinical tests. 

22 ‘‘(2) LABORATORIES AND BLOOD AND TISSUE

23 ESTABLISHMENTS.— 

24 ‘‘(A) RELATION TO LABORATORY CERTIFI25 CATION PURSUANT TO SECTION 353 OF THE


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1 PHSA.—Nothing in this subchapter shall be 

2 construed to modify the authority of the Sec3 retary with respect to laboratories or clinical 

4 laboratories under section 353 of the Public 

5 Health Service Act. 

6 ‘‘(B) AVOIDING DUPLICATION.—In imple7 menting this subchapter, the Secretary shall 

8 avoid issuing or enforcing regulations that are 

9 duplicative of regulations under section 353. 

10 ‘‘(C) BLOOD AND TISSUE.—Nothing in 

11 this subchapter shall be construed to modify the 

12 authority of the Secretary with respect to lab13 oratories, establishments, or other facilities to 

14 the extent they are engaged in the propagation, 

15 manufacture, or preparation, including filling, 

16 testing, labeling, packaging, and storage, of 

17 blood, blood components, human cells, tissues, 

18 or tissue products under this Act or section 351 

19 or 361 of the Public Health Service Act. 

20 ‘‘(3) PRACTICE OF MEDICINE.— 

21 ‘‘(A) IN GENERAL.—Nothing in this sub22 chapter shall be construed to limit or interfere 

23 with the authority of a health care practitioner 

24 to prescribe or administer any legally marketed 

25 in vitro clinical test for any condition or disease 


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1 within a health care practitioner-patient rela2 tionship pursuant to applicable Federal or State 

3 law. 

4 ‘‘(B) RULES OF CONSTRUCTION.— 

5 ‘‘(i) SALE, DISTRIBUTION, LABEL6 ING.—Nothing in this paragraph shall be 

7 construed to limit the authority of the Sec8 retary to establish or enforce restrictions 

9 on the sale, distribution, or labeling of an 

10 in vitro clinical test under this Act. 

11 ‘‘(ii) PROMOTION OF UNAPPROVED

12 USES.—Nothing in this paragraph shall be 

13 construed to alter any prohibition on the 

14 promotion of unapproved uses of legally 

15 marketed in vitro clinical tests. 

16 ‘‘(4) SPECIAL RULE.— 

17 ‘‘(A) PREMARKET REVIEW APPLICABLE.— 

18 Notwithstanding the exemptions from pre19 market review under section 587B set forth in 

20 subsections (b), (c), (d), (e), (f), (g), (h), (j), 

21 and (k) of such section, an in vitro clinical test 

22 (including any article for taking or deriving 

23 specimens) shall be subject to the requirements 

24 of section 587B if the Secretary determines, in 

25 accordance with subparagraph (B), that— 


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1 ‘‘(i)(I) there is insufficient valid sci2 entific evidence to support the analytical 

3 validity or the clinical validity of such in 

4 vitro clinical test; and 

5 ‘‘(II) such in vitro clinical test is 

6 being offered by its developer with materi7 ally deceptive or fraudulent analytical or 

8 clinical claims; 

9 ‘‘(ii) it is reasonably possible that 

10 such in vitro clinical test will cause serious 

11 adverse health consequences; or 

12 ‘‘(iii) in the case of specimen recep13 tacles, there is sufficient valid scientific 

14 evidence indicating that a specimen recep15 tacle did not perform as intended, will not 

16 support the analytical validity of tests with 

17 which it is used, or as applicable, is not 

18 safe for use. 

19 ‘‘(B) PROCESS.— 

20 ‘‘(i) REQUEST FOR INFORMATION.—If 

21 the Secretary has valid scientific evidence 

22 indicating that the criteria listed in sub23 paragraph (A) apply to an in vitro clinical 

24 test, the Secretary may request that the 

25 developer of the test submit information— 


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1 ‘‘(I) pertaining to such criteria; 

2 and 

3 ‘‘(II) establishing the basis for 

4 any claimed exemption from pre5 market review. 

6 ‘‘(ii) DEADLINE FOR SUBMITTING IN7 FORMATION.—The developer of an in vitro 

8 clinical test shall submit the information 

9 requested pursuant to clause (i) within 30 

10 days of receipt of such request. 

11 ‘‘(iii) REVIEW DEADLINE.—Upon re12 ceiving a submission under clause (ii), the 

13 Secretary shall— 

14 ‘‘(I) review the submitted infor15 mation within 60 calendar days of 

16 such receipt; and 

17 ‘‘(II) determine whether the cri18 teria listed in subparagraph (A) apply 

19 to the in vitro clinical test. 

20 ‘‘(iv) PREMARKET REVIEW RE21 QUIRED.— 

22 ‘‘(I) IN GENERAL.—If the Sec23 retary finds that the criteria listed in 

24 subparagraph (A) apply to the in vitro 

25 clinical test, the developer shall— 


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1 ‘‘(aa) promptly, and not 

2 later than 90 days after the date 

3 of receipt of such information, 

4 submit an application for pre5 market review of the test under 

6 section 587B; or 

7 ‘‘(bb) cease to market the 

8 test. 

9 ‘‘(II) EXTENSION.—The Sec10 retary may grant an extension to a 

11 developer of the 90-day time period 

12 under subclause (I)(aa), as appro13 priate. 

14 ‘‘(v) CONTINUED MARKETING.—Dur15 ing the period beginning on the date of a 

16 request for information under clause (ii) 

17 and ending on the date of the disposition 

18 of an application for premarket review of 

19 the in vitro clinical test under section 

20 587B, the developer of the test may con21 tinue to market the test for clinical use, 

22 unless the Secretary issues an order to the 

23 developer under clause (vi) to immediately 

24 cease distribution of the test. 


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1 ‘‘(vi) ORDER TO CEASE DISTRIBU2 TION.— 

3 ‘‘(I) IN GENERAL.—If the devel4 oper of an in vitro clinical test fails to 

5 submit an application for premarket 

6 review of the test by the deadline ap7 plicable under clause (iv), or the Sec8 retary finds that the criteria listed in 

9 subparagraph (A) apply to an in vitro 

10 clinical test and that it is in the best 

11 interest of the public health, the Sec12 retary may issue an order, within 10 

13 calendar days of the applicable dead14 line or finding by the Secretary, re15 quiring the developer of such in vitro 

16 clinical test, and any other appro17 priate person (including a distributor 

18 or retailer of the in vitro clinical test) 

19 to immediately— 

20 ‘‘(aa) cease distribution of 

21 the test pending approval of an 

22 application for premarket review 

23 of the test under section 587B; 

24 and 


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1 ‘‘(bb) notify health profes2 sionals and other user facilities of 

3 the order to cease distribution 

4 and advise health care profes5 sionals to cease use of such in 

6 vitro clinical test. 

7 ‘‘(II) HEARING AND REVIEW.— 

8 An order under subclause (I) shall 

9 provide the person subject to the 

10 order with an opportunity for an in11 formal hearing, to be held not later 

12 than 10 days after the date of the 

13 issuance of the order, on the actions 

14 required by the order and on whether 

15 the order should be amended to re16 quire a recall of such in vitro clinical 

17 test. If, after providing an opportunity 

18 for such a hearing, the Secretary de19 termines that inadequate grounds 

20 exist to support the actions required 

21 by the order, the Secretary shall ter22 minate the order within 30 days of 

23 the hearing. Upon terminating an 

24 order, the Secretary shall provide 


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1 written notice of such termination to 

2 the developer. 

3 ‘‘(vii) AMENDMENT TO REQUIRE RE4 CALL.—If the Secretary determines that 

5 an order issued under clause (vi) should be 

6 amended to include a recall of the in vitro 

7 clinical test with respect to which the order 

8 was issued, the Secretary shall amend the 

9 order to require a recall. In such amended 

10 order, the Secretary shall specify a time11 frame in which the in vitro clinical test re12 call will occur and shall require periodic re13 ports to the Secretary describing the 

14 progress of the recall. Upon termination of 

15 the recall, the Secretary shall provide writ16 ten notice of such termination to the devel17 oper. 

18 ‘‘(viii) EFFECT OF TEST APPROVAL.— 

19 Any order issued under this paragraph 

20 with respect to an in vitro clinical test 

21 shall cease to be in effect if such test is 

22 granted approval under section 587B, pro23 vided that the in vitro clinical test is devel24 oped and offered for clinical use in accord25 ance with such approval. 


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1 ‘‘(5) EMERGENCY USE.— 

2 ‘‘(A) IN GENERAL.—In the case of a deter3 mination under section 319(a) of the Public 

4 Health Service Act or a declaration under sec5 tion 564(b) of this Act, an in vitro clinical test 

6 is exempt from the requirements of this sub7 chapter and may be lawfully marketed in ac8 cordance with subparagraph (B). 

9 ‘‘(B) CRITERIA.—An in vitro clinical test 

10 is exempt from the requirements of this sub11 chapter and may be lawfully marketed in ac12 cordance with the exemption described in sub13 paragraph (A) if— 

14 ‘‘(i) such test— 

15 ‘‘(I) is submitted for emergency 

16 use authorization under section 

17 564(b); or 

18 ‘‘(II) is developed and used in 

19 laboratories for which a certificate is 

20 in effect under section 353 of the 

21 Public Health Service Act to conduct 

22 high-complexity testing and the devel23 oper; and 

24 ‘‘(ii) the developer— 


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1 ‘‘(I) validates such in vitro clin2 ical test prior to use; 

3 ‘‘(II) notifies the Secretary of the 

4 assay validation; and 

5 ‘‘(III) submits an emergency use 

6 authorization application under sec7 tion 564 within 15 calendar days of 

8 marketing the test. 

9 ‘‘(C) DISPOSITION OF PRODUCT.—With re10 spect to a previously unapproved in vitro clin11 ical test or an in vitro clinical test with an un12 approved use, for which an emergency use au13 thorization under section 564(b) ceases to be 

14 effective, the Secretary shall consult with the 

15 manufacturer of such product with respect to 

16 the appropriate disposition of the product. 

17 ‘‘(D) STREAMLINING OF APPLICATION RE18 VIEW.—A developer may include any data or in19 formation already submitted to the Secretary 

20 within the emergency use authorization as a 

21 part of a premarket application under section 

22 587B or a technology certification application 

23 under section 587D. 

24 ‘‘(6) EFFECT ON OTHER LAWS.—Any in vitro 

25 clinical test that is lawfully marketed under this Act, 


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1 including tests that are approved under section 

2 587B, cleared pursuant to an active technology cer3 tification order under section 587D, or exempt from 

4 premarket review under an exemption in this sec5 tion, shall be eligible for introduction into interstate 

6 commerce except as otherwise provided in this sub7 chapter. 

8 ‘‘(b) COMPONENTS AND PARTS.— 

9 ‘‘(1) EXEMPTION.— 

10 ‘‘(A) IN GENERAL.—Subject to subpara11 graph (B), a component, part, or raw material 

12 described in section 201(ss)(1)(B)(v) is exempt 

13 from the requirements of this subchapter if it 

14 is— 

15 ‘‘(i) intended for further development 

16 as described in paragraph (2); or 

17 ‘‘(ii) otherwise to be regulated based 

18 on its risk when used as intended by the 

19 developer, notwithstanding its subsequent 

20 use by a developer as a component, part, 

21 or raw material of another in vitro clinical 

22 test. 

23 ‘‘(B) INAPPLICABILITY TO OTHER

24 TESTS.—Notwithstanding subparagraph (A), an 

25 in vitro clinical test that is described in section 


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1 201(ss)(1)(B) and that uses a component or 

2 part described in such subparagraph shall be 

3 subject to the requirements of this subchapter, 

4 unless the test is otherwise exempt under this 

5 section. 

6 ‘‘(2) FURTHER DEVELOPMENT.—A component, 

7 part, or raw material (as described in paragraph 

8 (1)(A)) is intended for further development (for pur9 poses of such paragraph) if— 

10 ‘‘(A) it is intended solely for use in the de11 velopment of another in vitro clinical test; and 

12 ‘‘(B) in the case of such a test that is in13 troduced or delivered for introduction into 

14 interstate commerce after the date of enactment 

15 of the Verifying Accurate Leading-edge IVCT 

16 Development Act of 2021, the labeling of such 

17 test bears the following statement: ‘This prod18 uct is intended solely for further development of 

19 an in vitro clinical test and is exempt from 

20 FDA regulation. This product must be evalu21 ated by the in vitro clinical test developer if it 

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

23 clinical test.’. 

24 ‘‘(c) GRANDFATHERED TESTS.— 


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

2 meets the criteria set forth in paragraph (2) is ex3 empt from the requirements of this subchapter, ex4 cept as provided under subsection (a)(4), the reg5 istration and listing requirements under section 

6 587I, and the adverse reporting requirements under 

7 section 587L, and may be lawfully marketed subject 

8 to the other applicable requirements of this Act, if— 

9 ‘‘(A) each test report template for the test 

10 bears a statement of adequate prominence that 

11 reads as follows: ‘This in vitro clinical test was 

12 developed and first introduced prior to the date 

13 of enactment of the Verifying Accurate Lead14 ing-edge IVCT Development Act of 2021 and 

15 has not been reviewed by the Food and Drug 

16 Administration.’; and 

17 ‘‘(B) the developer of the test— 

18 ‘‘(i) maintains documentation dem19 onstrating that the test meets and con20 tinues to meet the criteria set forth in 

21 paragraph (2); and 

22 ‘‘(ii) makes such documentation avail23 able to the Secretary upon request. 


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1 ‘‘(2) CRITERIA FOR EXEMPTION.—An in vitro 

2 clinical test is exempt as specified in paragraph (1) 

3 if the test— 

4 ‘‘(A)(i) was first offered for clinical use by 

5 such laboratory before the date of enactment of 

6 the Verifying Accurate Leading-edge IVCT De7 velopment Act of 2021; 

8 ‘‘(ii) was developed by a clinical laboratory 

9 for which a certificate was in effect under sec10 tion 353 of the Public Health Service Act that 

11 meets the requirements under such section 353 

12 for performing high-complexity testing; and 

13 ‘‘(iii) is performed— 

14 ‘‘(I) in the same clinical laboratory in 

15 which it was developed; 

16 ‘‘(II) by another clinical laboratory for 

17 which a certificate is in effect under sec18 tion 353 within the same corporate organi19 zation and having common ownership by 

20 the same parent corporation; or 

21 ‘‘(III) by a laboratory within a public 

22 health laboratory network coordinated or 

23 managed by the Centers for Disease Con24 trol and Prevention; 


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1 ‘‘(B) does not have in effect an approval 

2 under section 515, a clearance under section 

3 510(k), an authorization under section 

4 513(f)(2), or an exemption under section 

5 520(m); and 

6 ‘‘(C) is not modified on or after the date 

7 of enactment of the Verifying Accurate Lead8 ing-edge IVCT Development Act of 2021 by its 

9 initial developer (or another person) in a man10 ner such that the test is a new in vitro clinical 

11 test under subsection (l). 

12 ‘‘(3) MODIFICATIONS.—In the case of a modi13 fication to an in vitro clinical test that is exempt as 

14 specified in paragraph (1) or such modification is 

15 otherwise not subject to premarket review pursuant 

16 to section 587A(l), the test continues to qualify for 

17 such exemption if the person modifying such test— 

18 ‘‘(A) documents each such modification 

19 and maintains a summary of the basis for such 

20 determination; and 

21 ‘‘(B) provides such documentation and 

22 summary to the Secretary upon request or in23 spection. 

24 ‘‘(d) TESTS EXEMPT FROM SECTION 510(k).— 


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

2 exempt from premarket review under section 587B 

3 and may be lawfully marketed subject to the other 

4 applicable requirements of this Act, if the in vitro 

5 clinical test— 

6 ‘‘(A)(i) was offered for clinical use prior to 

7 the date of enactment of the Verifying Accurate 

8 Leading-edge IVCT Development Act of 2021; 

9 and 

10 ‘‘(ii) immediately prior to such date of en11 actment was exempt pursuant to subsection (l) 

12 or (m)(2) of section 510 from the requirements 

13 for submission of a report under section 510(k); 

14 or 

15 ‘‘(B)(i) was not offered for clinical use 

16 prior to such date of enactment; 

17 ‘‘(ii) is not a test platform; and 

18 ‘‘(iii) falls within a category of tests that 

19 was exempt from the requirements for submis20 sion of a report under section 510(k) as of such 

21 date of enactment (including class II devices 

22 and excluding class I devices described in sec23 tion 510(l)). 

24 ‘‘(2) EFFECT ON SPECIAL CONTROLS.—For any 

25 in vitro clinical test, or category of in vitro clinical 


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1 tests, that is exempt from premarket review based 

2 on the criteria in paragraph (2), any special control 

3 that applied to a device within a predecessor cat4 egory immediately prior to the date of enactment of 

5 Verifying Accurate Leading-edge IVCT Development 

6 Act of 2021 shall be deemed a mitigating measure 

7 applicable under section 587E to an in vitro clinical 

8 test within the successor category, except to the ex9 tent such mitigating measure is withdrawn or 

10 changed in accordance with section 587E. 

11 ‘‘(3) NEAR-PATIENT TESTING.—Not later than 

12 1 year after the date of enactment of the Verifying 

13 Accurate Leading-edge IVCT Development Act of 

14 2021, the Secretary shall issue draft guidance indi15 cating categories of tests that shall be exempt from 

16 premarket review under section 587B when offered 

17 for near-patient testing (point of care), which were 

18 not exempt from submission of a report under sec19 tion 510(k) pursuant to subsection (l) or (m)(2) of 

20 section 510 and regulations imposing limitations on 

21 exemption for in vitro devices intended for near-pa22 tient testing (point of care). 

23 ‘‘(e) LOW-RISK TESTS.— 

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

25 exempt from premarket review under section 587B 


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1 and may be lawfully marketed subject to the other 

2 applicable requirements of this Act, including section 

3 587I(b)(6), if such test meets the definition of low4 risk under section 587. 

5 ‘‘(2) LIST OF LOW-RISK TESTS.— 

6 ‘‘(A) IN GENERAL.—The Secretary shall 

7 maintain, and make publicly available on the 

8 website of the Food and Drug Administration, 

9 a list of in vitro clinical tests, and categories of 

10 in vitro clinical tests, that are low-risk in vitro 

11 clinical tests for purposes of the exemption 

12 under this subsection. 

13 ‘‘(B) INCLUSION.—The list under subpara14 graph (A) shall consist of— 

15 ‘‘(i) all in vitro clinical tests and cat16 egories of in vitro clinical tests that are ex17 empt from premarket review pursuant to 

18 subsection (d)(1) or (d)(3); and 

19 ‘‘(ii) all in vitro clinical tests and cat20 egories of in vitro clinical tests that are 

21 designated by the Secretary pursuant to 

22 subparagraph (C) as low-risk for purposes 

23 of this subsection. 

24 ‘‘(C) DESIGNATION OF TESTS AND CAT25 EGORIES.—Without regard to subchapter II of 


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1 chapter 5 of title 5, United States Code, the 

2 Secretary may designate, in addition to the 

3 tests and categories described in subparagraph 

4 (B)(i), additional in vitro clinical tests, and cat5 egories of in vitro clinical tests, as low-risk in 

6 vitro clinical tests for purposes of the exemption 

7 under this subsection. The Secretary may make 

8 such a designation on the Secretary’s own ini9 tiative or in response to a request by any per10 son. In making such a designation for a test or 

11 category of tests, the Secretary shall consider— 

12 ‘‘(i) whether the test, or category of 

13 tests, is low-risk; and 

14 ‘‘(ii) such other factors as the Sec15 retary determines to be relevant to the pro16 tection of the public health. 

17 ‘‘(f) MANUAL TESTS.— 

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

19 exempt from all requirements of this subchapter if 

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

21 of direct, manual observation, without the use of 

22 automated instrumentation or software for inter23 mediate or final interpretation, by a qualified labora24 tory professional, and such in vitro clinical test— 


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1 ‘‘(A) is designed, manufactured, and used 

2 within a single clinical laboratory for which a 

3 certificate is in effect under section 353 of the 

4 Public Health Service Act that meets the re5 quirements under section 353 for performing 

6 high-complexity testing; 

7 ‘‘(B) is not a high-risk test, or is a high8 risk test that the Secretary has determined 

9 meets at least one condition in paragraph (2) 

10 and is otherwise appropriate for this exemption; 

11 and 

12 ‘‘(C) is not intended for testing donors, do13 nations, and recipients of blood, blood compo14 nents, human cells, tissues, cellular-based prod15 ucts, or tissue-based products. 

16 ‘‘(2) HIGH-RISK TEST LIMITATION OR CONDI17 TION.—A high-risk test may be exempt under para18 graph (1) from the requirements of this subchapter 

19 only if— 

20 ‘‘(A) no component or part of such test, in21 cluding any reagent, is introduced into inter22 state commerce under the exemption under sub23 section (b)(1) (relating to components or parts 

24 intended for further development), and any ar25 ticle for taking or deriving specimens from the 


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1 human body used in conjunction with the test 

2 remains subject to the requirements of this sub3 chapter; or 

4 ‘‘(B) the test has been developed in accord5 ance with the applicable test design and quality 

6 requirements under section 587J. 

7 ‘‘(g) HUMANITARIAN TEST EXEMPTION.— 

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

9 exempt from premarket review under section 587B 

10 and may be lawfully marketed subject to the other 

11 applicable requirements of this Act, if— 

12 ‘‘(A) such in vitro clinical test is intended 

13 for use for a disease or condition for which no 

14 more than 10,000 (or such other number deter15 mined by the Secretary) individuals would be 

16 subject to negative or positive diagnosis by such 

17 test in the United States per year; and 

18 ‘‘(B) the developer of the test— 

19 ‘‘(i) maintains documentation (which 

20 may include literature citations in special21 ized medical journals, textbooks, special22 ized medical society proceedings, govern23 mental statistics publications, or, if no 

24 such studies or literature citations exist, 

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1 search or surveys) demonstrating that such 

2 test meets and continues to meet the cri3 teria described in this paragraph; and 

4 ‘‘(ii) makes such documentation avail5 able to the Secretary upon request. 

6 ‘‘(2) CROSS-REFERENCED TESTS.—In order to 

7 be eligible for an exemption under this subsection, 

8 the developer of a cross-referenced test shall submit 

9 a request under section 587H for informal feedback. 

10 ‘‘(h) CUSTOM TESTS AND LOW-VOLUME TESTS.—An 

11 in vitro clinical test is exempt from premarket review 

12 under section 587B, the quality requirements under sec13 tion 587J, and the notification requirements under section 

14 587I, and may be lawfully marketed subject to the other 

15 applicable requirements of this Act, if— 

16 ‘‘(1) such in vitro clinical test— 

17 ‘‘(A) is a low-volume test performed in a 

18 laboratory in which it was developed or devel19 oped in a laboratory within the same corporate 

20 organization with the laboratory in which such 

21 test is performed and is administered to no 

22 more than 5 patients per year, unless otherwise 

23 determined by the Secretary; or 

24 ‘‘(B) is a custom test developed or modi25 fied to diagnose a unique pathology or physical 


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1 condition of a specific patient for which no 

2 other in vitro clinical test is commercially avail3 able in the United States, and is— 

4 ‘‘(i) not intended for use with respect 

5 to other patients; and 

6 ‘‘(ii) after the development of the cus7 tom test, not included in any test menu, 

8 template test report, or other promotional 

9 materials, and not otherwise advertised; 

10 and 

11 ‘‘(2) the developer of the test— 

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

14 to meet the applicable criteria described in 

15 paragraph (1); 

16 ‘‘(B) makes such documentation, such as a 

17 prescription order requesting the custom test 

18 for an individual patient, available to the Sec19 retary upon request; and 

20 ‘‘(C) informs the Secretary, on an annual 

21 basis, in a manner prescribed by the Secretary 

22 by guidance, that such test was introduced into 

23 interstate commerce. 

24 ‘‘(i) PUBLIC HEALTH SURVEILLANCE ACTIVITIES.— 


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1 ‘‘(1) IN GENERAL.—The provisions of this sub2 chapter shall not apply to a test intended by the de3 veloper to be used solely for public health surveil4 lance activities, including the collection and testing 

5 of information or biospecimens, conducted, sup6 ported, requested, ordered, required, or authorized 

7 by a public health authority. 

8 ‘‘(2) LIMITATION.—The public health surveil9 lance activities described in paragraph (1)— 

10 ‘‘(A) are limited to activities necessary to 

11 allow a public health authority to identify, mon12 itor, assess, or investigate potential public 

13 health signals, onsets of disease outbreaks, or 

14 conditions of public health importance (includ15 ing trends, risk factors, patterns in diseases, 

16 and increases in injuries from using consumer 

17 products); and 

18 ‘‘(B) include activities associated with pro19 viding timely situational awareness and priority 

20 setting during the course of a threat to the pub21 lic health (including natural or man-made dis22 asters and deliberate attacks on the United 

23 States). 

24 ‘‘(3) EXCLUSION.—An in vitro clinical test is 

25 not excluded from the provisions of this subchapter 


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1 if such test is intended for use in making clinical de2 cisions for individual patients. 

3 ‘‘(j) LAW ENFORCEMENT OR EMPLOYER TESTING.— 

4 An in vitro clinical test that is intended solely for use in 

5 forensic analysis, law enforcement activity, or employment 

6 purposes is exempt from the requirements of this Act. An 

7 in vitro clinical test that is intended for use in making 

8 clinical decisions for individual patients, or whose individ9 ually identifiable results may be reported back to an indi10 vidual patient or the patient’s health care provider, even 

11 if also intended for law enforcement or employment testing 

12 purposes, is not intended solely for use in law enforcement 

13 or employment testing for purposes of this subsection. 

14 ‘‘(k) IN VITRO CLINICAL TESTS UNDER A TECH15 NOLOGY CERTIFICATION ORDER.—An in vitro clinical test 

16 that is within the scope of a technology certification order, 

17 as described in section 587D(a), is exempt from premarket 

18 review under section 587B. 

19 ‘‘(l) MODIFIED TESTS.— 

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

21 that is modified, by the initial developer of the test 

22 or a different person, is a new in vitro clinical test 

23 subject to the requirements of this subchapter if the 

24 modification— 


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1 ‘‘(A) affects the analytical or clinical valid2 ity of such test; 

3 ‘‘(B) causes the test to no longer comply 

4 with applicable mitigating measures under sec5 tion 587E or restrictions under section 587N; 

6 or 

7 ‘‘(C) as applicable, affects the safety of an 

8 article for taking or deriving specimens from 

9 the human body for a purpose described in sec10 tion 201(ss)(1). 

11 ‘‘(2) EXEMPTIONS.—Notwithstanding para12 graph (1), an in vitro clinical test that is modified 

13 by the initial developer of the test or a different per14 son is not a new in vitro clinical test if the modifica15 tion— 

16 ‘‘(A) is a software update that does not 

17 have an adverse effect on the analytical or clin18 ical validity or result in an increased risk to pa19 tients and consumers; 

20 ‘‘(B) is made pursuant to methods or cri21 teria included in the change protocol premarket 

22 submission, amendment, or supplement ap23 proved by the Secretary for the in vitro clinical 

24 test being modified; 


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1 ‘‘(C) is a labeling change that is appro2 priate to address patient or user harm; or 

3 ‘‘(D) is a specimen-related modification 

4 that— 

5 ‘‘(i) is made to extend specimen sta6 bility; or 

7 ‘‘(ii) aligns with the data and infor8 mation submitted in an approved applica9 tion for premarket review under section 

10 587B or a technology certification order 

11 issued under section 587D. 

12 ‘‘(3) DOCUMENTATION.—When a person modi13 fies an in vitro clinical test that was developed by 

14 another person, such modified test is exempt from 

15 the requirements of this subchapter provided that 

16 such person— 

17 ‘‘(A) documents the modification that was 

18 made and the basis for determining that the 

19 modification, considering the changes individ20 ually and collectively, was not a type of modi21 fication described in paragraph (1); and 

22 ‘‘(B) provides such documentation to the 

23 Secretary upon request or inspection. 


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1 ‘‘(m) INVESTIGATIONAL USE.—An in vitro clinical 

2 test for investigational use is exempt from the require3 ments of this Act, except as provided in section 587R. 

4 ‘‘(n) TRANSFER OR SALE OF IN VITRO CLINICAL

5 TESTS.— 

6 ‘‘(1) TRANSFER AND ASSUMPTION OF REGU7 LATORY OBLIGATIONS.—If ownership of an in vitro 

8 clinical test is sold or transferred in such manner 

9 that the developer transfers the regulatory submis10 sions and obligations applicable under this sub11 chapter with respect to the test, the transferee or 

12 purchaser becomes the developer of the test and 

13 shall have all regulatory obligations applicable to 

14 such a test under this subchapter. The transferee or 

15 purchaser shall update the registration and listing 

16 information under section 587I for the in vitro clin17 ical test. 

18 ‘‘(2) TRANSFER OR SALE OF PREMARKET AP19 PROVAL.— 

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

21 of an in vitro clinical test transfers or sells the 

22 approval of the in vitro clinical test, the trans23 feror or seller shall— 

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

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1 istration and listing information under sec2 tion 587I for the in vitro clinical test; and 

3 ‘‘(ii) submit a supplemental applica4 tion if required under section 587B(h). 

5 ‘‘(B) EFFECTIVE DATE OF APPROVAL

6 TRANSFER.—A transfer or sale described in 

7 subparagraph (A) shall become effective upon 

8 completion of a transfer or sale described in 

9 paragraph (1) or the approval of a supple10 mental application under section 587B(h) if re11 quired, whichever is later. The transferee or 

12 purchaser shall update the registration and list13 ing information under section 587I for the in 

14 vitro clinical test within 15 calendar days of the 

15 effective date of the transfer or sale. 

16 ‘‘(3) TRANSFER OR SALE OF TECHNOLOGY CER17 TIFICATION.— 

18 ‘‘(A) REQUIREMENTS FOR TRANSFER OR

19 SALE OF TECHNOLOGY CERTIFICATION.—An 

20 unexpired technology certification can be trans21 ferred or sold if the transferee or purchaser— 

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

23 587D(b)(1); and 

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

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1 quirements, processes and procedures 

2 under the scope of technology certification, 

3 and scope of the technology certification 

4 identified in the applicable technology cer5 tification order. 

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

7 of an in vitro clinical test transfers or sells a 

8 technology certification order that has not ex9 pired, the transferor or seller shall submit a no10 tice of the transfer or sale to the Secretary and 

11 shall update the registration and listing infor12 mation under section 587I for all in vitro clin13 ical tests covered by the technology certifi14 cation. 

15 ‘‘(C) EFFECTIVE DATE OF TECHNOLOGY

16 CERTIFICATION TRANSFER.—The transfer of a 

17 technology certification shall become effective 

18 upon completion of a transfer or sale described 

19 in subparagraph (A). The transferee or pur20 chaser shall update the registration and listing 

21 information under section 587I for the in vitro 

22 clinical test within 30 calendar days of the ef23 fective date of the technology certification 

24 transfer. 


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1 ‘‘(D) NEW TECHNOLOGY CERTIFICATION

2 REQUIRED.—If the requirements of subpara3 graph (A)(ii) are not met, the technology cer4 tification order may not be transferred and the 

5 transferee or purchaser of an in vitro clinical 

6 test is required to submit an application for 

7 technology certification and obtain a technology 

8 certification order prior to offering the test for 

9 clinical use. 

10 ‘‘(o) GENERAL LABORATORY EQUIPMENT.—Any in11 strument that does not produce an analytical result, and 

12 that functions as a component of pre-analytical procedures 

13 related to in vitro clinical tests, is not subject to the re14 quirements of this subchapter, provided that— 

15 ‘‘(1) the instrument is operating in a clinical 

16 laboratory that is certified under section 353 of the 

17 Public Health Service Act; and 

18 ‘‘(2) the instrument can be serviced by the 

19 manufacturer of such instrument or, if that manu20 facturer is no longer in business, a third party with 

21 the ability to service such instrument. 

22 ‘‘(p) INSTRUMENT FAMILIES.—In the case of an in23 strument family, premarket approval under section 

24 587B(d) of one version of the in vitro clinical test is re25 quired, and previous and updated versions of the same test 


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1 within such instrument family shall be deemed to be sub2 ject to the approval pursuant to that section, unless the 

3 Secretary determines otherwise, as set forth in guidance. 

4 ‘‘(q) GENERAL EXEMPTION AUTHORITY.—The Sec5 retary may, by order published in the Federal Register 

6 following notice and an opportunity for comment, exempt 

7 a class of persons from any section under this subchapter 

8 upon a finding that such exemption is appropriate for the 

9 protection of the public health and other relevant consider10 ations. 

11 ‘‘(r) REGULATIONS.—The Secretary may issue regu12 lations to implement this subchapter. 

13 ‘‘SEC. 587B. PREMARKET REVIEW. 

14 ‘‘(a) IN GENERAL.—No person shall introduce or de15 liver for introduction into interstate commerce any in vitro 

16 clinical test, unless— 

17 ‘‘(1) an approval of an application filed pursu18 ant to subsection (c) or (d) is effective with respect 

19 to test; or 

20 ‘‘(2) the test is exempt under section 587A 

21 from premarket review under this section. 

22 ‘‘(b) TRANSPARENCY AND PREDICTABILITY.— 

23 ‘‘(1) PRE-SUBMISSION MEETING OR REQUEST

24 FOR INFORMAL FEEDBACK.—Pursuant to section 

25 587H, prior to filing an application under subsection 


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1 (c) or (d), any person may request a meeting or 

2 written correspondence with the Secretary to discuss 

3 the eligibility of an in vitro clinical test for pre4 market review or other information related to the fil5 ing of an application. The Secretary shall respond to 

6 such request within 45 calendar days. 

7 ‘‘(2) STREAMLINING OF APPLICATIONS.— 

8 ‘‘(A) PREMARKET APPLICATION AND

9 TECHNOLOGY CERTIFICATION.—If a person 

10 files a premarket application under this section 

11 and provides any additional documentation re12 quired under section 587D, the in vitro clinical 

13 test that is the subject of the application may 

14 be utilized as the representative test reviewed 

15 by the Secretary to provide an approval for 

16 both a premarket application under this section 

17 and a technology certification order under sec18 tion 587D. 

19 ‘‘(B) REPRESENTATIVE ASSAYS FOR PRE20 MARKET APPROVAL.—With respect to a tech21 nology certification application filed under sec22 tion 587D, the representative test, as described 

23 in subparagraph (A), used to issue a technology 

24 certification order under section 587D shall be 


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1 deemed a test with premarket approval under 

2 this section. 

3 ‘‘(c) APPLICATION.— 

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

5 Secretary an application for premarket approval of 

6 an in vitro clinical test. 

7 ‘‘(2) APPLICATION CONTENT.—An application 

8 submitted under paragraph (1) with respect to an in 

9 vitro clinical test shall include the following, in such 

10 format as the Secretary specifies: 

11 ‘‘(A) General information regarding the in 

12 vitro clinical test, including— 

13 ‘‘(i) the name and address of the ap14 plicant; 

15 ‘‘(ii) the table of contents for the ap16 plication and the identification of the infor17 mation the applicant claims as trade secret 

18 or confidential commercial or financial in19 formation; 

20 ‘‘(iii) a description of the test’s in21 tended use; 

22 ‘‘(iv) an explanation regarding test 

23 function and any significant performance 

24 characteristics; and 


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1 ‘‘(v) an explanation of how the devel2 opment and validation activities support 

3 the test meeting the applicable standard. 

4 ‘‘(B) A summary of the data and informa5 tion in the application for the in vitro clinical 

6 test, including— 

7 ‘‘(i) a brief description of any existing 

8 alternative practices or procedures for di9 agnosing the disease or condition for which 

10 the in vitro clinical test is intended, as ap11 plicable; 

12 ‘‘(ii) a brief description of the foreign 

13 and domestic marketing history of the test, 

14 if any, including a list of all countries in 

15 which the test has been marketed and a 

16 list of all countries in which the test has 

17 been withdrawn from marketing for any 

18 reason related to the applicable standard 

19 of the in vitro clinical test, if known by the 

20 applicant; 

21 ‘‘(iii) a summary of the any studies 

22 submitted for such test, including a de23 scription of the objective of the study, a 

24 description of the experimental design of 

25 the study, a brief description of how the 


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1 data were collected and analyzed, a brief 

2 description of the results of the technical 

3 data submitted, and a brief description of 

4 any nonclinical or clinical studies; 

5 ‘‘(iv) a risk assessment of the test; 

6 and 

7 ‘‘(v) conclusions drawn from any stud8 ies described in clause (iii), including a dis9 cussion demonstrating that the data and 

10 information in the application constitute 

11 valid scientific evidence and meet the appli12 cable standard under section 587(2), an 

13 explanation of how the development and 

14 validation activities, as applicable, support 

15 that the test meets the applicable standard 

16 under section 587(2), and a discussion of 

17 any adverse effects of the test on health 

18 and proposals to mitigate those risks, if 

19 any. 

20 ‘‘(C) The signature of the person filing the 

21 premarket application or an authorized rep22 resentative. 

23 ‘‘(D) A bibliography of all published re24 ports reasonably known to the applicant related 

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1 mation relevant to the evaluation of the applica2 ble standard that may be met by such test. 

3 ‘‘(E) A statement that the applicant be4 lieves to the best of the applicant’s knowledge 

5 that all data and information submitted to the 

6 Secretary are truthful and accurate and that no 

7 material fact has been omitted in the applica8 tion. 

9 ‘‘(F) Except as provided under subsection 

10 (d), applicable information regarding the meth11 ods used in, or the facilities or controls used 

12 for, the development of the test to demonstrate 

13 compliance with the applicable quality require14 ments under section 587J. 

15 ‘‘(G) Information demonstrating compli16 ance with any relevant— 

17 ‘‘(i) mitigating measures under sec18 tion 587E; and 

19 ‘‘(ii) standards established or recog20 nized under section 514 prior to the date 

21 of enactment of the Verifying Accurate 

22 Leading-edge IVCT Development Act of 

23 2021, or, after applicable standards are es24 tablished or recognized under section 

25 587Q, with such standards. 


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1 ‘‘(H) Valid scientific evidence to support 

2 analytical and clinical validity of the test, which 

3 shall include— 

4 ‘‘(i) summary information for all sup5 porting validation studies performed; 

6 ‘‘(ii) raw data, such as tabulations of 

7 data and results as required under section 

8 814.20(b)(6)(ii) of title 21, Code of Fed9 eral Regulations (or any successor regula10 tions); 

11 ‘‘(iii) for nonclinical laboratory studies 

12 involving the test, a statement that studies 

13 were conducted in compliance with applica14 ble good laboratory practices; and 

15 ‘‘(iv) for investigations involving 

16 human subjects, statements that any clin17 ical investigation involving human subjects 

18 was conducted in compliance with applica19 ble— 

20 ‘‘(I) institutional review board 

21 regulations; 

22 ‘‘(II) informed consent regula23 tions; and 

24 ‘‘(III) investigational use require25 ments in section 587R. 


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1 ‘‘(I) To the extent the application seeks 

2 authorization to make modifications to the test 

3 within the scope of the approval, a change pro4 tocol that includes validation procedures and 

5 acceptance criteria for anticipated modifications 

6 that could be made to the test within the scope 

7 of the approval. 

8 ‘‘(J) Proposed labeling, in accordance with 

9 the requirements of section 587K. 

10 ‘‘(K) Such other data or information as 

11 the Secretary may require in accordance with 

12 the least burdensome requirements of sub13 section (j). 

14 ‘‘(3) GUIDANCE FOR PREMARKET AND SPECIAL

15 PREMARKET APPLICATIONS.—In accordance with 

16 section 5 of the Verifying Accurate Leading-edge 

17 IVCT Development Act of 2021, the Secretary shall 

18 issue draft guidance detailing the information to be 

19 provided in a premarket application and special pre20 market application under this section. The Secretary 

21 shall issue final guidance not later than 90 calendar 

22 days after the close of the comment period for such 

23 guidance. 

24 ‘‘(4) REFUSE TO FILE A PREMARKET OR SPE25 CIAL PREMARKET APPLICATION.—If, after receipt of 


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1 an application under this section, the Secretary re2 fuses to file such application, the Secretary shall 

3 provide to the developer, within 60 calendar days of 

4 receipt of such application, a description of the rea5 son for such refusal, and identify the information re6 quired, if any, to allow for the filing of the applica7 tion. 

8 ‘‘(5) SUBSTANTIVE REVIEW FOR DEFICIENT AP9 PLICATION.—If, after receipt of an application under 

10 this section, the Secretary determines that any por11 tion of such application is deficient, the Secretary 

12 shall provide to the applicant, within 75 calendar 

13 days of receipt of such application, a description of 

14 such deficiencies and identify the information re15 quired to correct such deficiencies. 

16 ‘‘(d) SPECIAL PREMARKET REVIEW.— 

17 ‘‘(1) IN GENERAL.—Any person may file with 

18 the Secretary an application for special premarket 

19 approval for— 

20 ‘‘(A) an instrument; 

21 ‘‘(B) a specimen receptacle; 

22 ‘‘(C) an in vitro clinical test eligible for a 

23 technology certification order under section 

24 587D; or 


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1 ‘‘(D) a first-of-a-kind test (unless it is a 

2 high-risk test), a direct-to-consumer test, or 

3 cross-referenced test that does not have miti4 gating measures. 

5 ‘‘(2) APPLICATION CONTENT.—An application 

6 under paragraph (1) shall include— 

7 ‘‘(A) the information required for applica8 tions submitted under subsection (c)(2), except 

9 that applications under paragraph (1) need not 

10 include— 

11 ‘‘(i) quality requirement information; 

12 or 

13 ‘‘(ii) raw data unless explicitly re14 quested by the Secretary; 

15 ‘‘(B) in the case of a specimen receptacle, 

16 safety information; and 

17 ‘‘(C) data, as applicable, to support soft18 ware validation, electromagnetic compatibility, 

19 and electrical safety, and information dem20 onstrating compliance with maintaining quality 

21 systems documentation. 

22 ‘‘(3) 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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1 587P need not occur unless requested by the Sec2 retary. 

3 ‘‘(e) INSTRUMENT FAMILY.—When an in vitro clin4 ical test has been approved, or is otherwise legally mar5 keted, for use on a specific approved or legally marketed 

6 instrument within an instrument family, a submission 

7 under this section shall not be required for that in vitro 

8 clinical test in order for it to be used on a new instrument 

9 within that instrument’s family. 

10 ‘‘(f) AMENDMENTS TO AN APPLICATION.— 

11 ‘‘(1) IN GENERAL.—An applicant may amend 

12 an original or supplemental application under sub13 section (c) or (d). 

14 ‘‘(2) REQUIRED AMENDMENT OR SUPPLE15 MENT.—An applicant shall amend or supplement an 

16 application submitted under subsection (c) or (d) if 

17 the applicant becomes aware of information that— 

18 ‘‘(A) could reasonably affect an evaluation 

19 of whether the applicable standard has been 

20 met; or 

21 ‘‘(B) could reasonably affect the statement 

22 of contraindications, warnings, precautions, and 

23 adverse reactions in the proposed labeling. 

24 ‘‘(3) REQUEST FOR AMENDMENT OR SUPPLE25 MENT.—The Secretary may request that an appliVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 cant amend or supplement an application under sub2 section (c) or (d) with any information necessary for 

3 review under this section. 

4 ‘‘(g) ACTION ON AN APPLICATION FOR PREMARKET

5 APPROVAL.— 

6 ‘‘(1) REVIEW.— 

7 ‘‘(A) DISPOSITION.—As promptly as pos8 sible, but not later than 90 calendar days after 

9 an application under subsection (c) is accepted 

10 for submission (unless the Secretary determines 

11 that an extension is necessary to review one or 

12 more major amendments to the application), or 

13 not later than 60 calendar days after an appli14 cation under subsection (d) is accepted for sub15 mission, the Secretary, after considering any 

16 applicable report and recommendations pursu17 ant to advisory committees under section 587G, 

18 or prior to the establishment of such advisory 

19 committees, any recommendations by a classi20 fication panel under section 513, shall issue an 

21 order approving the application, unless the Sec22 retary finds that the grounds for approval in 

23 paragraph (2) are not met. 

24 ‘‘(B) RELIANCE ON PROPOSED LABEL25 ING.—In determining whether to approve or 


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1 deny an application under paragraph (1), the 

2 Secretary shall rely on the intended use in3 cluded in the proposed labeling, provided that 

4 such labeling is not false or misleading based on 

5 a fair evaluation of all material facts. 

6 ‘‘(2) APPROVAL OF AN APPLICATION.— 

7 ‘‘(A) IN GENERAL.—The Secretary shall 

8 approve an application submitted under sub9 section (c) with respect to an in vitro clinical 

10 test if the Secretary finds that there is a rea11 sonable assurance that the applicable standard 

12 is met, and— 

13 ‘‘(i) except as provided under sub14 section (d), the applicant is in compliance 

15 with applicable quality requirements in sec16 tion 587J or as otherwise specified in a 

17 condition of approval, or maintains the 

18 documentation required to be in compli19 ance with such requirements if the appli20 cant is not required to submit such docu21 mentation as a part of the application 

22 under this section; 

23 ‘‘(ii) the application does not contain 

24 a false statement of material fact; 


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1 ‘‘(iii) based on a fair evaluation of all 

2 material facts, the proposed labeling is 

3 truthful and non-misleading and complies 

4 with the requirements of section 587K; 

5 ‘‘(iv) except as provided under sub6 section (d), the applicant permits, if re7 quested, authorized employees of the Food 

8 and Drug Administration and persons ac9 credited under section 587P an oppor10 tunity— 

11 ‘‘(I) to inspect at a reasonable 

12 time and in a reasonable manner the 

13 facilities and all pertinent equipment, 

14 finished and unfinished materials, 

15 containers, and labeling therein, in16 cluding all things (including records, 

17 files, papers, and controls) bearing on 

18 whether an in vitro clinical test is 

19 adulterated, misbranded, or otherwise 

20 in violation of this Act; and 

21 ‘‘(II) to view and to copy and 

22 verify all records pertinent to the ap23 plication and the in vitro clinical test; 

24 ‘‘(v) the test conforms with any appli25 cable performance standards under section 


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1 587Q and any applicable mitigating meas2 ures under section 587E; and 

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 requirements of this section. 

8 ‘‘(B) CONDITIONS OF APPROVAL.—An 

9 order approving an application pursuant to this 

10 paragraph may require conditions of approval 

11 for the in vitro clinical test, including conform12 ance with performance standards under section 

13 587Q and restrictions under section 587N. 

14 ‘‘(C) FIRST-OF-A-KIND TEST.—For a first15 of-a-kind in vitro clinical test, an order approv16 ing an application pursuant to this paragraph— 

17 ‘‘(i) may impose requirements for 

18 tests with the same indications for use, in19 cluding conformance with performance 

20 standards under section 587Q and miti21 gating measures under section 587E, and 

22 comply with restrictions under section 

23 587N; and 

24 ‘‘(ii) shall indicate whether subsequent 

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1 tended use may meet an exemption set 

2 forth in section 587A. 

3 ‘‘(D) PUBLICATION.—The Secretary shall 

4 publish each order approving an application 

5 pursuant to this paragraph on the public 

6 website of the Food and Drug Administration 

7 and make publicly available a summary of the 

8 data used to grant the approval, except to the 

9 extent the Secretary determines that such 

10 order— 

11 ‘‘(i) contains commercially confidential 

12 or trade secret information; or 

13 ‘‘(ii) relates to national security or 

14 countermeasures is restricted from disclo15 sure pursuant to statutory provisions other 

16 than this section. 

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

18 whose application submitted under subsection (c) or 

19 (d) has been denied approval may, by petition filed 

20 not more than 60 calendar days after the date on 

21 which the applicant receives notice of such denial, 

22 obtain review of the denial in accordance with sec23 tion 587O. 

24 ‘‘(h) SUPPLEMENTS TO AN APPLICATION.— 


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

2 any modification to an in vitro clinical test, the hold3 er of the application approved under subsection (c) 

4 or (d) for such test shall perform risk analyses in 

5 accordance with section 587J, unless such modifica6 tion is included in the change protocol submitted by 

7 the applicant and approved under this section or ex8 empt under section 587A(l). 

9 ‘‘(2) SUPPLEMENT REQUIREMENT.— 

10 ‘‘(A) IN GENERAL.—Except as provided in 

11 subparagraph (B), or otherwise specified by the 

12 Secretary, the holder of the application ap13 proved under subsection (g) for an in vitro clin14 ical test shall submit to the Secretary and re15 ceive approval of a supplement before imple16 menting a modification to the test, unless such 

17 modification is exempt under section 587A(l). 

18 ‘‘(B) ADJUSTMENTS TO CHANGE PRO19 TOCOL.—A person may submit under this para20 graph a supplemental application adjusting the 

21 change protocol of the test at any time after the 

22 initial filing of an application under subsection 

23 (c) or (d). 

24 ‘‘(C) EXCEPTIONS.—Subject to subpara25 graphs (D) and (E), and so long as the holder 


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1 of an approved application submitted under 

2 subsection (c) or (d) for an in vitro clinical test 

3 does not add a manufacturing site, or change 

4 activities at an existing manufacturing site, 

5 with respect to the test, the holder may, with6 out prior approval of a supplement, implement 

7 the following modifications to the test: 

8 ‘‘(i) Modifications included in and im9 plemented in accordance with an approved 

10 change protocol under subsection (c)(2)(I). 

11 ‘‘(ii) Modifications that do not 

12 change— 

13 ‘‘(I) the analytical or clinical va14 lidity of the test; 

15 ‘‘(II) the intended use of the test 

16 unless provided under an approved 

17 change protocol under subsection 

18 (c)(2)(I); or 

19 ‘‘(III) the safety of the specimen 

20 receptacles. 

21 ‘‘(iii) Labeling changes to appro22 priately address a safety concern. 

23 ‘‘(iv) Modifications that are exempt 

24 under section 587A(l). 


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1 ‘‘(D) REPORTING FOR CHANGE PROTOCOL

2 MODIFICATIONS.—As a component of the report 

3 required under subsection (k), the holder of an 

4 application approved under subsection (g) for 

5 an in vitro clinical test shall— 

6 ‘‘(i) report any modification to the 

7 test described in clause (i) or (ii) of sub8 paragraph (C) in the next annual report 

9 for the test under subsection (k) following 

10 the date on which the test, with such modi11 fication, is introduced into interstate com12 merce; and 

13 ‘‘(ii) include in such report— 

14 ‘‘(I) a description of the modi15 fication; and 

16 ‘‘(II) as applicable, a summary of 

17 the analytical validity and clinical va18 lidity of the test, as modified, and any 

19 changes to acceptance criteria. 

20 ‘‘(E) REPORTING FOR OTHER CATEGORY

21 OF EXCEPTIONS.—The holder of the application 

22 approved under subsection (c) or (d) for an in 

23 vitro clinical test shall— 

24 ‘‘(i) report to the Secretary any modi25 fication to the test described in clause (iii) 


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1 of subparagraph (C) not more than 60 

2 days after the date on which the test, with 

3 the modification, is introduced into inter4 state commerce; and 

5 ‘‘(ii) include in the report— 

6 ‘‘(I) a summary of the relevant 

7 change or changes; 

8 ‘‘(II) the rationale for imple9 menting such change or changes; and 

10 ‘‘(III) a description of how the 

11 change or changes were evaluated. 

12 ‘‘(F) REQUEST FOR SUPPLEMENT.—Upon 

13 review of the information received under sub14 paragraph (D) and a finding that the relevant 

15 modification is inconsistent with the standard 

16 specified under subparagraph (C), the Secretary 

17 may require a supplement under subparagraph 

18 (A). If the Secretary determines that a supple19 ment under subparagraph (A) is required, the 

20 Secretary shall notify the applicant of such de21 termination. Such notification shall include a 

22 justification for the submission of a supplement. 

23 Prior to the submission of a supplement under 

24 this subparagraph, the applicant may request a 

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1 cy feedback as to the necessity of such supple2 mental filing. The Secretary shall respond to 

3 such meeting request within 30 calendar days 

4 of receipt. 

5 ‘‘(3) CONTENTS OF SUPPLEMENT.—Unless oth6 erwise specified by the Secretary, a supplement 

7 under this subsection shall include— 

8 ‘‘(A) for modifications other than manufac9 turing site changes— 

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

11 ‘‘(ii) data to demonstrate that the ap12 plicable standard is met; 

13 ‘‘(iii) acceptance criteria; and 

14 ‘‘(iv) any revised labeling; and 

15 ‘‘(B) for manufacturing site changes— 

16 ‘‘(i) the information listed in subpara17 graph (A); and 

18 ‘‘(ii) information regarding the meth19 ods used in, or the facilities or controls 

20 used for, the development of the test to 

21 demonstrate compliance with the applicable 

22 quality requirements under section 587J. 

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

24 require, when necessary, data to evaluate a modifica25 tion to an in vitro clinical test that is in addition to 


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1 the data otherwise required under the preceding 

2 paragraphs if the data request is in accordance with 

3 the least burdensome requirements under subsection 

4 (j). 

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

6 approving a supplement under this subsection, the 

7 Secretary may require conditions of approval for the 

8 in vitro clinical test, including compliance with re9 strictions under section 587N and conformance to 

10 performance standards under section 587Q. 

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

12 a supplement under this subsection if— 

13 ‘‘(A) the data demonstrate that the modi14 fied in vitro clinical test meets the applicable 

15 standard; and 

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

17 under subsection (g) for the test has dem18 onstrated compliance with applicable quality 

19 and inspection requirements, as applicable and 

20 appropriate. 

21 ‘‘(7) PUBLICATION.—The Secretary shall pub22 lish on the public website of the Food and Drug Ad23 ministration notice of any order approving a supple24 ment under this subsection, except that such publi25 cation shall exclude— 


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1 ‘‘(A) commercial confidential or trade se2 cret information; and 

3 ‘‘(B) any other information that the Sec4 retary determines to relate to national security 

5 or countermeasures or to be restricted from dis6 closure pursuant to another provision of law. 

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

8 supplement under this subsection has been denied 

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

10 calendar day after the date upon which the applicant 

11 receives notice of such denial, obtain review of the 

12 denial in accordance with section 587O. 

13 ‘‘(i) WITHDRAWAL AND TEMPORARY SUSPENSION OF

14 APPROVAL.— 

15 ‘‘(1) ORDER WITHDRAWING APPROVAL.— 

16 ‘‘(A) IN GENERAL.—The Secretary may, 

17 within 10 calendar days of providing due notice 

18 and an opportunity for an informal hearing to 

19 the holder of an approved application for an in 

20 vitro clinical test under this section, issue an 

21 order withdrawing approval of the application if 

22 the Secretary finds that— 

23 ‘‘(i) the grounds for approval under 

24 subsection (g) are no longer met; or 


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1 ‘‘(ii) there is a reasonable likelihood 

2 that the test would cause death or serious 

3 adverse health consequences, including by 

4 causing the absence, delay, or discontinu5 ation of life-saving or life sustaining med6 ical treatment. 

7 ‘‘(B) CONTENT.—An order under subpara8 graph (A) withdrawing approval of an applica9 tion shall state each ground for withdrawal and 

10 shall notify the holder of such application 60 

11 calendar days prior to issuing such order. 

12 ‘‘(C) PUBLICATION.—The Secretary shall 

13 publish any order under subparagraph (A) on 

14 the public website of the Food and Drug Ad15 ministration, except that such publication shall 

16 exclude— 

17 ‘‘(i) commercial confidential or trade 

18 secret information; and 

19 ‘‘(ii) any other information that the 

20 Secretary determines to relate to national 

21 security or countermeasures or to be re22 stricted from disclosure pursuant to an23 other provision of law. 

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

25 after providing due notice and an opportunity for an 


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1 informal hearing to the holder of an approved appli2 cation for an in vitro clinical test under this section, 

3 the Secretary determines there is a reasonable likeli4 hood that the in vitro clinical test would cause death 

5 or serious adverse health consequences, including by 

6 causing the absence, delay, or discontinuation of life7 saving or life-sustaining medical treatment, the Sec8 retary shall by order temporarily suspend the ap9 proval of the application. If the Secretary issues 

10 such an order, the Secretary shall proceed expedi11 tiously under paragraph (1) to withdraw approval of 

12 such application. 

13 ‘‘(j) LEAST BURDENSOME REQUIREMENTS.— 

14 ‘‘(1) IN GENERAL.—In carrying out this sub15 chapter, the Secretary shall consider the least bur16 densome means necessary to provide a reasonable 

17 assurance of analytical and clinical validity, or appli18 cable standard, and other regulatory requirements, 

19 as determined by the Secretary. 

20 ‘‘(2) NECESSARY DEFINED.—For purposes of 

21 paragraph (1) and paragraph (3), the term ‘nec22 essary’ means the minimum required information 

23 that would support a determination by the Secretary 

24 that the application provides a reasonable assurance 

25 of analytical and clinical validity, or other applicable 


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1 standard or regulatory requirement, as determined 

2 by the Secretary. 

3 ‘‘(3) CONSIDERATION OF ROLE OF

4 POSTMARKET INFORMATION.—For purposes of this 

5 subsection, the Secretary shall consider the role of 

6 postmarket information in determining the least bur7 densome appropriate means necessary to dem8 onstrate that the applicable standard and other reg9 ulatory requirements have been met. 

10 ‘‘(k) ANNUAL REPORT.— 

11 ‘‘(1) IN GENERAL.—Unless the Secretary speci12 fies otherwise, the holder of an approved application 

13 under this section shall submit an annual report 

14 each year at a time designated by the Secretary in 

15 the approval order. Such report shall— 

16 ‘‘(A) identify all modifications required to 

17 be reported that an approved application holder 

18 has made to any test that is covered by the ap19 proval order, including any modification that 

20 requires a supplement under subsection (h)(2); 

21 and 

22 ‘‘(B) include any other information re23 quired by the Secretary. 

24 ‘‘(2) EXCEPTION.—The annual reporting re25 quirement in paragraph (1) shall not apply to in 


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1 vitro clinical tests that are deemed to have a pre2 market approval based on a prior approval under 

3 section 515(c), clearance under section 510(k), or 

4 authorization under section 513(f) of this Act, or 

5 that are grandfathered under 587A(c). 

6 ‘‘(l) SERVICE OF ORDERS.—Orders of the Secretary 

7 under this section with respect to applications under sub8 section (c) or (d) or supplements under subsection (h) 

9 shall be served— 

10 ‘‘(1) in person by any officer or employee of the 

11 Department of Health and Human Services des12 ignated by the Secretary; or 

13 ‘‘(2) by mailing the order by registered mail or 

14 certified mail or electronic equivalent addressed to 

15 the applicant at the last known address in the 

16 records of the Secretary. 

17 ‘‘SEC. 587C. BREAKTHROUGH IN VITRO CLINICAL TESTS. 

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

19 to encourage the Secretary to apply efficient and flexible 

20 approaches to expedite the development of, and prioritize 

21 the review of, in vitro clinical tests that represent break22 through technologies, and to provide the Secretary with 

23 sufficient authority to do so. 

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

25 shall establish a program to expedite the development of, 


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

2 tests. 

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

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

5 test that— 

6 ‘‘(1) provides or enables more effective treat7 ment or diagnosis of life-threatening or irreversibly 

8 debilitating human disease or conditions compared 

9 to existing approved or precertified alternatives; and 

10 ‘‘(2) is a test— 

11 ‘‘(A) that represents a breakthrough tech12 nology; 

13 ‘‘(B) for which no approved or precertified 

14 alternative exists; 

15 ‘‘(C) that offers a clinically meaningful ad16 vantage over existing approved or precertified 

17 alternatives, including the potential, compared 

18 to existing approved or precertified alternatives, 

19 to reduce or eliminate the need for hospitaliza20 tion, improve patient quality of life, facilitate 

21 patients’ ability to manage their own care (such 

22 as through self-directed personal assistance), or 

23 establish long-term clinical efficiencies; or 

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

25 interest of patients or public health. 


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1 ‘‘(d) DESIGNATION.— 

2 ‘‘(1) REQUEST.—To receive breakthrough ap3 proval under this section, an applicant may request 

4 that the Secretary designate the in vitro clinical test 

5 for expedited development and priority review. Any 

6 such request for designation may be made at any 

7 time prior to the submission of an application under 

8 section 587B, and shall include information dem9 onstrating that the test is eligible for designation 

10 under subsection (c). 

11 ‘‘(2) DETERMINATION.—Not later than 60 cal12 endar days after the receipt of a request under para13 graph (1), the Secretary shall determine whether the 

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

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

16 Secretary determines that the test meets the criteria, 

17 the Secretary shall designate the test for expedited 

18 development and priority review. 

19 ‘‘(3) REVIEW.—Review of a request under para20 graph (1) shall be undertaken by a team that is 

21 composed of experienced staff and senior managers 

22 of the Food and Drug Administration. 

23 ‘‘(4) WITHDRAWAL.— 

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

25 in vitro clinical test under this subsection is 


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1 deemed to be withdrawn, and such in vitro clin2 ical test shall no longer be eligible for designa3 tion under this section, if an application for ap4 proval under section 587B is denied. Such test 

5 shall be eligible for designation upon a new re6 quest for such designation. 

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

8 withdraw a designation granted under this sub9 section based on the subsequent approval or 

10 technology certification of another test that— 

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

12 or 

13 ‘‘(ii) was given priority review under 

14 section 515B. 

15 ‘‘(e) ACTIONS.—For purposes of expediting the devel16 opment and review of in vitro clinical tests under this sec17 tion, the Secretary may take the actions and additional 

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

19 of section 515B(e) when reviewing such tests. Any ref20 erence or authorization in section 515B(e) with respect 

21 to a device shall be deemed a reference or authorization 

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

23 section. 

24 ‘‘(f) GUIDANCE.— 


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1 ‘‘(1) IN GENERAL.—Not later than one year 

2 after the date of enactment of the Verifying Accu3 rate Leading-edge IVCT Development Act of 2021, 

4 the Secretary shall issue draft guidance on the im5 plementation of this section. Such guidance shall— 

6 ‘‘(A) set forth the process by which a per7 son may seek a designation under subsection 

8 (d); 

9 ‘‘(B) provide a template for request under 

10 subsection (d); 

11 ‘‘(C) identify the criteria the Secretary will 

12 use in evaluating a request for designation; and 

13 ‘‘(D) identify the criteria and processes the 

14 Secretary will use to assign a team of staff, in15 cluding team leaders, to review in vitro clinical 

16 tests designated for expedited development and 

17 priority review, including any training required 

18 for such personnel to ensure effective and effi19 cient review. 

20 ‘‘(2) PROCESS.—Prior to finalizing the guid21 ance under paragraph (1), the Secretary shall seek 

22 public comment on the draft guidance. The Sec23 retary shall issue final guidance one year after the 

24 close of the comment period for the draft guidance. 


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1 ‘‘(g) ANNUAL REPORT.—Unless otherwise specified 

2 by the Secretary, the requirements under section 587B(k) 

3 apply to in vitro clinical tests designated under this sec4 tion. 

5 ‘‘(h) SERVICE OF ORDERS.—Orders of the Secretary 

6 under this section shall be served— 

7 ‘‘(1) in person by any officer or employee of the 

8 Department of Health and Human Services des9 ignated by the Secretary; or 

10 ‘‘(2) by mailing the order by registered mail or 

11 certified mail or electronic equivalent addressed to 

12 the applicant at his last known address in the 

13 records of the Secretary. 

14 ‘‘SEC. 587D. TECHNOLOGY CERTIFICATION. 

15 ‘‘(a) IN GENERAL.— 

16 ‘‘(1) ELIGIBILITY.—Any eligible person may 

17 seek a technology certification order in accordance 

18 with this section. 

19 ‘‘(2) EXCEPTION.—An in vitro clinical test is 

20 exempt from premarket review under section 587B 

21 and may be introduced into interstate commerce if 

22 the developer is eligible under this section and the 

23 in vitro clinical test— 

24 ‘‘(A) is an eligible in vitro clinical test 

25 under subsection (b)(2); and 


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1 ‘‘(B) falls within the scope of a technology 

2 certification order issued under this section that 

3 is in effect. 

4 ‘‘(b) ELIGIBILITY.— 

5 ‘‘(1) ELIGIBLE PERSON.—In this section, the 

6 term ‘eligible person’ means an in vitro clinical test 

7 developer unless, at the time such person seeks or 

8 would seek technology certification order, the per9 son— 

10 ‘‘(A) has been found to have committed a 

11 significant violation of section 353 of the Public 

12 Health Service Act, unless— 

13 ‘‘(i) such violation occurred more than 

14 5 years prior to the date on which such 

15 technology certification order is or would 

16 be sought; or 

17 ‘‘(ii) such violation has been resolved; 

18 ‘‘(B) fails to maintain required certifi19 cations under section 353 of the Public Health 

20 Service Act, as applicable; or 

21 ‘‘(C) has been found to have submitted in22 formation to the Secretary that— 

23 ‘‘(i) makes false or misleading state24 ments about a technology certification 


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1 order previously issued or an application 

2 approved under section 587B; or 

3 ‘‘(ii) violates any requirement of this 

4 subchapter, where such violation exposes 

5 individuals to serious risk of illness, injury, 

6 or death. 

7 ‘‘(2) TECHNOLOGY CERTIFICATION ELIGIBILITY

8 LIMITATIONS.—An in vitro clinical test is not eligible 

9 under subsection (a)(2) for exemption from pre10 market review under section 587B, if— 

11 ‘‘(A) such test is— 

12 ‘‘(i) a component or part of an in 

13 vitro clinical test as described in section 

14 201(ss)(1)(B)(v); 

15 ‘‘(ii) an instrument under section 

16 201(ss)(1)(B)(ii); 

17 ‘‘(iii) a specimen receptacle under sec18 tion 201(ss)(1)(B)(iii); 

19 ‘‘(iv) an in vitro clinical test, including 

20 reagents used in such tests, intended for 

21 use for testing donors, donations, and re22 cipients of blood, blood components, 

23 human cells, tissues, cellular-based prod24 ucts, or tissue-based products; or 


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1 ‘‘(v) a high-risk in vitro clinical test 

2 without mitigating measures under section 

3 587E, which may include first-of-a-kind in 

4 vitro clinical tests, home use in vitro clin5 ical tests, cross-referenced in vitro clinical 

6 tests, and direct-to-consumer in vitro clin7 ical tests. 

8 ‘‘(c) PUBLIC MEETING AND INPUT.— 

9 ‘‘(1) PUBLIC DOCKET.—Not later than 30 days 

10 after the date of enactment of the Verifying Accu11 rate Leading-edge IVCT Development Act of 2021, 

12 the Secretary shall establish a public docket to re13 ceive comments concerning recommendations for im14 plementation of this section, including criteria and 

15 procedures for subsections (e) through (j). The pub16 lic docket shall remain open for the duration of time 

17 that this section remains in effect. 

18 ‘‘(2) PUBLIC MEETING.—Not later than 180 

19 days after the date of enactment of the Verifying 

20 Accurate Leading-edge IVCT Development Act of 

21 2021, the Secretary shall convene a public meeting 

22 to which stakeholders from organizations rep23 resenting patients and consumers, academia, and the 

24 in vitro clinical test industry are invited in order to 

25 discuss the technology certification process including 


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1 application requirements, inspections, alignment 

2 with third-party accreditors, and the definition of 

3 ‘technology’ under section 587(17). 

4 ‘‘(d) REGULATIONS.—The Secretary shall issue regu5 lations on technology certification including describing cri6 teria or procedures relating to technology certification 

7 under this section, which shall be subject to public com8 ment for a minimum of 60 days from issuance prior to 

9 finalizing such regulations after considering the comments 

10 received. The regulation shall include an outline of the ap11 plication and recertification process, opportunities to meet 

12 with officials of the Food and Drug Administration and 

13 plans to streamline inspections. 

14 ‘‘(e) APPLICATION FOR TECHNOLOGY CERTIFI15 CATION.— 

16 ‘‘(1) IN GENERAL.—A person seeking a tech17 nology certification order shall submit an application 

18 under this subsection, which shall contain the infor19 mation specified under paragraph (2). 

20 ‘‘(2) CONTENT OF APPLICATION.—An applica21 tion for technology certification shall contain— 

22 ‘‘(A) a statement identifying the scope of 

23 the proposed technology certification, which 

24 shall be no broader than a single technology in25 tended to be offered under the application; 


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1 ‘‘(B) information describing that the per2 son seeking a technology certification order is 

3 an eligible person under subsection (b)(1); 

4 ‘‘(C) information describing that the meth5 ods used in, and the facilities and controls used 

6 for, the development of eligible in vitro clinical 

7 tests covered by the scope of the technology cer8 tification conform to the applicable quality re9 quirements of section 587J; 

10 ‘‘(D) procedures for analytical validation, 

11 including all procedures for validation, 

12 verification, and acceptance criteria, and an ex13 planation as to how such procedures, when 

14 used, provide a reasonable assurance of analyt15 ical validity of eligible in vitro clinical tests 

16 within the proposed scope of the technology cer17 tification order; 

18 ‘‘(E) procedures for clinical validation, in19 cluding all procedures for validation, 

20 verification, and acceptance criteria, and an ex21 planation as to how such procedures, when 

22 used, provide a reasonable assurance of clinical 

23 validity of eligible in vitro clinical tests within 

24 the proposed scope of the technology certifi25 cation order; 


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1 ‘‘(F) a submission under section 587I(b) 

2 for each in vitro clinical test that the developer 

3 intends to introduce into interstate commerce 

4 upon receiving a technology certification order; 

5 ‘‘(G) 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 filing of the application 

11 under this section to serve as the rep12 resentative test and validate and run with13 in the developer’s stated scope; 

14 ‘‘(ii) the information specified in sub15 section (c) or (d) of section 587B, as appli16 cable, for the representative in vitro clin17 ical test or tests, including information and 

18 data required pursuant to subsection 

19 (c)(2)(H) of section 587B, unless the Sec20 retary determines that such information is 

21 not necessary; 

22 ‘‘(iii) an explanation of the choice of 

23 the representative in vitro clinical test or 

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1 onstrates the range of procedures that the 

2 developer includes in the application under 

3 subparagraphs (C), (D), (E), and (F); and 

4 ‘‘(iv) a brief explanation of the ways 

5 in which the procedures included in the ap6 plication under subparagraphs (C), (D), 

7 (E), and (F) have been applied to the rep8 resentative in vitro clinical test or tests; 

9 ‘‘(H) such other information as the Sec10 retary may determine necessary; and 

11 ‘‘(I) a statement that the applicant believes 

12 to the best of the applicant’s knowledge that all 

13 data and information submitted to the Sec14 retary are truthful and accurate and that no 

15 material fact has been omitted. 

16 ‘‘(3) REFERENCE TO APPROVED PREMARKET

17 APPLICATION UNDER SECTION 587B.—With respect 

18 to the content requirements in the technology certifi19 cation application described in paragraph (2), a de20 veloper may incorporate by reference any content of 

21 an application previously submitted by the developer 

22 and approved under section 587B. 

23 ‘‘(f) ACTION ON AN APPLICATION FOR TECHNOLOGY

24 CERTIFICATION.— 

25 ‘‘(1) SECRETARY RESPONSE.— 


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1 ‘‘(A) IN GENERAL.—As promptly as prac2 ticable, and no later than 90 days after receipt 

3 of an application under subsection (c), the Sec4 retary shall— 

5 ‘‘(i) issue a technology certification 

6 order granting the application, which shall 

7 specify the scope of the technology certifi8 cation, if the Secretary finds that all of the 

9 grounds in paragraph (3) are met; or 

10 ‘‘(ii) deny the application if the Sec11 retary finds (and sets forth the basis of 

12 such finding as part of or accompanying 

13 such denial) that one or more grounds for 

14 granting the application specified in para15 graph (3) are not met. 

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

17 in subparagraph (A) may be extended by mu18 tual agreement between the Secretary and the 

19 applicant. 

20 ‘‘(2) DEFICIENT APPLICATIONS.— 

21 ‘‘(A) If, after receipt of an application 

22 under this section, the Secretary determines 

23 that any portion of such application is deficient, 

24 the Secretary, not later than 60 days after re25 ceipt of such application, shall provide to the 


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1 applicant a description of such deficiencies and 

2 identify the information required to correct 

3 such deficiencies. 

4 ‘‘(B) When responding to the deficiency 

5 letter, the applicant 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 grant a technology certification 

11 order under this section if, on the basis of the infor12 mation submitted to the Secretary as part of the ap13 plication and any other information with respect to 

14 such applicant, the Secretary finds that— 

15 ‘‘(A) in accordance with subsection 

16 (e)(2)(D), there is a showing of reasonable as17 surance of analytical validity for all eligible in 

18 vitro clinical tests within the proposed scope of 

19 the technology certification, as evidenced by the 

20 procedures for analytical validation; 

21 ‘‘(B) in accordance with subsection 

22 (e)(2)(E), there is a showing of reasonable as23 surance of clinical validity for eligible in vitro 

24 clinical tests within the proposed scope of the 

25 technology certification, as evidenced by the 


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1 clinical program, including procedures for clin2 ical validation; 

3 ‘‘(C) the methods used in, or the facilities 

4 or controls used for, the development of eligible 

5 in vitro clinical tests covered by the proposed 

6 scope of the technology certification conform to 

7 the applicable requirements of section 587J; 

8 ‘‘(D) based on a fair evaluation of all ma9 terial facts, the applicant’s proposed labeling 

10 and advertising is not false or misleading in any 

11 particular; 

12 ‘‘(E) the application does not contain a 

13 false statement of material fact; 

14 ‘‘(F) there is a showing that the represent15 ative in vitro clinical test or tests— 

16 ‘‘(i) meet the applicable standard for 

17 such order; and 

18 ‘‘(ii) reasonably represent the range of 

19 procedures for analytical validation and 

20 clinical validation included in the applica21 tion, as applicable; and 

22 ‘‘(G) the applicant permits authorized em23 ployees of the Food and Drug Administration 

24 or persons accredited under this Act an oppor25 tunity to inspect at a reasonable time and in a 


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1 reasonable manner the facilities and all perti2 nent equipment, finished and unfinished mate3 rials, containers, and labeling therein, including 

4 all things (including records, files, papers, and 

5 controls) bearing on whether an in vitro clinical 

6 test is adulterated, misbranded, or otherwise in 

7 violation of this Act, and permits such author8 ized employees or persons accredited under this 

9 Act to view and to copy and verify all records 

10 pertinent to the application and the in vitro 

11 clinical test. 

12 ‘‘(4) EFFECT OF TECHNOLOGY CERTIFICATION

13 ORDER.—An in vitro clinical test or tests within the 

14 scope of a granted technology certification order are 

15 cleared to be introduced into interstate commerce. 

16 ‘‘(5) REVIEW OF DENIALS.—If the Secretary 

17 denies an application for technology certification, in18 cluding an application for renewal under subsection 

19 (g), the Secretary will provide a summary of defi20 ciencies on which the Secretary based its denial. An 

21 applicant whose application has been denied may, by 

22 petition filed on or before the date that is 30 cal23 endar days after the date upon which such applicant 

24 receives notice of such denial, obtain review thereof 

25 in accordance with section 587O. 


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1 ‘‘(g) DURATION; SUBSEQUENT SUBMISSIONS.— 

2 ‘‘(1) ORDER DURATION.—A technology certifi3 cation order shall remain in effect until the earlier 

4 of— 

5 ‘‘(A) the expiration of such technology cer6 tification order under paragraph (2); or 

7 ‘‘(B) the withdrawal of such technology 

8 certification order under subsection (j). 

9 ‘‘(2) EXPIRATION.— 

10 ‘‘(A) An initial technology certification 

11 order issued under subsection (f)(3) shall expire 

12 4 years after the date that such order is issued, 

13 except that if an application for renewal under 

14 paragraph (3) has been received not later than 

15 30 days prior to the expiration of such order 

16 under this paragraph, such order shall expire 

17 on the date on which the Secretary has granted 

18 or denied the application for renewal. Any such 

19 subsequent renewal of a technology certification 

20 shall expire on such date specified by the Sec21 retary that is not later than 4 years after the 

22 date that such technology certification order is 

23 issued. 

24 ‘‘(B) In the event of expiration of tech25 nology certification order, the clearance of tests 


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1 introduced into interstate commerce under such 

2 order prior to its expiration pursuant to sub3 section (f)(3) remain in effect. 

4 ‘‘(3) RENEWAL.— 

5 ‘‘(A) IN GENERAL.—Any person previously 

6 granted a technology certification order in ef7 fect may seek renewal of such order provided 

8 that— 

9 ‘‘(i) such person is an eligible person 

10 under subsection (b)(1); 

11 ‘‘(ii) the previously granted technology 

12 certification order— 

13 ‘‘(I) is not on temporary hold 

14 under subsection (i); and 

15 ‘‘(II) was not withdrawn under 

16 subsection (j); and 

17 ‘‘(iii) none of the information specified 

18 in subsection (e)(2) has substantially 

19 changed, except as described in supple20 ments to orders granted under paragraph 

21 (4). 

22 ‘‘(B) CONTENT.—An application for re23 newal under this paragraph shall include infor24 mation concerning one or more representative 

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1 section (e)(2)(G), except that such representa2 tive test or tests shall be different from the rep3 resentative test or tests relied upon as the rep4 resentative assay in any prior technology certifi5 cation, if applicable. 

6 ‘‘(C) PROCESS.—The Secretary’s action on 

7 an application for renewal of technology certifi8 cation under this paragraph shall be conducted, 

9 to the extent practicable, in coordination with 

10 inspections conducted under section 353 of the 

11 Public Health Service Act, if applicable, and 

12 any order resulting from such renewal applica13 tion shall be treated as a technology certifi14 cation order for purposes of this subchapter. 

15 ‘‘(4) SUPPLEMENTS AND REPORTS.— 

16 ‘‘(A) SUPPLEMENTS.—Except as provided 

17 in subparagraph (B), any person with a tech18 nology certification order in effect may seek a 

19 supplement to such order upon a change or 

20 changes to the information provided in the ap21 plication for technology certification under sub22 paragraphs (C), (D), and (E) of subsection 

23 (e)(2), provided that— 

24 ‘‘(i) such person is an eligible person 

25 under subsection (b)(1); and 


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1 ‘‘(ii) such change does not expand the 

2 scope of the technology certification, unless 

3 the Secretary determines that such expan4 sion is appropriate. 

5 A supplement to an order may contain only in6 formation relevant to the change or changes. 

7 The Secretary’s action on a supplement shall be 

8 in accordance with subsection (f), and any 

9 order resulting from such supplement shall be 

10 treated as an amendment to a technology cer11 tification order that is in effect. 

12 ‘‘(B) REPORTS.— 

13 ‘‘(i) IN GENERAL.—If a change is 

14 made to an in vitro clinical test or tests 

15 that is beyond the scope of a technology 

16 certification order but is made in order to 

17 address a potential risk to public health by 

18 adding a new specification or test method, 

19 the person may immediately implement 

20 such change or changes and shall report 

21 such changes or changes to the Secretary 

22 within 30 days. 

23 ‘‘(ii) CONTENT.—Any report to the 

24 Secretary under this subparagraph shall 

25 include— 


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1 ‘‘(I) a summary of the relevant 

2 change or changes; 

3 ‘‘(II) the rationale for imple4 menting such change or changes; 

5 ‘‘(III) a description of how the 

6 change or changes were evaluated; 

7 and 

8 ‘‘(IV) data indicating analytical 

9 and clinical validity. 

10 ‘‘(iii) SUPPLEMENTAL REPORTS.— 

11 Upon review of such report and a finding 

12 that the relevant change or changes are in13 consistent with the standard specified 

14 under this subparagraph, the Secretary 

15 may require a supplement under subpara16 graph (A). 

17 ‘‘(h) MAINTENANCE REQUIREMENTS.—For the dura18 tion of a technology certification order, a holder of a tech19 nology certification order shall— 

20 ‘‘(1) use the procedures included in the relevant 

21 application, supplement, or report under subsections 

22 (b) and (e); 

23 ‘‘(2) ensure compliance with any applicable 

24 mitigating measures; 


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1 ‘‘(3) maintain, and provide to the Secretary 

2 upon request, records related to any in vitro clinical 

3 test offered under the technology certification order, 

4 where those records are necessary to demonstrate 

5 compliance with applicable provisions of this sub6 chapter; and 

7 ‘‘(4) comply with the listing requirements under 

8 section 587I for each in vitro clinical test offered 

9 under the technology certification order. 

10 ‘‘(i) TEMPORARY HOLD.— 

11 ‘‘(1) IN GENERAL.—Upon one or more findings 

12 under paragraph (4) and after promptly notifying 

13 the developer of such findings, the Secretary may 

14 issue a temporary hold prohibiting any holder of a 

15 technology certification order from introducing into 

16 interstate commerce an in vitro clinical test that was 

17 not previously the subject of a notification under 

18 section 587I. The temporary hold must identify the 

19 grounds for the temporary hold under paragraph (4) 

20 and the rationale for such finding, and may only re21 main in place until the Secretary responds to a writ22 ten request under paragraph (3). 

23 ‘‘(2) NOTIFICATION TO THE DEVELOPER.—The 

24 Secretary shall not place a temporary hold under 

25 this subsection unless the Secretary has promptly 


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1 notified the developer of such hold and provided 30 

2 calendar days for the developer to come into compli3 ance with or resolve the findings under paragraph 

4 (4). 

5 ‘‘(3) WRITTEN REQUESTS.—Any written re6 quest to the Secretary from the holder of a tech7 nology certification order that a temporary hold 

8 under paragraph (1) be removed shall receive a deci9 sion, in writing and specifying the reasons therefore, 

10 within 90 days after receipt of such request. Any 

11 such request shall include information to support the 

12 removal of the temporary hold. 

13 ‘‘(4) GROUNDS FOR TEMPORARY HOLD.—A 

14 temporary hold under this subsection may be 

15 instated upon a finding or findings that the holder 

16 of a technology certification order— 

17 ‘‘(A) is not in compliance with any mainte18 nance requirements under subsection (h); 

19 ‘‘(B) labels or advertises one or more in 

20 vitro clinical tests with false or misleading 

21 claims; or 

22 ‘‘(C) is no longer an eligible person under 

23 subsection (b)(1). 

24 ‘‘(j) WITHDRAWAL.—The Secretary may, after due 

25 notice and opportunity for informal hearing, issue an 


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1 order withdrawing a technology certification order if the 

2 Secretary finds that— 

3 ‘‘(1) the application, supplement, or report 

4 under subsection (e) or (g) contains materially false 

5 or misleading information or fails to reveal a mate6 rial fact; 

7 ‘‘(2) such holder fails to correct materially false 

8 or misleading labeling or advertising upon the re9 quest of the Secretary; 

10 ‘‘(3) in connection with a technology certifi11 cation, the holder provides materially false or mis12 leading information to the Secretary; or 

13 ‘‘(4) the holder of such technology certification 

14 order fails to correct the grounds for temporary hold 

15 within a timeframe specified in the temporary hold 

16 order. 

17 ‘‘(k) REPORTS TO CONGRESS.— 

18 ‘‘(1) IN GENERAL.—Not later than one year 

19 after date of enactment of the Verifying Accurate 

20 Leading-edge IVCT Development Act of 2021, and 

21 annually thereafter for the next 4 years, the Sec22 retary shall submit to the Committee on Energy and 

23 Commerce of the House of Representatives and the 

24 Committee on Health, Education, Labor, and Pen25 sions of the Senate, and make publicly available, inVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00101 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 cluding through posting on the website of the Food 

2 and Drug Administration, a report containing the 

3 information described in paragraph (2). 

4 ‘‘(2) CONTENT.— 

5 ‘‘(A) IN GENERAL.—Each report under 

6 paragraph (1) shall address, at a minimum— 

7 ‘‘(i) the total number of applications 

8 for technology certifications filed, granted, 

9 withdrawn and denied; 

10 ‘‘(ii) the total number of technology 

11 certification orders put on temporary hold 

12 under subsection (i) and the number of 

13 technology certification orders withdrawn 

14 under subsection (j); 

15 ‘‘(iii) the types of technologies for 

16 which technology certification orders were 

17 granted; 

18 ‘‘(iv) the total number of developers, 

19 including laboratories, with technology cer20 tification orders in effect; and 

21 ‘‘(v) the total number of approved 

22 tests under section 587B that were reclas23 sified and granted a technology certifi24 cation order under this section. 


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1 ‘‘(B) FINAL REPORT.—The fifth report 

2 submitted under paragraph (1) shall include a 

3 summary of, and responses to, comments raised 

4 in the meeting and docket. 

5 ‘‘(C) PERFORMANCE REPORTS.—The re6 ports required under this section may be issued 

7 with performance reports as required under sec8 tion 9 of the Verifying Accurate Leading-edge 

9 IVCT Development Act of 2021. 

10 ‘‘SEC. 587E. MITIGATING MEASURES. 

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

12 ‘‘(1) ESTABLISHING, CHANGING, OR WITH13 DRAWING.— 

14 ‘‘(A) ESTABLISHMENT.—If the Secretary 

15 requires the establishment of mitigating meas16 ures pursuant to clause (i) or (ii) of section 

17 587(15)(A) for any in vitro clinical test, the 

18 Secretary may require such mitigating meas19 ures for any other in vitro clinical test with the 

20 same indications for use. 

21 ‘‘(B) PROCESS.—Notwithstanding sub22 chapter II of chapter 5 of title 5, United States 

23 Code, the Secretary may— 

24 ‘‘(i) establish, change, or withdraw 

25 mitigating measures by— 


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1 ‘‘(I) publishing a proposed ad2 ministrative order in the Federal Reg3 ister; 

4 ‘‘(II) providing an opportunity 

5 for public comment for a period of not 

6 less than 30 calendar days; and 

7 ‘‘(III) after consideration of any 

8 comments submitted, publishing a 

9 final administrative order in the Fed10 eral Register; and 

11 ‘‘(ii) may establish mitigating meas12 ures with respect to a category in a pre13 market approval order or technology cer14 tification order. 

15 ‘‘(2) IN VITRO CLINICAL TESTS PREVIOUSLY

16 APPROVED, CLEARED, OR EXEMPTED AS DEVICES.— 

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

18 or restrictions applicable to an in vitro clinical 

19 test with the same indications for use pursuant 

20 to section 587(10) based on prior regulation as 

21 a device approved under section 515, cleared or 

22 exempt under section 510(k), or classified 

23 under section 513(f)(2), including any such spe24 cial controls or restrictions established during 

25 the period beginning on the date of enactment 


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1 of the Verifying Accurate Leading-edge IVCT 

2 Development Act of 2021 and ending on the ef3 fective date of such Act (as described in section 

4 5(b) of such Act)— 

5 ‘‘(i) shall continue to apply to such 

6 approved, cleared, or exempted in vitro 

7 clinical test after such effective date; and 

8 ‘‘(ii) are deemed to be mitigating 

9 measures as of the effective date of such 

10 approval, clearance, or exemption. 

11 ‘‘(B) CHANGES.—The Secretary may es12 tablish, change, or withdraw mitigating meas13 ures for such a test or indications for use the 

14 procedures under paragraph (1). 

15 ‘‘(b) DOCUMENTATION.— 

16 ‘‘(1) TESTS SUBJECT TO PREMARKET RE17 VIEW.—The developer of an in vitro clinical test sub18 ject to premarket review under section 587B and to 

19 which mitigating measures apply shall— 

20 ‘‘(A) in accordance with section 

21 587B(c)(2)(G)(i), submit documentation to the 

22 Secretary as part of the application for the test 

23 under subsection (c) or (d) of section 587B 

24 demonstrating that such mitigating measures 

25 have been met; 


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1 ‘‘(B) if such application is approved, main2 tain documentation demonstrating that such 

3 mitigating measures continue to be met fol4 lowing a test modification by the developer; and 

5 ‘‘(C) after responding to any informal com6 munications from the Secretary, make such 

7 documentation available to the Secretary upon 

8 request or inspection. 

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

10 vitro clinical test that is marketed within the scope 

11 of a technology certification order or other exemp12 tion from premarket review under section 587B and 

13 to which mitigating measures apply shall— 

14 ‘‘(A) maintain documentation in accord15 ance with the applicable quality requirements 

16 under section 587J demonstrating that such 

17 mitigating measures continue to be met fol18 lowing a test modification by the developer; 

19 ‘‘(B) after responding to any informal 

20 communications from the Secretary, make such 

21 documentation available to the Secretary upon 

22 request or inspection; and 

23 ‘‘(C) include in the performance summary 

24 for such test a brief description of how such 

25 mitigating measures are met, if applicable. 


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1 ‘‘(c) MITIGATING MEASURES FOR CROSS-REF2 ERENCED TESTS.—Not later than 1 year after the imple3 mentation of the Verifying Accurate Leading-edge IVCT 

4 Development Act of 2021, the Secretary shall issue miti5 gating measures for cross-referenced tests. 

6 ‘‘SEC. 587F. REGULATORY PATHWAY REDESIGNATION. 

7 ‘‘(a) TECHNOLOGY CERTIFICATION AND EXEMPTION

8 DETERMINATIONS.— 

9 ‘‘(1) IN GENERAL.—Based on new information, 

10 including the establishment of mitigating measures 

11 under section 587E, and after considering available 

12 evidence respecting tests with the same indications 

13 for use pursuant to section 587(10), the Secretary 

14 may, upon the initiative of the Secretary or upon pe15 tition of an interested person— 

16 ‘‘(A) revoke any exemption or requirement 

17 in effect under this subchapter with respect to 

18 such indications for use; or 

19 ‘‘(B) determine that such indications for 

20 use are eligible for technology certification in 

21 accordance with section 587D(b)(2). 

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

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

24 proposed action on the website of the Food and 

25 Drug Administration, the consideration of comments 


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1 to a public docket on such proposal, and publication 

2 of a final action on such website within 60 calendar 

3 days of the close of the comment period posted to 

4 such public docket, notwithstanding subchapter II of 

5 chapter 5 of title 5, United States Code. 

6 ‘‘(b) REVOCATION.—The Secretary may revoke any 

7 exemption with respect to such test or indications for use 

8 pursuant to section 587(10), if— 

9 ‘‘(1) new clinical information indicates that the 

10 exemption of an in vitro clinical test or tests from 

11 premarket review under section 587B or exemption 

12 under section 587A has a reasonable probability of 

13 severe adverse health consequences, including the 

14 absence, delay, or discontinuation of appropriate 

15 medical treatment. 

16 ‘‘(2) PROCESS.—Any action under this sub17 section shall be made by publication of a notice of 

18 such proposed action in the Federal Register, con19 sideration of comments to a public docket on such 

20 proposal, and publication of a final notice in the 

21 Federal Register, notwithstanding subchapter II of 

22 chapter 5 of title 5, United States Code. 

23 ‘‘SEC. 587G. ADVISORY COMMITTEES. 

24 ‘‘(a) IN GENERAL.—The Secretary may establish ad25 visory committees or use advisory committee panels of exVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00108 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 perts established before the date of enactment of this sec2 tion for the purposes of providing expert scientific advice 

3 and making recommendations related to— 

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

5 vitro clinical test submitted under this subchapter, 

6 including for evaluating, as applicable, the analytical 

7 validity, clinical validity, and safety of in vitro clin8 ical tests; 

9 ‘‘(2) the potential effectiveness of mitigating 

10 measures for a determination on the applicable regu11 latory pathway under section 587F or risk evalua12 tion for an in vitro clinical test or tests; 

13 ‘‘(3) quality requirements under section 587J 

14 or applying such requirements to in vitro clinical 

15 tests developed or imported by developers; or 

16 ‘‘(4) such other purposes as the Secretary de17 termines appropriate. 

18 ‘‘(b) APPOINTMENTS.— 

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

20 appoint to each committee established under sub21 section (a), as voting members, individuals who are 

22 qualified by training and experience to evaluate in 

23 vitro clinical tests referred to the committee for the 

24 purposes specified in subsection (a), including indi25 viduals with, to the extent feasible, scientific experVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00109 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 tise in the development, manufacture, or utilization 

2 of such in vitro clinical tests, laboratory operations, 

3 and the use of in vitro clinical tests. The Secretary 

4 shall designate one member of each committee to 

5 serve as chair. 

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

7 individuals appointed pursuant to paragraph (1), the 

8 Secretary shall appoint to each committee estab9 lished under subsection (a), as nonvoting members— 

10 ‘‘(A) a representative of consumer inter11 ests; and 

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

13 vitro clinical test developers not directly af14 fected by the matter to be brought before the 

15 committee. 

16 ‘‘(3) LIMITATION.—No individual who is in the 

17 regular full-time employee of the United States and 

18 engaged in the administration of this Act may be a 

19 member of any advisory committee established under 

20 subsection (a). 

21 ‘‘(4) EDUCATION AND TRAINING.—The Sec22 retary shall, as appropriate, provide education and 

23 training to each new committee member before such 

24 member participates in a committee’s activities, in25 cluding education regarding requirements under this 


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1 Act and related regulations of the Secretary, and the 

2 administrative processes and procedures related to 

3 committee meetings. 

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

5 that scientific advisory committees meet regularly 

6 and at appropriate intervals so that any matter to 

7 be reviewed by such a committee can be presented 

8 to the committee not more than 60 calendar days 

9 after the matter is ready for such review. Meetings 

10 of the committee may be held using electronic com11 munication to convene the meetings. 

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

13 committee established under subsection (a), while at14 tending meetings or conferences or otherwise en15 gaged in the business of the advisory committee— 

16 ‘‘(A) shall be entitled to receive compensa17 tion at rates to be fixed by the Secretary, but 

18 not to exceed the daily equivalent of the rate in 

19 effect for positions classified above level GS–15 

20 of the General Schedule; and 

21 ‘‘(B) may be allowed travel expenses as au22 thorized by section 5703 of title 5, United 

23 States Code, for employees serving intermit24 tently in the Government service. 


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

2 on the policies and procedures governing advisory commit3 tees established under subsection (a). 

4 ‘‘SEC. 587H. REQUEST FOR INFORMAL FEEDBACK. 

5 ‘‘Before submitting a premarket application or tech6 nology certification application for an in vitro clinical 

7 test— 

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

9 Secretary a written request for a meeting, con10 ference, or written feedback to discuss and provide 

11 information relating to the regulation of such in 

12 vitro clinical test which may include— 

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

14 and amount of evidence expected to dem15 onstrate the applicable standard; 

16 ‘‘(B) which regulatory pathway is appro17 priate for an in vitro clinical test; and 

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

19 clinical test, including a clinical protocol; and 

20 ‘‘(2) upon receipt of such a request, the Sec21 retary shall— 

22 ‘‘(A) within 60 calendar days after such 

23 receipt, or within such time period as may be 

24 agreed to by the developer, meet or confer with 

25 the developer submitting the request; and 


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1 ‘‘(B) within 15 calendar days after such 

2 meeting or conference, provide to the developer 

3 a written record or response describing the 

4 issues discussed and conclusions reached in the 

5 meeting or conference. 

6 ‘‘SEC. 587I. REGISTRATION AND LISTING. 

7 ‘‘(a) REGISTRATION OF ESTABLISHMENTS FOR IN

8 VITRO CLINICAL TESTS.— 

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

10 subsection (b)(1), or an accredited person under sec11 tion 587P, acting on behalf of such a person, shall— 

12 ‘‘(A) during the period beginning on Octo13 ber 1 and ending on December 31 of each year, 

14 register with the Secretary the name of such 

15 person, places of business of such person, all es16 tablishments engaged in the activities specified 

17 under this paragraph, the establishment reg18 istration number of each such establishment, 

19 and a point of contact for each such establish20 ment, including an electronic point of contact; 

21 and 

22 ‘‘(B) submit an initial registration con23 taining the information required under subpara24 graph (A) not later than— 


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1 ‘‘(i) the date of implementation of this 

2 section if such establishment is engaged in 

3 any activity described in subsection (b)(1) 

4 on the date of enactment of this section, 

5 unless the Secretary establishes by guid6 ance a date later than such implementation 

7 date for all or a category of such establish8 ments; or 

9 ‘‘(ii) 30 days prior to engaging in any 

10 activity described in subsection (b)(1) after 

11 enactment of this section, if such establish12 ment is not engaged in any activity de13 scribed in this paragraph on the date of 

14 enactment of this section. 

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

16 may assign a registration number to any person or 

17 an establishment registration number to any estab18 lishment registered in accordance with this section. 

19 Registration information shall be made publicly 

20 available by publication on the website maintained 

21 by the Food and Drug Administration, in accord22 ance with subsection (d). 

23 ‘‘(3) INSPECTION.—Each person or establish24 ment that is required to be registered with the SecVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00114 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 retary under this section shall be subject to inspec2 tion pursuant to section 704. 

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

4 TESTS.— 

5 ‘‘(1) IN GENERAL.—Each person who— 

6 ‘‘(A) is a developer, a contract manufac7 turer (including contract packaging), contract 

8 sterilizer, repackager, relabeler, or distributor of 

9 an in vitro clinical test; and 

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

11 introduction or delivery for introduction into 

12 interstate commerce through an exemption 

13 under section 587A(f)(2)(b) or 587A(g) or 

14 through the filing of an application under sec15 tion 587B or 587D, 

16 shall submit a listing to the Secretary containing the 

17 information described in paragraph (2) in accord18 ance with the applicable schedule described under 

19 subsection (c). Such listing shall be prepared in such 

20 form and manner as the Secretary may specify in 

21 guidance. Listing information shall be submitted 

22 through the comprehensive test information system 

23 in accordance with section 587T, as appropriate. 

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

25 a listing under paragraph (1) shall electronically 


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1 submit to the comprehensive test information system 

2 under section 587T the following information for 

3 each in vitro clinical test for which such person is 

4 a developer in the form and manner prescribed by 

5 the Secretary: 

6 ‘‘(A) Name of the establishment and its es7 tablishment registration number. 

8 ‘‘(B) Contact information for the official 

9 correspondent for the listing. 

10 ‘‘(C) Name (common name and trade 

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

12 and its test listing number (when available). 

13 ‘‘(D) CLIA certificate number for any lab14 oratory certified by the Secretary under section 

15 353 of the Public Health Service Act that 

16 meets the requirements for performing high17 complexity testing that is the developer of the 

18 in vitro clinical test, and CLIA certificate num19 ber for any laboratory under common ownership 

20 that is performing the test developed by such 

21 test developer. 

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

23 as applicable, offered as a test approved under 

24 section 587B, offered under a technology cer25 tification o, or offered as an in vitro clinical test 


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1 under section 587Arder issued under section 

2 587D. 

3 ‘‘(F) Indications for use information under 

4 section 587(10). 

5 ‘‘(G) Brief narrative description of the in 

6 vitro clinical test. 

7 ‘‘(H) A brief summary of the analytical 

8 and clinical performance of the in vitro clinical 

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

10 ‘‘(I) A brief description of conformance 

11 with any applicable mitigating measures, re12 strictions, and standards. 

13 ‘‘(J) Representative labeling for the in 

14 vitro clinical test, as appropriate. 

15 ‘‘(K) A statement that the information 

16 submitted is truthful and accurate. 

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

18 may assign a test listing number to each in vitro 

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

20 section. The process for assigning test listing num21 bers may be established through guidance, and may 

22 include the recognition of standards, formats, or 

23 conventions developed by a third-party organization. 

24 ‘‘(4) ABBREVIATED LISTING.—A person who is 

25 not a developer but is otherwise required to register 


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1 pursuant to subsection (a) shall submit an abbre2 viated listing to the Secretary containing the infor3 mation described in subparagraphs (A) through (C) 

4 of paragraph (2), and the name of the developer. 

5 The information shall be submitted in accordance 

6 with the applicable schedule described under sub7 section (c). Such abbreviated listing shall be pre8 pared in such form and manner as the Secretary 

9 may specify in guidance. Listing information shall be 

10 submitted to the comprehensive test information sys11 tem in accordance with section 587T, as appro12 priate. 

13 ‘‘(5) GRANDFATHERED TESTS.—A developer of 

14 an in vitro clinical test developer offering a test that 

15 is grandfathered under section 587A(c) shall submit 

16 listing information required under subparagraphs 

17 (A) through (K) of paragraph (2). 

18 ‘‘(6) LOW-RISK TESTS.—A developer of a low 

19 risk in vitro clinical test shall notify and submit list20 ing information to the Secretary within one year of 

21 offering such test for clinical use. 

22 ‘‘(7) EXEMPT TESTS.—A developer of an in 

23 vitro clinical test who introduces or proposes to 

24 begin the introduction or delivery for introduction 

25 into interstate commerce pursuant to an exemption 


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1 under section 587A may submit listing information 

2 under this subsection. 

3 ‘‘(c) TIMELINES FOR SUBMISSION.— 

4 ‘‘(1) IN GENERAL.—The timelines for submis5 sion of registration and listing under subsections (a) 

6 and (b) are as follows: 

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

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

9 the date of enactment of this section, a person 

10 shall maintain a device listing under section 

11 510 until such time as the system for submit12 ting the notification information required under 

13 subsection (b) becomes available and thereafter 

14 shall submit the notification information no 

15 later than 1 year after the system for submit16 ting the notification under this section becomes 

17 available. 

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

19 subject to the grandfathering provisions of sec20 tion 587A(c), a person shall submit the listing 

21 information required under subsection (b)(5) no 

22 later than 1 year after the system for submit23 ting the notification under this section becomes 

24 available. 


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

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

3 person shall submit the required notification in4 formation prior to offering, introducing, or mar5 keting the in vitro clinical test as follows: 

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

7 is not exempt from premarket approval 

8 under section 587B, a person shall submit 

9 the required listing information no later 

10 than 30 business days after the date of ap11 proval of the premarket approval applica12 tion. 

13 ‘‘(ii) For a developer who has received 

14 a technology certification order under sec15 tion 587D, a person shall submit the re16 quired listing information at least 30 busi17 ness days after receiving such technology 

18 certification order. 

19 ‘‘(2) UPDATES.— 

20 ‘‘(A) UPDATES AFTER CHANGES.—Each 

21 developer required to submit listing information 

22 under this section shall update such informa23 tion within 10 business days of any change that 

24 causes any previously notified information to be 

25 inaccurate or incomplete. 


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

2 required to submit listing information under 

3 this section shall update its information annu4 ally during the period beginning on October 1 

5 and ending on December 31 of each year as a 

6 component of the annual report submitted 

7 under sections 587B and 587D. 

8 ‘‘(d) PUBLIC AVAILABILITY OF NOTIFICATION IN9 FORMATION.— 

10 ‘‘(1) IN GENERAL.—Notification information 

11 submitted pursuant to this section shall be made 

12 publicly available on the website of the Food and 

13 Drug Administration in accordance with paragraph 

14 (3). 

15 ‘‘(2) CONFIDENTIALITY.—Notification informa16 tion for an in vitro clinical test that is subject to 

17 premarket approval or technical certification shall 

18 remain confidential until such date as the in vitro 

19 clinical test receives the applicable premarket ap20 proval or the developer receives a technology certifi21 cation order. 

22 ‘‘(3) EXCEPTIONS FROM PUBLIC AVAILABILITY

23 REQUIREMENTS.—The registration and listing infor24 mation requirements described in subsections (a) 


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1 and (b) shall not apply to the extent the Secretary 

2 determines that such information relates to— 

3 ‘‘(A) trade secret or commercial confiden4 tial information; or 

5 ‘‘(B) national security or countermeasures 

6 or is restricted from disclosure pursuant to an7 other provision of law. 

8 ‘‘(e) SUBMISSION OF INFORMATION BY ACCREDITED

9 PERSONS.—If agreed upon by the developer, the informa10 tion required under this section may be submitted by an 

11 accredited person under section 587P. 

12 ‘‘SEC. 587J. TEST DESIGN AND QUALITY REQUIREMENTS. 

13 ‘‘(a) APPLICABILITY.— 

14 ‘‘(1) IN GENERAL.—Each developer and each 

15 other person required to register under section 

16 587I(b)(1) shall establish and maintain quality re17 quirements in accordance with the applicable re18 quirements set forth in subsection (b), except as pro19 vided in section 587A. 

20 ‘‘(2) CERTIFIED LABORATORY REQUIRE21 MENTS.—A developer that operates a clinical labora22 tory certified by the Secretary under section 353 of 

23 the Public Health Service Act that— 

24 ‘‘(A) meets the requirements for per25 forming high-complexity testing; 


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1 ‘‘(B)(i) develops an vitro clinical test or in2 dications for use; or 

3 ‘‘(ii) modifies another developer’s in vitro 

4 clinical test in that certified laboratory in a 

5 manner described in section 587(6)(C); and 

6 ‘‘(C) develops an in vitro clinical test or in7 dications for use that are for use only within 

8 that certified laboratory or within another cer9 tified laboratory with common ownership, 

10 shall establish and maintain quality requirements 

11 that comply with the requirements set forth in sub12 section (b)(2). 

13 ‘‘(3) APPLICABILITY FOR CERTAIN IN VITRO

14 CLINICAL TESTS.—The applicable requirements set 

15 forth in subsection (b)(1) shall apply to any instru16 ment, specimen receptacle, or component or part 

17 that is developed for use by a clinical laboratory to 

18 which paragraph (2) applies. 

19 ‘‘(4) REGULATIONS.—In promulgating regula20 tions under this section, the Secretary shall consider 

21 whether and to what extent international harmoni22 zation is appropriate. 

23 ‘‘(b) QUALITY REQUIREMENTS.— 

24 ‘‘(1) QUALITY REQUIREMENTS FOR LABORA25 TORIES WITHOUT CLIA CERTIFICATION TO CONDUCT


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1 HIGH-COMPLEXITY TESTS.—The quality require2 ments applicable under this section shall— 

3 ‘‘(A) avoid duplication of regulations under 

4 section 353 of the Public Health Service Act; 

5 ‘‘(B) apply only to the development, valida6 tion, production, preparation, propagation, or 

7 assembly related to the design and associated 

8 manufacture and distribution of an in vitro clin9 ical test offered under this subchapter; 

10 ‘‘(C) not apply with respect to laboratory 

11 operations; and 

12 ‘‘(D) shall include the following, subject to 

13 paragraphs (2) and (3)— 

14 ‘‘(i) management responsibility; 

15 ‘‘(ii) quality audits; 

16 ‘‘(iii) personnel; 

17 ‘‘(iv) design controls; 

18 ‘‘(v) document controls; 

19 ‘‘(vi) purchasing controls; 

20 ‘‘(vii) identification and traceability; 

21 ‘‘(viii) production and process con22 trols; 

23 ‘‘(ix) acceptance activities; 

24 ‘‘(x) nonconforming product; 

25 ‘‘(xi) corrective and preventive action; 


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1 ‘‘(xii) labeling and packaging controls; 

2 ‘‘(xiii) handling, storage, distribution, 

3 and installation; 

4 ‘‘(xiv) records; 

5 ‘‘(xv) servicing; and 

6 ‘‘(xvi) statistical techniques. 

7 ‘‘(2) QUALITY REQUIREMENTS FOR LABORA8 TORIES CERTIFIED TO CONDUCT HIGH-COMPLEXITY

9 TESTS.—Quality requirements applicable to the in 

10 vitro clinical tests and developers described in sub11 section (a)(2) shall— 

12 ‘‘(A) avoid duplication of regulations under 

13 section 353 of the Public Health Service Act; 

14 and 

15 ‘‘(B) consist of, as directed related to the 

16 design and development— 

17 ‘‘(i) design controls; 

18 ‘‘(ii) purchasing controls; 

19 ‘‘(iii) acceptance activities; 

20 ‘‘(iv) corrective and preventative ac21 tion; and 

22 ‘‘(v) records. 

23 ‘‘(3) QUALITY REQUIREMENTS FOR CERTAIN

24 LABORATORIES DISTRIBUTING IN VITRO CLINICAL


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1 TESTS OR TEST PROTOCOLS WITHIN ORGANIZATIONS

2 OR PUBLIC HEALTH NETWORKS.— 

3 ‘‘(A) IN GENERAL.—Quality requirements 

4 applicable to the developer who is distributing 

5 in vitro clinical test distributed as described in 

6 subparagraph (B) shall consist of the following: 

7 ‘‘(i) The requirements in paragraph 

8 (2). 

9 ‘‘(ii) The labeling requirements in 

10 paragraph (1)(C)(xii). 

11 ‘‘(iii) The requirement to maintain 

12 records of the laboratories to which the in 

13 vitro clinical test or test protocol is distrib14 uted. 

15 ‘‘(B) DISTRIBUTING LABORATORY.—Sub16 paragraph (A) shall apply to developers that 

17 meet the following conditions: 

18 ‘‘(i) The laboratory distributing the 

19 test protocol is certified by the Secretary 

20 under section 353 of the Public Health 

21 Service Act and meets the requirements for 

22 performing high-complexity testing. 

23 ‘‘(ii) The laboratory develops its own 

24 in vitro clinical test or modifies another deVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00126 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 veloper’s in vitro clinical test in a manner 

2 described in section 587(6)(C). 

3 ‘‘(iii) The laboratory distributes the in 

4 vitro clinical test or test protocol for such 

5 test only to another laboratory that— 

6 ‘‘(I) is certified by the Secretary 

7 under section 353 of the Public 

8 Health Service Act and meets the re9 quirements for performing high-com10 plexity testing; 

11 ‘‘(II) is within the same cor12 porate organization and having com13 mon ownership by the same parent 

14 corporation; or as applicable, is a lab15 oratory within a public health labora16 tory network coordinated or managed 

17 by the Centers for Disease Control 

18 and Prevention; and 

19 ‘‘(III) implements the test pro20 tocol without further modification. 

21 ‘‘(c) REGULATIONS.—In implementing quality re22 quirements for test developers under this section, the Sec23 retary shall— 

24 ‘‘(1) for purposes of facilitating international 

25 harmonization, consider whether the developer parVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00127 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 ticipates in an audit program in which the United 

2 States participates or the United States recognizes 

3 or conforms with standards recognized by the Sec4 retary; and 

5 ‘‘(2) ensure a least burdensome approach de6 scribed in section 587B(j) by leveraging, to the ex7 tent applicable, the quality assurance requirements 

8 applicable to developers certified by the Secretary 

9 under section 353 of the Public Health Service Act. 

10 ‘‘SEC. 587K. LABELING REQUIREMENTS. 

11 ‘‘(a) IN GENERAL.—An in vitro clinical test shall 

12 bear or be accompanied by labeling, and a label as applica13 ble, that meet the requirements set forth in subsections 

14 (b) and (c), unless such test is exempt as specified in sub15 section (d) or (e). 

16 ‘‘(b) LABELS.— 

17 ‘‘(1) IN GENERAL.—The label of an in vitro 

18 clinical test shall meet the requirements set forth in 

19 paragraph (2), except this requirement shall not 

20 apply to an in vitro clinical test that— 

21 ‘‘(A) consists solely of a test protocol; or 

22 ‘‘(B) is developed, manufactured, and used 

23 solely within a single laboratory certified by the 

24 Secretary under section 353 of the Public 


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1 Health Service Act that meets the requirements 

2 for performing high-complexity testing. 

3 ‘‘(2) REGULATIONS.—The label of an in vitro 

4 clinical test shall state the name and place of busi5 ness of its developer and meet the requirements set 

6 forth in regulations promulgated under this section. 

7 ‘‘(c) LABELING.— 

8 ‘‘(1) IN GENERAL.—Labeling accompanying an 

9 in vitro clinical test, including labeling in the form 

10 of a package insert, standalone laboratory reference 

11 document, or other similar document except the la12 beling specified in paragraph (2), shall include ade13 quate directions for use and shall meet the require14 ments set forth in regulations promulgated under 

15 this section, except as provided in subsection (d) or 

16 (e). 

17 ‘‘(2) CONTENT.— 

18 ‘‘(A) IN GENERAL.—Labeling accom19 panying an in vitro clinical test that is in the 

20 form of a test report template or ordering infor21 mation shall include— 

22 ‘‘(i) the test listing number that was 

23 provided to the developer at the time of 

24 listing; 


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1 ‘‘(ii) instructions for how and where 

2 to report an adverse event under section 

3 587L; 

4 ‘‘(iii) instructions for how and where 

5 to access the performance summary data 

6 displayed in the listing database for the 

7 test; 

8 ‘‘(iv) the intended use of the in vitro 

9 clinical test; and 

10 ‘‘(v) any warnings, contraindications, 

11 or limitations. 

12 ‘‘(B) PUBLIC AVAILABILITY OF INFORMA13 TION.—The Secretary shall make all of the in14 formation described in subparagraph (A) with 

15 respect to each in vitro clinical test available to 

16 the public, as applicable, in accordance with 

17 section 587T, except to the extent that the Sec18 retary determines that such information is— 

19 ‘‘(i) trade secret or commercial con20 fidential information; or 

21 ‘‘(ii) national security or counter22 measures or is restricted from disclosure 

23 pursuant to another provision of law. 

24 ‘‘(3) ADDITIONAL REQUIREMENTS.—Labeling 

25 for an in vitro clinical test used for 


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1 immunohematology testing shall meet the applicable 

2 requirements set forth in part 660 of title 21, Code 

3 of Federal Regulations (or any successor regula4 tions), related to the labeling of blood grouping re5 agents, reagent red blood cells, and anti-human 

6 globulin. 

7 ‘‘(d) EXEMPTIONS AND ALTERNATIVE REQUIRE8 MENTS.— 

9 ‘‘(1) IN GENERAL.— 

10 ‘‘(A) IN GENERAL.—With respect to an in 

11 vitro clinical test that meets the criteria of sub12 paragraph (B), the ‘state in one place’ regula13 tions under section 809.10(b) of title 21 of the 

14 Code of Federal Regulations (or any successor 

15 regulations) may be satisfied by the laboratory 

16 posting such information on its website or in 

17 multiple documents, if such documents are 

18 maintained and accessible in one place. 

19 ‘‘(B) APPLICABLE TESTS.—An in vitro 

20 clinical test meets the criteria of this subpara21 graph if such test is— 

22 ‘‘(i) designed and manufactured by a 

23 laboratory certified by the Secretary under 

24 section 353 of the Public Health Service 


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1 Act that meets the requirements for per2 forming high-complexity testing; and 

3 ‘‘(ii) performed in the same laboratory 

4 in which it was developed or by another 

5 such laboratory certified by the Secretary 

6 under section 353 of the Public Health 

7 Service Act that meets the requirements 

8 for performing high complexity testing and 

9 is under common ownership with the lab10 oratory that designed and manufactured 

11 the test. 

12 ‘‘(2) TEST INSTRUMENT LABELING.—The label13 ing for an instrument is not required to bear the in14 formation indicated in paragraphs (3), (4), (5), (7), 

15 (8), (9), (10), (11), (12), and (13) of section 

16 809.10(b) of title 21 of the Code of Federal Regula17 tions (or any successor regulations). 

18 ‘‘(3) REAGENT LABELING.—For purposes of 

19 compliance with subsection (c)(1), the labeling for a 

20 reagent intended for use as a replacement in an in 

21 vitro clinical test may be limited to that information 

22 necessary to identify the reagent adequately and to 

23 describe its proper use in the system. 

24 ‘‘(4) LAB RESEARCH OR INVESTIGATIONAL

25 USE.—A shipment or other delivery of an in vitro 


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1 clinical test for research or investigational use pur2 suant to section 587A(m) shall be exempt from the 

3 labeling requirements of subsections (b) and (c)(1) 

4 and from any standard promulgated through regula5 tions, except as required under section 353 of the 

6 Public Health Service Act or section 587R of this 

7 Act. 

8 ‘‘(5) GENERAL PURPOSE LABORATORY RE9 AGENTS.—The labeling of general purpose labora10 tory reagents (such as hydrochloric acid) whose uses 

11 are generally known by persons trained in their use 

12 need not bear the directions for use required by sub13 sections (b) and (c)(1). 

14 ‘‘(6) ANALYTE SPECIFIC REAGENTS.—The la15 beling for analyte specific reagents shall bear the fol16 lowing statement: ‘This product is intended solely 

17 for further development of an in vitro clinical test 

18 and is exempt from most FDA regulation. This 

19 product must be evaluated by the in vitro clinical 

20 test developer in accordance with applicable require21 ments.’. If the labeling of an analyte specific reagent 

22 bears the statement set forth in this paragraph, it 

23 need not bear the information required by subsection 

24 (c)(1). 


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1 ‘‘(7) OVER-THE-COUNTER TEST SAMPLE COL2 LECTION SYSTEMS LABELING.—The labeling for 

3 over-the-counter test sample collection systems for 

4 drugs of abuse testing shall bear the name and place 

5 of business of the developer included in the registra6 tion listing under section 587I, in language appro7 priate for the intended users. 

8 ‘‘(e) TESTS IN THE STRATEGIC NATIONAL STOCK9 PILE.— 

10 ‘‘(1) IN GENERAL.—The Secretary may grant 

11 an exception or alternative to any provision listed in 

12 this section, unless explicitly required by a statutory 

13 provision outside this subchapter, for specified lots, 

14 batches, or other units of an in vitro clinical test, if 

15 the Secretary determines that compliance with such 

16 labeling requirement could adversely affect the safe17 ty, effectiveness, or availability of such products that 

18 are or will be included in the Strategic National 

19 Stockpile under section 319F–2 of the Public Health 

20 Service Act. 

21 ‘‘(2) REGULATIONS.—The Secretary may issue 

22 regulations amending section 809.11 of title 21 of 

23 the Code of Federal Regulations or any successor 

24 regulation to apply in full or in part to in vitro clin25 ical tests and in vitro clinical test developers. 


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1 ‘‘(f) GUIDANCE.—The Secretary may, in collabora2 tion with developers, issue guidance on standardized, gen3 eral content and format for in vitro clinical test labeling 

4 to help ensure compliance with applicable requirements in 

5 this subsection. 

6 ‘‘SEC. 587L. ADVERSE EVENT REPORTING. 

7 ‘‘(a) APPLICABILITY.— 

8 ‘‘(1) IN GENERAL.—Each in vitro clinical test 

9 developer shall establish and maintain a system for 

10 reporting adverse events in accordance with sub11 section (b), except as provided in section 587A. 

12 ‘‘(2) REGULATIONS.—The Secretary shall pro13 mulgate regulations to implement this section, in14 cluding information necessary to be reported to en15 sure the analytical and clinical validity of in vitro 

16 clinical tests, and the safety of articles for taking or 

17 deriving specimens from the human body. 

18 ‘‘(b) ADVERSE EVENT REPORTING REQUIRE19 MENTS.—Each developer shall report to the Secretary 

20 whenever information that reasonably suggests that one 

21 of the developer’s in vitro clinical tests is associated with 

22 an adverse event becomes known to the developer. 

23 ‘‘(c) REPORTS.—Reports required under this section 

24 shall be submitted as follows: 


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1 ‘‘(1) An individual adverse event report shall be 

2 submitted for the following events not later than— 

3 ‘‘(A) 5 calendar days after an in vitro clin4 ical test developer receives or otherwise becomes 

5 aware of information that reasonably suggests 

6 the adverse event involves a patient death; or 

7 ‘‘(B) 5 calendar days after an in vitro clin8 ical test developer receives or otherwise becomes 

9 aware of information that reasonably suggests 

10 the event presents an imminent threat to public 

11 health. 

12 ‘‘(2) Quarterly reports shall be submitted for all 

13 other adverse events, if any, and no later than the 

14 end of the quarter following the quarter in which the 

15 adverse event information was received by the in 

16 vitro clinical test developer. 

17 ‘‘(d) DEFINITIONS.—In this section— 

18 ‘‘(1) the term ‘adverse event’— 

19 ‘‘(A) means— 

20 ‘‘(i) death of, or serious injury to, a 

21 specific patient or user for which it is rea22 sonably believed that an in vitro clinical 

23 test error contributed to such death or se24 rious injury; or 


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1 ‘‘(ii) an in vitro clinical test error that 

2 may have reasonable likelihood to cause se3 rious injury or death; and 

4 ‘‘(B) excludes laboratory errors that are 

5 subject to the requirements of section 353 of 

6 the Public Health Service Act and corrective or 

7 preventive actions to prevent such errors; 

8 ‘‘(2) the term ‘in vitro clinical test error’— 

9 ‘‘(A) means a failure in an in vitro clinical 

10 test to meet the analytical or clinical validity 

11 standard or otherwise perform as intended by 

12 the developer; and 

13 ‘‘(B) includes an inaccurate false result 

14 that reaches a health care provider, patient, or 

15 consumer, except that such term excludes any 

16 such event or error related to laboratory oper17 ations pursuant to section 353 of the Public 

18 Health Service Act; and 

19 ‘‘(3) the term ‘serious injury’ means— 

20 ‘‘(A) a significant delay in a critical diag21 nosis or causing the absence, delay, or dis22 continuation of critical medical treatment or 

23 that irreversibly or seriously and negatively al24 ters the course of the disease or condition; or 

25 ‘‘(B) an injury that— 


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1 ‘‘(i) is life threatening; 

2 ‘‘(ii) results in permanent impairment 

3 of a body function or permanent damage 

4 to a body structure; or 

5 ‘‘(iii) necessitates medical or surgical 

6 intervention to preclude permanent impair7 ment of a body function or permanent 

8 damage to a body structure. 

9 ‘‘SEC. 587M. CORRECTIONS AND REMOVALS. 

10 ‘‘(a) IN GENERAL.—The Secretary shall promulgate 

11 regulations to implement this section, including informa12 tion necessary to be reported to ensure the analytical and 

13 clinical validity of in vitro clinical tests, and the safety of 

14 specimen receptacles. 

15 ‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.— 

16 ‘‘(1) IN GENERAL.—Each in vitro clinical test 

17 developer or importer shall report to the Secretary 

18 any correction or removal of an in vitro clinical test 

19 undertaken by such developer or importer if the re20 moval or correction was undertaken— 

21 ‘‘(A) to reduce the risk to health posed by 

22 the in vitro clinical test; or 

23 ‘‘(B) to remedy a violation of this Act 

24 caused by the in vitro clinical test which may 

25 present a risk to health. 


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1 ‘‘(2) EXCEPTION.—No report of the correction 

2 or removal of an in vitro clinical test is required 

3 under paragraph (1) if a report of the correction or 

4 removal is required under, and has been submitted 

5 under, section 587L. 

6 ‘‘(c) TIMING.—A developer or importer shall submit 

7 any report required under this subsection to the Secretary 

8 within 15 business days of initiating such correction or 

9 removal. 

10 ‘‘(d) RECORDKEEPING.—A developer or importer of 

11 an in vitro clinical test who undertakes a correction or re12 moval of an in vitro clinical test which is not required to 

13 be reported under this subsection shall keep a record of 

14 such correction or removal. 

15 ‘‘(e) RECALL COMMUNICATIONS.—Upon the vol16 untary reporting of a correction or removal by the devel17 oper— 

18 ‘‘(1) the Secretary shall classify such correction 

19 or removal under this section within 15 calendar 

20 days; and 

21 ‘‘(2) not later than 45 calendar days after the 

22 developer or other responsible party notifies the Sec23 retary that it has completed a recall action, the Sec24 retary shall provide the developer or other respon25 sible party with a written statement closing the reVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00139 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 call action or stating the reasons the Secretary can2 not close the recall at that time. 

3 ‘‘(f) LIMITATION.—The developer is not required to 

4 report a correction or removal of an in vitro clinical test 

5 based solely on an adverse event report under section 

6 587L that captures an error within the approved perform7 ance standards for such test. 

8 ‘‘(g) DEFINITIONS.—For purposes of this section— 

9 ‘‘(1) the term ‘correction’ means the repair, 

10 modification, adjustment, relabeling, destruction, or 

11 inspection (including patient monitoring) of an in 

12 vitro clinical test without its physical removal from 

13 its point of use to another location, and does not in14 clude routine servicing; and 

15 ‘‘(2) the term ‘removal’ means the physical re16 moval of an in vitro clinical test from its point of use 

17 to another location for repair, modification, adjust18 ment, relabeling, destruction, or inspection, and does 

19 not include routine servicing. 

20 ‘‘SEC. 587N. RESTRICTED IN VITRO CLINICAL TESTS. 

21 ‘‘(a) APPLICABILITY.— 

22 ‘‘(1) IN GENERAL.—The Secretary, in issuing 

23 an approval of an in vitro clinical test under section 

24 587B of a category described in paragraph (3) may 

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1 tion, or use upon such conditions as the Secretary 

2 may prescribe under paragraph (2). 

3 ‘‘(2) CONDITIONS PRESCRIBED BY THE SEC4 RETARY.—The conditions prescribed by the Sec5 retary under this paragraph, with respect to an in 

6 vitro clinical test described in paragraph (3), are 

7 those conditions which the Secretary determines due 

8 to the potentiality for harmful effect of such test (in9 cluding any resulting absence, delay, or discontinu10 ation of appropriate medical treatment), are nec11 essary to assure the analytical or clinical validity of 

12 the test, or the safety of a specimen receptacle. 

13 ‘‘(3) IN VITRO CLINICAL TESTS SUBJECT TO

14 RESTRICTIONS.—The restrictions authorized under 

15 this section may be applied by the Secretary to any 

16 high-risk in vitro clinical test, prescription home-use 

17 in vitro clinical test, direct-to-consumer in vitro clin18 ical test, or over-the-counter in vitro clinical test. 

19 ‘‘(b) LABELING AND ADVERTISING OF A RESTRICTED

20 IN VITRO CLINICAL TEST.—The label, labeling, and ad21 vertising of an in vitro clinical test to which restrictions 

22 apply under subsection (a) shall bear such appropriate 

23 statements of the restrictions as the Secretary may pre24 scribe in the approval, provisional approval, technology 

25 certification, or regulation, as applicable. 


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1 ‘‘(c) REQUIREMENTS PRIOR TO ENACTMENT.—An in 

2 vitro clinical test that was offered, sold, or distributed as 

3 a restricted device prior to the enactment date of this sub4 chapter shall continue to comply with the applicable re5 strictions under section 515 or section 520(e) until the 

6 effective date of restrictions issued under subsection (a). 

7 ‘‘SEC. 587O. APPEALS. 

8 ‘‘(a) SIGNIFICANT DECISION.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall provide 

10 a substantive summary of the scientific and regu11 latory rationale for any significant decision of the 

12 Center for Devices and Radiological Health regard13 ing submission of an application for, or a review of, 

14 an in vitro clinical test under section 587B or sec15 tion 587D or regarding an exemption under section 

16 587A, including documentation of significant con17 troversies or differences of opinion and the resolu18 tion of such controversies or differences of opinion. 

19 ‘‘(2) PROVISION OF DOCUMENTATION.—Upon 

20 request, the Secretary shall furnish a substantive 

21 summary described in paragraph (1) to the person 

22 who has made, or is seeking to make, a submission 

23 described in such paragraph. 

24 ‘‘(3) APPLICATION OF LEAST BURDENSOME RE25 QUIREMENTS.—The substantive summary required 


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1 under this subsection shall include a brief statement 

2 regarding how the least burdensome requirements 

3 were considered and applied consistent with section 

4 587B(j), as applicable. 

5 ‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 

6 ‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF

7 SIGNIFICANT DECISION.—Any person may request a 

8 supervisory review of the significant decision de9 scribed in subsection (a)(1). Such review may be 

10 conducted at the next supervisory level or higher 

11 above the agency official who made the significant 

12 decision. 

13 ‘‘(2) SUBMISSION OF REQUEST.—A person re14 questing a supervisory review under paragraph (1) 

15 shall submit such request to the Secretary not later 

16 than 30 days after the decision for which the review 

17 is requested and shall indicate in the request wheth18 er such person seeks an in-person meeting or a tele19 conference review. 

20 ‘‘(3) TIMEFRAME.—The Secretary shall sched21 ule an in-person or teleconference review, if so re22 quested, not later than 30 days after such request 

23 is made. The Secretary shall issue a decision to the 

24 person requesting a review under this subsection not 

25 later than 45 days after the request is made under 


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1 paragraph (1), or, in the case of a person who re2 quests an in-person meeting or teleconference, 30 

3 days after such meeting or teleconference. 

4 ‘‘(c) ADVISORY PANELS.—The process established 

5 under subsection (a) shall permit the appellant to request 

6 review by an advisory committee established under section 

7 513 or 587G. The Secretary shall provide a response to 

8 an appellant under this subsection not later than 45 days 

9 after the requested advisory committee is convened. 

10 ‘‘SEC. 587P. ACCREDITED PERSONS. 

11 ‘‘(a) IN GENERAL.— 

12 ‘‘(1) REVIEW OF APPLICATIONS.— 

13 ‘‘(A) ACCREDITATION FOR APPLICATION

14 REVIEW.—Subject to subparagraph (C), during 

15 the period beginning on the date of enactment 

16 of the Verifying Accurate Leading-edge IVCT 

17 Development Act of 2021 and ending 2 years 

18 after the date of enactment of such Act, the 

19 Secretary shall accredit persons for any of the 

20 following purposes: 

21 ‘‘(i) Reviewing applications for pre22 market approval under section 587B and 

23 applications for technology certification 

24 under section 587D. 


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1 ‘‘(ii) Making recommendations to the 

2 Secretary with respect to an approval of an 

3 application under section 587B or issuance 

4 of a technology certification order under 

5 section 587D. 

6 ‘‘(B) REQUIREMENT REGARDING REVIEW

7 RECOMMENDATIONS.— 

8 ‘‘(i) IN GENERAL.—In making a rec9 ommendation to the Secretary under this 

10 section, an accredited person shall notify 

11 the Secretary in writing of the reasons for 

12 the recommendation concerning the appli13 cation. 

14 ‘‘(ii) TIME PERIOD FOR REVIEW.— 

15 Not later than 30 calendar days after the 

16 date on which the Secretary is notified of 

17 a recommendation under this section with 

18 respect to an application for premarket ap19 proval or technology certification, the Sec20 retary shall make a determination with re21 spect to the application. 

22 ‘‘(C) LACK OF APPLICATIONS WITHIN 2- 

23 YEAR TIMEFRAME.—If the Secretary does not 

24 receive applications from persons that meet the 


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1 criteria under subsection (c) within such period, 

2 the Secretary— 

3 ‘‘(i) may accredit persons under this 

4 paragraph after the 2-year period de5 scribed in subparagraph (A); and 

6 ‘‘(ii) shall issue a public notice on the 

7 website of the Food and Drug Administra8 tion calling for applications for such ac9 creditation. 

10 ‘‘(2) INSPECTIONS.— 

11 ‘‘(A) ACCREDITATION FOR INSPECTIONS.— 

12 Subject to subparagraph (B), during the period 

13 beginning on the date of enactment of the 

14 Verifying Accurate Leading-edge IVCT Devel15 opment Act of 2021 and ending 2 years after 

16 the date of enactment of such Act, the Sec17 retary shall accredit persons for the purpose of 

18 conducting inspections of in vitro clinical test 

19 developers and other persons required to reg20 ister pursuant to section 587I. 

21 ‘‘(B) LACK OF APPLICATIONS WITHIN 2- 

22 YEAR TIMEFRAME.—If no persons who meet the 

23 criteria for such accreditation apply during the 

24 2-year period described in subparagraph (A), 

25 the Secretary— 


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1 ‘‘(i) may accredit persons under this 

2 subparagraph after such period; and 

3 ‘‘(ii) shall issue a public notice on the 

4 website of the Food and Drug Administra5 tion calling for applications for such ac6 creditation. 

7 ‘‘(C) EFFECT OF ACCREDITATION.— 

8 ‘‘(i) IN GENERAL.—Persons accredited 

9 under subparagraph (A) to conduct inspec10 tions, when conducting such inspections, 

11 shall record in writing their specific obser12 vations and shall present their observations 

13 to the designated representative of the in14 spected establishment. 

15 ‘‘(ii) INSPECTION REPORT REQUIRE16 MENTS.—Each person accredited under 

17 this paragraph shall prepare and submit to 

18 the Secretary an inspection report in a 

19 form and manner designated by the Sec20 retary for conducting inspections, taking 

21 into consideration the goals of inter22 national harmonization of quality systems 

23 standards. Any official classification of the 

24 inspection shall be determined by the Sec25 retary. Any statement or representation 


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1 made by an employee or agent of an estab2 lishment to a person accredited to conduct 

3 inspections shall be subject to section 1001 

4 of title 18, United States Code. 

5 ‘‘(D) SAVINGS CLAUSE.—Nothing in this 

6 section affects the authority of the Secretary to 

7 inspect any in vitro clinical test developer or 

8 other person registered under section 587I. 

9 ‘‘(E) INSPECTION LIMITATIONS.—The Sec10 retary shall ensure that inspections carried out 

11 under this section are not duplicative of inspec12 tions carried out under section 353 of the Pub13 lic Health Service Act. Inspections under this 

14 section shall be limited to the data and informa15 tion necessary— 

16 ‘‘(i) for routine surveillance activities 

17 associated with applications under sections 

18 587B and 587D; or 

19 ‘‘(ii) to meet the requirements to re20 ceive premarket approval under section 

21 587B or a technology certification order 

22 under section 587D, as applicable. 

23 ‘‘(b) ACCREDITATION.— 

24 ‘‘(1) ACCREDITATION PROGRAM.— 


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1 ‘‘(A) IN GENERAL.—The Secretary may 

2 provide for accreditation under this section 

3 through programs administered by the Food 

4 and Drug Administration, by other non-Federal 

5 government agencies, or by qualified nongovern6 mental organizations. A person may be accred7 ited for the review of both applications sub8 mitted under sections 587B and 587D as de9 scribed in subsection (a)(1)(A) and to conduct 

10 inspection activities under subsection (a)(2)(A), 

11 or for a subset of such review or activities. 

12 ‘‘(B) ELIGIBLE PERSONS.—Not later than 

13 180 days after the date of enactment of the 

14 Verifying Accurate Leading-edge IVCT Devel15 opment Act of 2021, the Secretary shall issue 

16 draft guidance on the criteria that the Sec17 retary will use to accredit or deny accreditation 

18 to a person who requests such accreditation 

19 under subsection (a), and not later than one 

20 year after the close of the comment period for 

21 the draft guidance issued in this section, issue 

22 final guidance. 

23 ‘‘(C) REQUIREMENTS.— 

24 ‘‘(i) IN GENERAL.—The Secretary 

25 shall not accredit or maintain accreditation 


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1 for a person unless such person meets the 

2 minimum qualifications required under 

3 subsection (c). 

4 ‘‘(ii) SCOPE OF ACCREDITATION.— 

5 The accreditation of a person under this 

6 section shall specify the particular activi7 ties under subsection (a) for which such 

8 person is accredited. 

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 ‘‘(2) ACCREDITATION PROCESS.— 

17 ‘‘(A) ACCREDITATION PROCESS GUID18 ANCE.—The Secretary shall— 

19 ‘‘(i) not later than 180 days after the 

20 date of enactment of the Verifying Accu21 rate Leading-edge IVCT Development Act 

22 of 2021, issue draft guidance specifying 

23 the process for submitting a request for 

24 each type of accreditation and reaccredita25 tion under this section, including the form 


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1 and content of information to be submitted 

2 in such a request; and 

3 ‘‘(ii) not later than 1 year after the 

4 close of the comment period for the draft 

5 guidance, issue final guidance. 

6 ‘‘(B) RESPONSE TO REQUEST.—The Sec7 retary shall respond to a request for accredita8 tion or reaccreditation within 60 calendar days 

9 of the receipt of the request. The Secretary’s 

10 response may be to accredit or reaccredit the 

11 person, to deny accreditation, or to request ad12 ditional information in support of the request. 

13 If the Secretary requests additional informa14 tion, the Secretary shall respond within 60 cal15 endar days of receipt of such additional infor16 mation to accredit or deny the accreditation. 

17 ‘‘(C) TYPE OF ACCREDITATION.—The ac18 creditation or reaccreditation of a person shall 

19 specify the particular activity or activities under 

20 subsection (a) for which such person is accred21 ited, and shall include any limitation to certain 

22 eligible in vitro clinical tests. 

23 ‘‘(D) AUDIT.—The Secretary may audit 

24 the performance of persons accredited under 

25 this section for purposes of ensuring that such 


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1 persons continue to meet the published criteria 

2 for accreditation, and may modify the scope or 

3 particular activities for which a person is ac4 credited if the Secretary determines that such 

5 person fails to meet one or more criteria for ac6 creditation. 

7 ‘‘(E) SUSPENSION OR WITHDRAWAL.—The 

8 Secretary may suspend or withdraw accredita9 tion of any person accredited under this section, 

10 after providing notice and an opportunity for an 

11 informal hearing, when such person is substan12 tially not in compliance with the requirements 

13 of this section or the published criteria for ac14 creditation, or poses a threat to public health, 

15 or fails to act in a manner that is consistent 

16 with the purposes of this section. 

17 ‘‘(F) REACCREDITATION.—Accredited per18 sons may be initially accredited for up to 4 

19 years. After expiration of such initial period, 

20 persons may be reaccredited for unlimited addi21 tional 4-year periods, as determined by the Sec22 retary. 

23 ‘‘(c) QUALIFICATIONS OF ACCREDITED PERSONS.— 

24 ‘‘(1) ELIGIBILITY.—An accredited person, at a 

25 minimum, shall— 


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1 ‘‘(A) not be an employee of the Federal 

2 Government; 

3 ‘‘(B) not engage in the activities of a de4 veloper, as defined in section 587(7); 

5 ‘‘(C) not be a person required to register 

6 under section 587I, unless such person has es7 tablished sufficient processes and protocols to 

8 separate activities to develop in vitro clinical 

9 tests and the activities for which such person 

10 would be accredited under subsection (a) and 

11 discloses applicable information under this sec12 tion; 

13 ‘‘(D) not be owned or controlled by, and 

14 shall have no organizational, material or finan15 cial affiliation with, an in vitro clinical test de16 veloper or other person required to register 

17 under section 587I; 

18 ‘‘(E) be a legally constituted entity per19 mitted to conduct the activities for which it 

20 seeks accreditation; 

21 ‘‘(F) ensure that the operations of such 

22 person are in accordance with generally accept23 ed professional and ethical business practices; 

24 and 


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1 ‘‘(G) include in its request for accredita2 tion a commitment to, at the time of accredita3 tion and at any time it is performing activities 

4 pursuant to this section— 

5 ‘‘(i) certify that the information re6 ported to the Secretary accurately reflects 

7 the data or protocol reviewed, and the doc8 umented inspection findings, as applicable; 

9 ‘‘(ii) limit work to that for which com10 petence and capacity are available; 

11 ‘‘(iii) treat information received or 

12 learned, records, reports, and recommenda13 tions as proprietary information of the per14 son submitting such information; and 

15 ‘‘(iv) in conducting the activities for 

16 which the person is accredited in respect to 

17 a particular in vitro clinical test, protect 

18 against the use of any employee or consult19 ant who has a financial conflict of interest 

20 regarding that in vitro clinical test. 

21 ‘‘(2) WAIVER.—The Secretary may waive any 

22 requirements in subparagraph (A), (B), (C), or (D) 

23 of paragraph (1) upon making a determination that 

24 such person has implemented other appropriate conVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00154 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 trols sufficient to ensure a competent and impartial 

2 review. 

3 ‘‘(d) COMPENSATION OF ACCREDITED PERSONS.— 

4 ‘‘(1) IN GENERAL.—Compensation of an ac5 credited person who reviews an application for pre6 market approval submitted under section 587B or 

7 an application for technical certification submitted 

8 under section 587D shall be determined by agree9 ment between the accredited person and the person 

10 who engages the services of the accredited person, 

11 and shall be paid by the person who engages such 

12 services. 

13 ‘‘(2) INSPECTION ACCREDITATION.—Compensa14 tion of an accredited person who is conducting an 

15 inspection under section 704 shall be determined by 

16 agreement between the accredited person and the 

17 person who engages the services of the accredited 

18 person, and shall be paid by the person who engages 

19 such services. 

20 ‘‘(e) COOPERATIVE AGREEMENTS.—The Secretary is 

21 authorized to enter into cooperative arrangements with of22 ficials of foreign countries to ensure that adequate and 

23 effective means are available for purposes of determining, 

24 from time to time, whether in vitro clinical tests intended 

25 for use in the United States by a person whose facility 


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1 is located outside the United States shall be refused ad2 mission on any of the grounds set forth in section 801(a). 

3 ‘‘(f) INFORMATION SHARING AGREEMENTS.—An ac4 credited person may enter into an agreement with a test 

5 developer to provide information to the comprehensive test 

6 information system under section 587T, including any re7 quirements under section 587I. 

8 ‘‘SEC. 587Q. RECOGNIZED STANDARDS. 

9 ‘‘(a) IN GENERAL.—The Secretary may by order es10 tablish performance standards for an in vitro clinical test 

11 or tests with the same indication for use to provide reason12 able assurance of the analytical validity, clinical validity, 

13 or as applicable safety, of that in vitro clinical test or tests 

14 with the same indications for use. 

15 ‘‘(b) OTHER STANDARDS.—The Secretary may recog16 nize all or part of appropriate standards established by 

17 nationally or internationally recognized standard develop18 ment organizations for which a person may submit a dec19 laration of conformity in order to meet a requirement 

20 under this subchapter to which that standard is applicable. 

21 In recognizing a standard, any person requesting recogni22 tion of a standard or seeking to use a recognized standard, 

23 the Secretary shall follow the processes and requirements, 

24 in accordance with section 514(c). Standards for in vitro 

25 diagnostic devices previously recognized under section 


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1 514(c) shall be considered recognized standards under this 

2 section. The application of any such consensus standard 

3 shall only apply prospectively. The Secretary shall issue 

4 guidance establishing the criteria and process for such rec5 ognition and adoption. 

6 ‘‘(c) ORDER PROCESS.—In establishing a standard 

7 under subsection (a), the Secretary shall issue a draft 

8 order proposing to establish a standard and shall provide 

9 for a comment period of not less than 60 calendar days. 

10 The Secretary may seek the recommendation of an advi11 sory committee under section 587G concerning a proposed 

12 standard either prior to or after issuance of a proposed 

13 order. After considering the comments and within 90 days 

14 of the close of the comment period, the Secretary shall 

15 issue a final order adopting the proposed standard, adopt16 ing a modification of the proposed standard or terminating 

17 the proceeding. 

18 ‘‘(d) AMENDMENT PROCESS.—The procedures estab19 lished in this section or in guidance issued under this sec20 tion shall apply to amendment of an existing standard. 

21 ‘‘SEC. 587R. INVESTIGATIONAL USE. 

22 ‘‘(a) IN GENERAL.—Except as provided in subsection 

23 (c), an in vitro clinical test for investigational use shall 

24 be exempt from the requirements of this subchapter other 

25 than sections 587A, 587O, and 587U. 


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1 ‘‘(b) REGULATIONS.—Not later than 2 years after 

2 the date of enactment of the Verifying Accurate Leading3 edge IVCT Development Act of 2021, the Secretary shall 

4 promulgate regulations to implement this section. 

5 ‘‘(c) APPLICATION FOR INVESTIGATIONAL USE.— 

6 ‘‘(1) IN GENERAL.—The following shall apply 

7 with respect to in vitro clinical tests for investiga8 tional use: 

9 ‘‘(A) STREAMLINING APPLICATIONS SUB10 MITTED UNDER THIS SECTION.—Requirements 

11 with respect to such tests shall be completed in 

12 accordance with current, at the time of submit13 ting the application, investigational use require14 ments for institutional review boards and cur15 rent processes for any analytical or clinical vali16 dation. 

17 ‘‘(B) VARIATION.—The requirements in 

18 the regulations promulgated under this section 

19 shall take into account variations based on— 

20 ‘‘(i) the scope and duration of clinical 

21 testing to be conducted under investigation 

22 that is the subject of such application; 

23 ‘‘(ii) the number of human subjects 

24 that are to be involved in such testing; 


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1 ‘‘(iii) the need to permit changes to be 

2 made in the in vitro clinical test involved 

3 during testing conducted in accordance 

4 with a plan required under paragraph 

5 (3)(B); or 

6 ‘‘(iv) whether the clinical testing of 

7 such in vitro clinical test is for the purpose 

8 of developing data to obtain approval to 

9 offer such test. 

10 ‘‘(C) SIGNIFICANT RISK STUDIES.—In the 

11 case of an in vitro clinical test the investiga12 tional use of which poses a significant risk, a 

13 sponsor of an investigation of such a test seek14 ing an investigational use exemption shall sub15 mit to the Secretary an investigational use ap16 plication with respect to the test in accordance 

17 with paragraphs (2) and (3). For purposes of 

18 this subparagraph, the term ‘significant risk’ 

19 means, with respect to an in vitro clinical test 

20 that is a high-risk test, and that the use of the 

21 test— 

22 ‘‘(i) is a use of substantial importance 

23 in performing an activity or activities de24 scribed in subsection (ss)(1)(A) for, a seri25 ous or life-threatening disease or condition 


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1 without confirmation of the diagnosis by a 

2 medically established means; 

3 ‘‘(ii) requires an invasive sampling 

4 procedure that presents a significant risk 

5 to the human subject; or 

6 ‘‘(iii) otherwise presents a reasonably 

7 foreseeable serious risk to the health of a 

8 human subject. 

9 ‘‘(D) NON-SIGNIFICANT RISK TESTS.—In 

10 the case of an in vitro clinical test, the inves11 tigational use of which does not pose a signifi12 cant risk— 

13 ‘‘(i) the sponsor of such investigation 

14 shall— 

15 ‘‘(I) conduct such investigation in 

16 compliance with an investigational 

17 plan specified in paragraph (5) and 

18 labeling specified in paragraph 

19 (3)(A)(ii); 

20 ‘‘(II) ensure each investigator ob21 tains informed consent under part 50 

22 of title 21, Code of Federal Regula23 tions (or any successor regulations), 

24 subject to the exceptions set forth in 

25 paragraphs (5)(A)(iii) and (5)(B); 


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1 ‘‘(III) submit a listing to the Sec2 retary of such investigation; and 

3 ‘‘(IV) maintain records with re4 spect to all requirements in this sub5 paragraph; and 

6 ‘‘(ii) the sponsor may rely on any ex7 ception or exemption identified in para8 graph (5)(B) or as established by the Sec9 retary in regulations issued under sub10 section (b). 

11 ‘‘(2) APPLICATION CONTENT.—An investiga12 tional use application shall be submitted in such 

13 time and manner and contain such information as 

14 the Secretary may require in regulation, and shall 

15 include an investigational plan for proposed clinical 

16 testing and assurances that the sponsor submitting 

17 the application will— 

18 ‘‘(A) establish and maintain records rel19 evant to the investigation of such in vitro clin20 ical test; and 

21 ‘‘(B) submit to the Secretary annual re22 ports of data obtained as a result of the inves23 tigational use of the in vitro clinical test during 

24 the period covered by the exemption that the 


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1 Secretary reasonably determines will enable the 

2 Secretary— 

3 ‘‘(i) to ensure compliance with the 

4 conditions for the exemption specified in 

5 paragraph (3); 

6 ‘‘(ii) to review the progress of the in7 vestigation involved; and 

8 ‘‘(iii) to evaluate the analytical valid9 ity and clinical validity of such test. 

10 ‘‘(3) CONDITIONS FOR EXEMPTION.— 

11 ‘‘(A) IN GENERAL.—A request for an in12 vestigational use exemption with respect to sig13 nificant risk tests shall be granted only if each 

14 of the following conditions is met: 

15 ‘‘(i) The risks to the subjects of the in 

16 vitro clinical test are outweighed by the an17 ticipated benefits to the subjects and the 

18 importance of the knowledge to be gained, 

19 and adequate assurance of informed con20 sent is provided in accordance with para21 graph (5)(A)(iii). 

22 ‘‘(ii) The proposed labeling for the in 

23 vitro clinical test involved clearly and con24 spicuously states ‘For investigational use’. 


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1 ‘‘(iii) Such other requirements the 

2 Secretary determines to be necessary for 

3 the protection of the public health and 

4 safety as long as the requirements do not 

5 unduly delay investigation after finding 

6 that the results of such investigation estab7 lish sufficient data to support clinical or 

8 analytical validity. 

9 ‘‘(B) CERTAIN SIGNIFICANT RISK IN VITRO

10 CLINICAL TESTS FOR AN UNMET NEED.—As a 

11 condition for granting an exemption under this 

12 paragraph, the Secretary shall not impose a 

13 limit on the sample size for a significant risk in 

14 vitro clinical test that meets the requirements 

15 of section 587C, as long as such test is devel16 oped within a laboratory that is certified to con17 duct high-complexity testing under section 353 

18 of the Public Health Service Act. 

19 ‘‘(4) COORDINATION WITH INVESTIGATIONAL

20 NEW DRUG APPLICATIONS.—Any requirement for 

21 the submission of a report to the Secretary pursuant 

22 to a request for an investigational new drug exemp23 tion involving an in vitro clinical test shall supersede 

24 the reporting requirement in paragraph (2)(B), but 

25 only to the extent the requirement with respect to 


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1 the request for exemption with respect to the drug 

2 is duplicative of the reporting requirement under 

3 such paragraph. 

4 ‘‘(5) INVESTIGATION PLAN REQUIREMENTS.— 

5 ‘‘(A) IN GENERAL.—With respect to an in6 vestigational plan submitted under paragraph 

7 (2)(A), the sponsor submitting such plan 

8 shall— 

9 ‘‘(i) in the case of such a plan sub10 mitted to an institutional review com11 mittee, promptly notify the Secretary of 

12 the approval or the suspension or termi13 nation of the approval of such plan by an 

14 institutional review committee; 

15 ‘‘(ii) in the case of an in vitro clinical 

16 test made available to investigators for 

17 clinical testing, assurance that all inves18 tigators will comply with this section, regu19 lations promulgated or revised under this 

20 section, and applicable human subjects reg21 ulations; and 

22 ‘‘(iii) submit an assurance to the Sec23 retary that informed consent will be ob24 tained from each human subject (or the 

25 representative of such subject) of proposed 


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1 clinical testing involving such in vitro clin2 ical test, except in the case that— 

3 ‘‘(I) there is a life-threatening 

4 situation involving the human subject 

5 of such testing which necessitates the 

6 use of such in vitro clinical test; 

7 ‘‘(II) it is not feasible to obtain 

8 informed consent from the subject; 

9 and 

10 ‘‘(III) there is not sufficient time 

11 to obtain such consent from a rep12 resentative of such subject. 

13 ‘‘(B) EXCEPTION.—The informed consent 

14 of human subjects shall not be required with re15 spect to clinical testing conducted as part of an 

16 investigation, if— 

17 ‘‘(i) the clinical testing uses remnants 

18 of specimens collected for routine clinical 

19 care or analysis that would have been dis20 carded, leftover specimens that were pre21 viously collected for other research pur22 poses, or specimens obtained from speci23 men repositories; 

24 ‘‘(ii) the identity of the subject of the 

25 specimen is not known to, and may not 


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1 readily be ascertained by, the investigator 

2 or any other individual associated with the 

3 investigation, including the sponsor; 

4 ‘‘(iii) any clinical information that ac5 companies the specimens does not make 

6 the specimen source identifiable to the in7 vestigator or any other individual associ8 ated with the investigation, including the 

9 sponsor; 

10 ‘‘(iv) the individuals caring for the 

11 human subjects as patients are different 

12 from, and do not share information about 

13 the patient with, the individuals conducting 

14 the investigation; and 

15 ‘‘(v) the specimens are provided to the 

16 investigators without personally identifiable 

17 information and the supplier of the speci18 mens has established policies and proce19 dures to prevent the release of personally 

20 identifiable information. 

21 ‘‘(d) REVIEW OF APPLICATIONS.— 

22 ‘‘(1) IN GENERAL.—The Secretary may issue 

23 an order approving an investigation as proposed, ap24 proving it with conditions or modifications, or dis25 approving it. 


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1 ‘‘(2) FAILURE TO ACT.—Unless the Secretary, 

2 not later than the date that is 30 calendar days 

3 after the date of the submission of an investigational 

4 use exemption request that meets the requirements 

5 of subsection (c)(2), issues an order under sub6 section (d)(1) and notifies the sponsor submitting 

7 the application, the request shall be treated as 

8 granted as of such date without further action by 

9 the Secretary. 

10 ‘‘(3) DISAPPROVAL.—The Secretary may deny 

11 an investigational use request submitted under this 

12 subsection if the Secretary determines that the in13 vestigation with respect to which the request is sub14 mitted does not conform to the requirements of sub15 section (c)(3). A listing of such denial submitted to 

16 the sponsor with respect to such a request shall con17 tain the order of disapproval and a complete state18 ment of the reasons for the Secretary’s denial of the 

19 request. 

20 ‘‘(e) WITHDRAWAL OF APPROVAL.— 

21 ‘‘(1) IN GENERAL.—The Secretary may, by ad22 ministrative order, withdraw an exemption granted 

23 under this section with respect to an in vitro clinical 

24 test, including an exemption granted based on the 

25 Secretary’s failure to act pursuant to subsection 


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1 (d)(2), if the Secretary determines that the test does 

2 not meet the applicable conditions under subsection 

3 (c)(3) for such exemption. 

4 ‘‘(2) OPPORTUNITY TO BE HEARD.— 

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graph (B), an order withdrawing the exemption 

7 granted under this section may be issued only 

8 after the Secretary provides the applicant or 

9 sponsor of the test with an opportunity for an 

10 informal hearing. 

11 ‘‘(B) EXCEPTION.—An order referred to in 

12 subparagraph (A) with respect to an exemption 

13 granted under this subsection may be issued on 

14 a preliminary basis before the provision of an 

15 opportunity for an informal hearing if the Sec16 retary determines that the continuation of test17 ing under the exemption will result in an unrea18 sonable risk to the public health. The Secretary 

19 will provide an opportunity for an informal 

20 hearing promptly following any preliminary ac21 tion under this subparagraph. 

22 ‘‘(f) CHANGES.— 

23 ‘‘(1) IN GENERAL.—The regulations promul24 gated under subsection (b) shall provide, with re25 spect to an in vitro clinical test for which an exempVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00168 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 tion under this subsection is in effect, procedures 

2 and conditions under which the changes to the test 

3 are allowed without the additional determination on 

4 a request for an exemption or submission of a sup5 plement to such a request. Such regulations shall 

6 provide that such a change may be made if— 

7 ‘‘(A) the sponsor or applicant determines, 

8 on the basis of credible information (as defined 

9 by the Secretary) that the change meets the 

10 conditions specified in paragraph (2); and 

11 ‘‘(B) the sponsor or applicant submits to 

12 the Secretary, not later than 5 calendar days 

13 after making the change, a notice of the 

14 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 (if any) 

25 involved 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; 

10 ‘‘(ii) the scientific soundness of a plan 

11 submitted under subsection (c)(5); or 

12 ‘‘(iii) the rights, safety, or welfare of 

13 the human subjects (if any) involved in the 

14 investigation. 

15 ‘‘(g) CLINICAL HOLD.— 

16 ‘‘(1) IN GENERAL.—At any time, the Secretary 

17 may impose a clinical hold with respect to an inves18 tigation of an in vitro clinical test if the Secretary 

19 makes a determination described in paragraph (2). 

20 The Secretary shall, in imposing such clinical hold, 

21 specify the basis for the clinical hold, including the 

22 specific information available to the Secretary which 

23 served as the basis for such clinical hold, and con24 firm such determination in writing. The applicant or 


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1 sponsor may immediately appeal any such deter2 mination pursuant to section 587O. 

3 ‘‘(2) DETERMINATION.—For purposes of para4 graph (1), a determination described in this sub5 paragraph with respect to a clinical hold is a deter6 mination that— 

7 ‘‘(A) the in vitro clinical test involved rep8 resents an unreasonable risk to the safety of 

9 the persons who are the subjects of the clinical 

10 investigation, taking into account the qualifica11 tions of the clinical investigators, information 

12 about the in vitro clinical test, the design of the 

13 clinical investigation, the condition for which 

14 the in vitro clinical test is to be investigated, 

15 and the health status of the subjects involved; 

16 ‘‘(B) the clinical hold should be issued for 

17 such other reasons as the Secretary may by 

18 regulation establish; or 

19 ‘‘(C) any written request to the Secretary 

20 from the sponsor of an investigation that a clin21 ical hold be removed shall receive a decision, in 

22 writing and specifying the reasons therefor, 

23 within 30 days after receipt of such request. 

24 Any such request shall include sufficient inforVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00171 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 mation to support the removal of such clinical 

2 hold. 

3 ‘‘SEC. 587S. COLLABORATIVE COMMUNITIES FOR IN VITRO 

4 CLINICAL TESTS. 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) For the purposes of facilitating community 

7 solutions and decision making with respect to in 

8 vitro clinical tests, the Secretary may participate in 

9 collaborative communities comprised of public and 

10 private participants that may provide recommenda11 tions and other advice to the Secretary on the devel12 opment and regulation of in vitro clinical tests. 

13 ‘‘(2) A collaborative community under this sec14 tion shall have broad representation of interested 

15 private and public-sector stakeholder communities 

16 and may include patients, care partners, academics, 

17 health care professionals, health care systems, 

18 payors, Federal and State agencies, entities respon19 sible for accrediting clinical laboratories, inter20 national regulatory bodies, test developers, or other 

21 interested entities or communities. 

22 ‘‘(b) GUIDANCE.—The Secretary shall issue a draft 

23 guidance not later than 180 days after the date of enact24 ment of the Verifying Accurate Leading-edge IVCT Devel25 opment Act of 2021, addressing the participation process 


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1 and framework to build consensus, and how the Secretary 

2 may consider, review, and implement recommendations 

3 under subsection (c). 

4 ‘‘(c) RECOMMENDATIONS.—A collaborative commu5 nity for in vitro clinical tests may make recommendations 

6 to the Secretary on matters including— 

7 ‘‘(1) mitigating measures for in vitro clinical 

8 tests; 

9 ‘‘(2) standards development activities and per10 formance standards for in vitro clinical tests or 

11 groups of such tests; 

12 ‘‘(3) scientific and clinical evidence to support 

13 new claims for in vitro clinical tests; 

14 ‘‘(4) new technologies and methodologies re15 lated to in vitro clinical tests; 

16 ‘‘(5) stakeholder communication and engage17 ment; and 

18 ‘‘(6) development of effective policies and proc19 esses, including to develop tests, and to regulate 

20 such tests in accordance with least burdensome re21 quirements described in section 587B(j). 

22 ‘‘(d) USE BY SECRETARY.— 

23 ‘‘(1) IN GENERAL.—The Secretary may adopt 

24 recommendations made under subsection (b), or oth25 erwise incorporate the feedback from collaborative 


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1 communities into regulatory decision making, 

2 through rulemaking or guidance, as appropriate. 

3 ‘‘(2) CLARIFICATION.—The Secretary is not re4 quired to adopt recommendations submitted by col5 laborative communities. 

6 ‘‘(e) TRANSPARENCY.—The Secretary shall— 

7 ‘‘(1) publish on the website of the Food and 

8 Drug Administration matters for which it is seeking 

9 comments or recommendations, in a timely manner; 

10 ‘‘(2) maintain a list of all collaborative commu11 nities in which the Secretary participates and make 

12 such list available on the website of the Food and 

13 Drug Administration; and 

14 ‘‘(3) post on the website of the Food and Drug 

15 Administration at least once every year a report on 

16 the recommendations it has adopted and rec17 ommendations it has not adopted from collaborative 

18 communities. 

19 ‘‘(f) PARTICIPATION.—The Secretary may participate 

20 in a collaborative community only if such community re21 quires members to disclose conflicts of interest and has 

22 established a process to address conflicts of interest. 

23 ‘‘(g) EXEMPTION.—The collaborative communities 

24 established and used in accordance with this section shall 


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1 be exempt from the Federal Advisory Committee Act (5 

2 U.S.C. App.). 

3 ‘‘SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM. 

4 ‘‘(a) PURPOSE.—For the purposes of improving the 

5 transparency of information on in vitro clinical tests and 

6 allowing patients and health care providers better access 

7 to information about in vitro clinical tests, the Secretary 

8 shall establish a comprehensive test information system. 

9 ‘‘(b) ESTABLISHMENT.—Not later than 2 years after 

10 the date of enactment of the Verifying Accurate Leading11 edge IVCT Development Act of 2021, the Secretary shall 

12 make available a comprehensive test information system 

13 for in vitro clinical tests that is designed to— 

14 ‘‘(1) provide a transparent interface on the 

15 website of the Food and Drug Administration for 

16 stakeholders, to the extent permitted by applicable 

17 law, to access the— 

18 ‘‘(A) regulatory pathway designation infor19 mation for each in vitro clinical test or tests 

20 with the same indications for use; 

21 ‘‘(B) registration and listing information 

22 provided by developers under section 587I, in23 cluding the use of a link for labels; 

24 ‘‘(C) adverse event reports submitted 

25 under section 587L; 


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1 ‘‘(D) reports of corrections and removals 

2 submitted under section 587M; and 

3 ‘‘(E) other information pertaining to an in 

4 vitro clinical test or tests with the same indica5 tions for use, as the Secretary determines ap6 propriate; and 

7 ‘‘(2) provide a secure portal for electronic sub8 mission, including applications and other in vitro 

9 clinical test submissions, registration and listing in10 formation, and adverse event reports. 

11 ‘‘(c) SUBMISSION FUNCTION.—The comprehensive 

12 test information system shall serve as the electronic sub13 mission service for test developers submitting information 

14 for applications under sections 587B and 587D. 

15 ‘‘SEC. 587U. PREEMPTION. 

16 ‘‘(a) IN GENERAL.—No State, Tribal, or local gov17 ernment (or political subdivision thereof) may establish or 

18 continue in effect any requirement related to the develop19 ment, manufacture, labeling, distribution, sale, or use of 

20 an in vitro clinical test that is different from, or in addi21 tion to, the requirements of this subchapter. 

22 ‘‘(b) EXCEPTIONS.—Subsection (a) shall not be con23 strued to affect the authority of a State, Tribal, or local 

24 government— 


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1 ‘‘(1) to license laboratory personnel, health care 

2 practitioners, or health care facilities or to regulate 

3 any aspect of a health care practitioner-patient rela4 tionship; or 

5 ‘‘(2) to enforce laws of general applicability, 

6 such as zoning laws, environmental laws, labor laws, 

7 and general business laws. 

8 ‘‘(c) CLARIFICATION.—This section shall not be con9 strued to shift liability to health care practitioners or other 

10 users. 

11 ‘‘SEC. 587V. ADULTERATION. 

12 ‘‘An in vitro clinical test shall be deemed to be adul13 terated: 

14 ‘‘(1) If it consists in whole or in part of any 

15 filthy, putrid, or decomposed substance. 

16 ‘‘(2) If it has been developed, prepared, packed, 

17 or held under insanitary conditions whereby it may 

18 have been contaminated with filth, or whereby it 

19 may have been rendered injurious to health. 

20 ‘‘(3) If its container or package is composed, in 

21 whole or in part, of any poisonous or deleterious 

22 substance which may render the contents injurious 

23 to health. 


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1 ‘‘(4) If it bears or contains, for purposes of 

2 coloring only, a color additive which is unsafe within 

3 the meaning of section 721(a). 

4 ‘‘(5) If its analytical or clinical validity, or with 

5 respect to a specimen receptacle, its safety, or its 

6 strength, purity, or quality, differs from or falls 

7 below that which it purports or is represented to 

8 possess. 

9 ‘‘(6) If it is required to be, declared to be, pur10 ports to be, or is represented as being, in conformity 

11 with any performance standard established or recog12 nized under section 587Q and is not in all respects 

13 in conformity with such standard. 

14 ‘‘(7) If it is required to be in conformity with 

15 a mitigating measure established under section 

16 587E and is not in all respects in conformity with 

17 such mitigating measure. 

18 ‘‘(8) If it fails to have an approved premarket 

19 application under section 587B unless such in vitro 

20 clinical test can be lawfully offered— 

21 ‘‘(A) for clinical use pursuant to an exemp22 tion under section 587A; 

23 ‘‘(B) for emergency use pursuant to an au24 thorization under section 564; or 


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1 ‘‘(C) for investigational use pursuant to 

2 section 587R. 

3 ‘‘(9) If it is not in conformity with any condi4 tion established under section 587B, 587D, or 564. 

5 ‘‘(10) If it purports to be an in vitro clinical 

6 test that is offered for clinical use subject to an ex7 emption under section 587A and it fails to meet or 

8 maintain any criteria, condition, or requirement of 

9 such exemption. 

10 ‘‘(11) If it has been granted an exemption 

11 under section 587R for investigational use, and the 

12 person granted such exemption or any investigator 

13 who uses such in vitro clinical test under such ex14 emption fails to comply with a requirement pre15 scribed by or under such section. 

16 ‘‘(12) If it fails to meet the quality require17 ments prescribed in or established under section 

18 587J (as applicable), or the methods used in, or fa19 cilities or controls used for, its development, manu20 facture, packing, storage, or installation are not in 

21 conformity with applicable requirements established 

22 under such section. 

23 ‘‘(13) If it has been developed, manufactured, 

24 processed, packed or held in any establishment, fac25 tory, or warehouse and the owner, operator or agent 


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1 of such establishment, factory, or warehouse delays, 

2 denies, or limits an inspection, or refuses to permit 

3 entry or inspection. 

4 ‘‘(14) If it is not in compliance with any restric5 tion required under section 587N. 

6 ‘‘SEC. 587W. MISBRANDING. 

7 ‘‘An in vitro clinical test shall be deemed to be mis8 branded: 

9 ‘‘(1) If its labeling is false or misleading in any 

10 particular. 

11 ‘‘(2) If in a package form unless it bears a label 

12 containing— 

13 ‘‘(A) the name and place of business of the 

14 test developer, manufacturer, packer, or dis15 tributor; and 

16 ‘‘(B) an accurate statement of the quantity 

17 of contents in terms of weight, measure, or nu18 merical count with respect to small packages, 

19 unless an exemption is granted by the Secretary 

20 by the issuance of guidance. 

21 ‘‘(3) If any word, statement, or other informa22 tion required by or under authority of this Act to 

23 appear on the label or labeling, including a test re24 port, is not prominently placed thereon with such 

25 conspicuousness (as compared with other words, 


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1 statements, designs, or devices, in the labeling) and 

2 in such terms as to render it likely to be read and 

3 understood by the ordinary individual under cus4 tomary conditions of purchase and use. 

5 ‘‘(4) Unless its labeling bears adequate direc6 tions for use and such adequate warnings as are 

7 necessary for the protection of users of the in vitro 

8 clinical test and recipients of the results of such in 

9 vitro clinical test, including patients, consumers, do10 nors, and related health care professionals. Required 

11 labeling for in vitro clinical tests intended for use in 

12 health care facilities or by a health care professional 

13 may be made available solely by electronic means, 

14 provided that the labeling complies with all applica15 ble requirements of law, and that the test developer, 

16 manufacturer, or distributor affords such users the 

17 opportunity to request the labeling in paper form, 

18 and after such request, promptly provides the re19 quested information without additional cost. 

20 ‘‘(5) If it causes serious or adverse health con21 sequences or death, including through absence, 

22 delay, or discontinuation in diagnosis or treatment, 

23 when used in the manner prescribed, recommended, 

24 or suggested in the labeling thereof. 


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1 ‘‘(6) If it was developed or manufactured in an 

2 establishment not duly registered under section 587I 

3 or it was not included in a listing under section 

4 587I, in accordance with timely reporting require5 ments under this subchapter. 

6 ‘‘(7) In the case of any in vitro clinical test sub7 ject to restrictions under section 587N, (1) if its ad8 vertising is false or misleading in any particular, (2) 

9 if it is offered for clinical use, sold, distributed, or 

10 used in violation of such restrictions, or (3) unless 

11 the test developer, manufacturer, or distributor in12 cludes in all advertisements and other descriptive 

13 printed matter that such person issues or causes to 

14 be issued, a brief statement of the intended uses of 

15 the in vitro clinical test and relevant warnings, pre16 cautions, side effects, and contraindications. This 

17 subsection shall not be applicable to any printed 

18 matter that the Secretary determines to be labeling 

19 as defined in section 201(m) or section 587K. 

20 ‘‘(8) If it was subject to a mitigating measure 

21 established under section 587E, unless it bears such 

22 labeling as may be prescribed in such mitigating 

23 measure. 


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1 ‘‘(9) If it was subject to a standard established 

2 under section 587Q, unless it bears such labeling as 

3 may be prescribed in such standard. 

4 ‘‘(10) Unless it bears such labeling as may be 

5 prescribed by or established under an applicable la6 beling requirement under this Act. 

7 ‘‘(11) If there was a failure or refusal to comply 

8 with any requirement prescribed under section 587I 

9 or 587X, or to comply with a requirement under sec10 tion 587Y, or to provide any report, material, or in11 formation required under this subchapter. 

12 ‘‘SEC. 587X. POSTMARKET SURVEILLANCE. 

13 ‘‘(a) IN GENERAL.— 

14 ‘‘(1) IN GENERAL.—In addition to other appli15 cable requirements under this Act, the Secretary 

16 may issue an order requiring a developer to conduct 

17 postmarket surveillance of a single in vitro clinical 

18 test as a condition of approval under section 587B. 

19 ‘‘(2) EXEMPT TESTS.—The Secretary may 

20 order postmarket surveillance for tests exempt pur21 suant to section 587A for which the failure of the 

22 in vitro clinical test to meet the applicable standard 

23 for approval is likely to result in serious or adverse 

24 health consequences or death from use of the single 

25 in vitro clinical test. 


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1 ‘‘(3) CONSIDERATION.—In determining whether 

2 to require a developer to conduct postmarket surveil3 lance of an in vitro clinical test, the Secretary shall 

4 take into consideration the benefits and risks for the 

5 patient and the least burdensome principles under 

6 section 587B. 

7 ‘‘(b) SURVEILLANCE APPROVAL.— 

8 ‘‘(1) Each developer required to conduct a sur9 veillance of an in vitro clinical test shall submit, 

10 within 30 days of receiving an order from the Sec11 retary, a plan for the required surveillance. The Sec12 retary, within 60 days of the receipt of such plan, 

13 shall determine if the person designated to conduct 

14 the surveillance has the appropriate qualifications 

15 and experience to undertake such surveillance and if 

16 the plan will result in useful data that can reveal un17 foreseen adverse events or other information nec18 essary to protect the health of patients or the public. 

19 ‘‘(2) The developer shall commence surveillance 

20 under this section not later than 15 months after 

21 the day on which the Secretary orders such postmar22 ket surveillance, unless the Secretary determines 

23 more time is needed to commence surveillance. 

24 ‘‘(3) The Secretary may order a prospective 

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1 tion by the Secretary that a longer period is nec2 essary shall be made by mutual agreement between 

3 the Secretary and the manufacturer or, if no agree4 ment can be reached, after the completion of a dis5 pute resolution process. 

6 ‘‘SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS. 

7 ‘‘(a) IN GENERAL.—All presubmissions and submis8 sions to the Food and Drug Administration with respect 

9 to an in vitro clinical test shall include an electronic copy 

10 of such presubmission or submission, and, with respect to 

11 the information required under sections 587B and 587D, 

12 shall utilize the system described in section 587T. 

13 ‘‘(b) ELECTRONIC FORMAT.—Beginning on such date 

14 as the Secretary specifies in final guidance issued under 

15 subsection (c), presubmissions and submissions for in vitro 

16 clinical tests (and any appeals of action taken by the Sec17 retary with respect to such presubmissions and submis18 sions) shall be submitted solely in such electronic format 

19 as specified by the Secretary in such guidance. 

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

21 implementing this section. In such guidance, the Secretary 

22 may— 

23 ‘‘(1) provide standards for the electronic copy 

24 required under subsection (a) or the submission in 

25 electronic format required under subsection (b); 


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1 ‘‘(2) set forth criteria for waivers of or exemp2 tions from the requirements of subsection (a) or (b); 

3 and 

4 ‘‘(3) provide any other information for the effi5 cient implementation and enforcement of this sec6 tion. 

7 ‘‘SEC. 587Z. POSTMARKET REMEDIES. 

8 ‘‘(a) SAFETY NOTICE.— 

9 ‘‘(1) IN GENERAL.—If the Secretary determines 

10 that an in vitro clinical test presents an unreason11 able risk of substantial harm to the public health, 

12 and notification under this subsection is necessary to 

13 eliminate the unreasonable risk of such harm and no 

14 more practicable means is available under the provi15 sions of this Act (other than this section) to elimi16 nate the risk, the Secretary may issue such order as 

17 may be necessary to ensure that adequate safety no18 tice is provided in an appropriate form, by the per19 sons and means best suited under the circumstances, 

20 to all health care professionals who prescribe, order, 

21 or use the in vitro clinical test and to any other per22 son (including developers, manufacturers, importers, 

23 distributors, retailers, and users) who should prop24 erly receive such notice. 


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1 ‘‘(2) NOTICE TO INDIVIDUALS.—An order 

2 under this subsection shall require that the individ3 uals subject to the risk with respect to which the 

4 order is to be issued be included in the persons to 

5 be notified of the risk unless the Secretary deter6 mines that notice to such individuals would present 

7 a greater danger to the health of such individuals 

8 than no such notice. If the Secretary makes such a 

9 determination with respect to such individuals, the 

10 order shall advise the health care professionals who 

11 prescribed, ordered, or used the in vitro clinical test 

12 provide notification to the individuals for whom the 

13 health professionals prescribed, ordered, or used 

14 such test, of the risk presented by such in vitro clin15 ical test and of any action which may be taken by 

16 or on behalf of such individuals to eliminate or re17 duce such risk. Before issuing an order under this 

18 subsection, the Secretary shall consult with the per19 sons required to give notice under the order. 

20 ‘‘(b) REPAIR, REPLACEMENT, OR REFUND.— 

21 ‘‘(1) DETERMINATION AFTER AN INFORMAL

22 HEARING.— 

23 ‘‘(A) IN GENERAL.—If, after affording op24 portunity for an informal hearing, the Secretary 

25 determines that— 


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1 ‘‘(i) an in vitro clinical test presents 

2 an unreasonable risk of substantial harm 

3 to the public health; 

4 ‘‘(ii) there are reasonable grounds to 

5 believe that the in vitro clinical test was 

6 not properly developed or manufactured 

7 considering the state of the art as it ex8 isted at the time of its development or 

9 manufacture; 

10 ‘‘(iii) there are reasonable grounds to 

11 believe that the unreasonable risk was not 

12 caused by failure of a person other than a 

13 developer, manufacturer, importer, dis14 tributor, or retailer of the in vitro clinical 

15 test to exercise due care in the installation, 

16 maintenance, repair, or use of the in vitro 

17 clinical test; and 

18 ‘‘(iv) the notice authorized by sub19 section (a) would not by itself be sufficient 

20 to eliminate the unreasonable risk and ac21 tion described in paragraph (2) of this sub22 section is necessary to eliminate such risk, 

23 the Secretary may order the developer, manu24 facturer, importer, or any distributor of such in 

25 vitro clinical test, or any combination of such 


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1 persons, to submit to him within a reasonable 

2 time a plan for taking one or more of the ac3 tions described in paragraph (2). An order 

4 issued under the preceding sentence which is di5 rected to more than one person shall specify 

6 which person may decide which action shall be 

7 taken under such plan and the person specified 

8 shall be the person who the Secretary deter9 mines bears the principal, ultimate financial re10 sponsibility for action taken under the plan un11 less the Secretary cannot determine who bears 

12 such responsibility or the Secretary determines 

13 that the protection of the public health requires 

14 that such decision be made by a person (includ15 ing a health professional or user of the in vitro 

16 clinical test) other than the person the Sec17 retary determines bears such responsibility. 

18 ‘‘(B) SECRETARY APPROVAL OF PLAN.— 

19 Within 30 calendar days of issuing an order 

20 under subparagraph (A), the Secretary shall ap21 prove a plan submitted pursuant to an order 

22 issued under subparagraph (A) unless the Sec23 retary determines (after affording opportunity 

24 for an informal hearing) that the action or ac25 tions to be taken under the plan or the manner 


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1 in which such action or actions are to be taken 

2 under the plan will not assure that the unrea3 sonable risk with respect to which such order 

4 was issued will be eliminated. If the Secretary 

5 disapproves a plan, the Secretary shall order a 

6 revised plan to be submitted within a reason7 able time. If the Secretary determines (after af8 fording opportunity for an informal hearing) 

9 that the revised plan is unsatisfactory or if no 

10 revised plan or no initial plan has been sub11 mitted to the Secretary within the prescribed 

12 time, the Secretary shall (i) prescribe a plan to 

13 be carried out by the person or persons to 

14 whom the order issued under subparagraph (A) 

15 was directed, or (ii) after affording an oppor16 tunity for an informal hearing, by order pre17 scribe a plan to be carried out by a person who 

18 is a manufacturer, importer, distributor, or re19 tailer of the in vitro clinical test with respect to 

20 which the order was issued but to whom the 

21 order under subparagraph (A) was not directed. 

22 ‘‘(2) ACTIONS ON A PLAN.—The actions which 

23 may be taken under a plan submitted under an 

24 order issued under paragraph (1) are as follows: 


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1 ‘‘(A) To repair the in vitro clinical test so 

2 that it does not present the unreasonable risk 

3 of substantial harm with respect to which the 

4 order under paragraph (1)(A) was issued. 

5 ‘‘(B) To replace the in vitro clinical test 

6 with a like or equivalent test which is in con7 formity with all applicable requirements of this 

8 Act. 

9 ‘‘(C) To refund the purchase price of the 

10 in vitro clinical test (less a reasonable allowance 

11 for use if such in vitro clinical test has been in 

12 the possession of the user for one year or more 

13 at the time of notice ordered under subsection 

14 (a), or at the time the user receives actual no15 tice of the unreasonable risk with respect to 

16 which the order was issued under paragraph 

17 (1)(A), whichever occurs first). 

18 ‘‘(3) NO CHARGE.—No charge shall be made to 

19 any person (other than a developer, manufacturer, 

20 importer, distributor or retailer) for using a remedy 

21 described in paragraph (2) and provided under an 

22 order issued under paragraph (1), and the person 

23 subject to the order shall reimburse each person 

24 (other than a developer, manufacturer, importer, 

25 distributor, or retailer) who is entitled to such a 


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1 remedy for any reasonable and foreseeable expenses 

2 actually incurred by such person in availing himself 

3 of such remedy. 

4 ‘‘(c) REIMBURSEMENT.—An order issued under sub5 section (b)(1)(A) with respect to an in vitro clinical test 

6 may require any person who is a developer, manufacturer, 

7 importer, distributor, or retailer of the in vitro clinical test 

8 to reimburse any other person who is a developer, manu9 facturer, importer, distributor, or retailer of such in vitro 

10 clinical test for such other person’s expenses actually in11 curred in connection with carrying out the order if the 

12 Secretary determines such reimbursement is required for 

13 the protection of the public health. Any such requirement 

14 shall not affect any rights or obligations under any con15 tract to which the person receiving reimbursement or the 

16 person making such reimbursement is a party. 

17 ‘‘(d) RECALL AUTHORITY.— 

18 ‘‘(1) IN GENERAL.—If the Secretary finds that 

19 there is a reasonable probability that an in vitro 

20 clinical test approved under section 587B would 

21 cause serious, adverse health consequences or death, 

22 including by the absence, delay, or discontinuation of 

23 appropriate medical treatment, the Secretary shall 

24 issue an order requiring the appropriate person (in25 cluding the developers, manufacturers, importers, 


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1 distributors, or retailers of the in vitro clinical 

2 test)— 

3 ‘‘(A) to immediately cease distribution of 

4 such in vitro clinical test; and 

5 ‘‘(B) to immediately notify health profes6 sionals and user facilities of the order and to 

7 instruct such professionals and facilities to 

8 cease use of such in vitro clinical test. 

9 ‘‘(2) INFORMAL HEARING.—The order issued 

10 under paragraph (1)(A), shall provide the person 

11 subject to the order with an opportunity for an in12 formal hearing, to be held not later than 10 calendar 

13 days after the date of the issuance of the order, on 

14 the actions required by the order and on whether the 

15 order should be amended to require a recall of such 

16 in vitro clinical test. If, after providing an oppor17 tunity for such a hearing, the Secretary determines 

18 that inadequate grounds exist to support the actions 

19 required by the order, the Secretary shall vacate the 

20 order. 

21 ‘‘(3) AMENDED ORDER.— 

22 ‘‘(A) IN GENERAL.—If, after providing an 

23 opportunity for an informal hearing under 

24 paragraph (2), the Secretary determines that 

25 the order should be amended to include a recall 


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1 of the in vitro clinical test with respect to which 

2 the order was issued, the Secretary shall, except 

3 as provided in subparagraph (B), amend the 

4 order to require a recall. The Secretary shall 

5 specify a timetable in which the recall will occur 

6 and shall require periodic reports describing the 

7 progress of the recall. 

8 ‘‘(B) REQUIREMENTS.—An amended order 

9 under subparagraph (A)— 

10 ‘‘(i) shall not include recall of the in 

11 vitro clinical test from individuals; 

12 ‘‘(ii) shall not include recall of an in 

13 vitro clinical test from test user facilities if 

14 the Secretary determines that the risk of 

15 recalling such in vitro clinical test from the 

16 facilities presents a greater health risk 

17 than the health risk of not recalling the in 

18 vitro clinical test from use; and 

19 ‘‘(iii) shall provide for notice to indi20 viduals subject to the risks associated with 

21 the use of such in vitro clinical test. In 

22 providing the notice required by this 

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1 scribed, ordered, or used such an in vitro 

2 clinical test for individuals. 

3 ‘‘(4) CLARIFICATION.—The remedy provided by 

4 this subsection shall be in addition to remedies pro5 vided by subsections (b) and (c).’’. 

6 SEC. 4. ENFORCEMENT AND OTHER PROVISIONS. 

7 (a) PROHIBITED ACTS.—Section 301 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend9 ed— 

10 (1) in paragraphs (a), (b), (c), (g), (k), (q), (r), 

11 and (y), by inserting ‘‘in vitro clinical test,’’ after 

12 ‘‘device,’’ each place it appears; 

13 (2) in paragraph (y) by inserting ‘‘or 587P’’ 

14 after ‘‘section 523’’ each place it appears; and 

15 (3) by adding at the end, the following: 

16 ‘‘(fff)(1) The introduction or delivery for introduction 

17 into interstate commerce of an in vitro clinical test in vio18 lation of section 587B(a). 

19 ‘‘(2) The false, fraudulent, or deceptive claiming for 

20 an in vitro clinical test of an exemption from the pre21 market review required under section 587B. 

22 ‘‘(3) When claiming an exemption under section 

23 587A from the premarket review required under section 

24 587B, the failure to maintain complete and accurate docu25 mentation for the exemption as required under section 


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1 587A or the failure to provide labeling required under sec2 tion 587A. 

3 ‘‘(4) With respect to an in vitro clinical test, the sub4 mission of any report that is required by or under this 

5 Act that is false or misleading in any material respect. 

6 ‘‘(5) The making of a false, fraudulent, or materially 

7 deceptive analytical or clinical claim for an in vitro clinical 

8 test— 

9 ‘‘(A) in any application, report, or notification 

10 submitted to the Secretary under this Act; or 

11 ‘‘(B) in the labeling or advertising of an in vitro 

12 clinical test. 

13 ‘‘(6) The failure to comply with a condition of ap14 proval, performance standard, mitigating measure, or re15 striction established in an order approving an application 

16 or supplement under section 587B; the failure to perform 

17 a risk analysis required by section 587B; the failure to 

18 submit an annual report required under section 587B(k); 

19 or the failure to complete postmarket studies required 

20 under section 587V. 

21 ‘‘(7) The marketing of an in vitro clinical test in vio22 lation of— 

23 ‘‘(A) an order issued by the Secretary under 

24 section 587A; or 

25 ‘‘(B) any requirement under section 587A. 


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1 ‘‘(8) With respect to technology certification under 

2 section 587D, the refusal to permit, or unreasonable delay 

3 in permitting, an inspection authorized under section 

4 587D(f)(3)(G); the failure to comply with applicable re5 quirements to submit an application or report under sec6 tion 587D(e); or the failure to comply with applicable 

7 maintenance requirements under section 587D(h). 

8 ‘‘(9) The failure to comply with an applicable miti9 gating measure established under section 587E or to 

10 maintain the documentation required under section 

11 587E(b); or the failure to comply with a performance 

12 standard established under section 587Q. 

13 ‘‘(10) The failure to register in accordance with sec14 tion 587I, the failure to provide information required 

15 under section 587I(b), or the failure to maintain or submit 

16 information required under section 587I(c). 

17 ‘‘(11) The failure to submit a report required under 

18 section 587L or 587M; the failure to comply with a re19 striction imposed under section 587N; or the failure to 

20 comply with labeling and advertising requirements under 

21 section 587N(b). 

22 ‘‘(12) The failure to comply with the requirements 

23 of section 587P (relating to accredited persons). 

24 ‘‘(13) The failure to comply with any requirement 

25 prescribed or established under section 587R; the failure 


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1 to furnish any notification, information, material, or re2 port required under section 587R; or the failure to comply 

3 with an order issued under section 587R.’’. 

4 (b) PENALTIES.—Section 303(f)(1) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)) is 

6 amended— 

7 (1) in subparagraph (A), by inserting ‘‘or in 

8 vitro clinical tests’’ after ‘‘devices’’; and 

9 (2) in subparagraph (B)(i)— 

10 (A) by inserting ‘‘, or 587J or 587L,’’ 

11 after ‘‘520(f)’’; and 

12 (B) by inserting ‘‘, or who violates section 

13 587M(b) with respect to a correction report’’ 

14 after ‘‘risk to public health’’. 

15 (c) SEIZURE.—Section 304 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 334) is amended— 

17 (1) in subsection (a)(2)— 

18 (A) by striking ‘‘and’’ before ‘‘(E) Any’’; 

19 and 

20 (B) by inserting ‘‘, and (F) Any adulter21 ated or misbranded in vitro clinical test’’ after 

22 ‘‘tobacco product’’; 

23 (2) in subsection (d)(1), by inserting ‘‘in vitro 

24 clinical test,’’ after ‘‘device,’’; and 

25 (3) in subsection (g)— 


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1 (A) in paragraph (1), by inserting ‘‘, in 

2 vitro clinical test,’’ after ‘‘device’’ each place it 

3 appears; and 

4 (B) in paragraph (2)— 

5 (i) in subparagraph (A), by inserting 

6 ‘‘, in vitro clinical test,’’ after ‘‘device’’; 

7 and 

8 (ii) in subparagraph (B), by inserting 

9 ‘‘or in vitro clinical test’’ after ‘‘device’’ 

10 each place it appears. 

11 (d) DEBARMENT, TEMPORARY DENIAL OF AP12 PROVAL, AND SUSPENSION.—Section 306 of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is 

14 amended by adding at the end the following: 

15 ‘‘(n) IN VITRO CLINICAL TESTS; MANDATORY DE16 BARMENT REGARDING THIRD-PARTY INSPECTIONS AND

17 REVIEWS.— 

18 ‘‘(1) IN GENERAL.—If the Secretary finds that 

19 a person has been convicted of a felony under sec20 tion 301(gg), 301(fff)(2), 301(fff)(5), or 301(fff)(8), 

21 the Secretary shall debar such person from being ac22 credited under section 587P and from carrying out 

23 activities under an agreement described in section 

24 803(b). 


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1 ‘‘(2) DEBARMENT PERIOD.—The Secretary 

2 shall debar a person under paragraph (1) for the fol3 lowing periods: 

4 ‘‘(A) The period of debarment of a person 

5 (other than an individual) shall not be less than 

6 1 year or more than 10 years, but if an act 

7 leading to a subsequent debarment under such 

8 paragraph occurs within 10 years after such 

9 person has been debarred under such para10 graph, the period of debarment shall be perma11 nent. 

12 ‘‘(B) The debarment of an individual shall 

13 be permanent. 

14 ‘‘(3) TERMINATION OF DEBARMENT; JUDICIAL

15 REVIEW; OTHER MATTERS.—Subsections (c)(3), (d), 

16 (e), (i), (j), and (l)(1) apply with respect to a person 

17 (other than an individual) or an individual who is 

18 debarred under paragraph (1) to the same extent 

19 and in the same manner as such subsections apply 

20 with respect to a person who is debarred under sub21 section (a)(1), or an individual who is debarred 

22 under subsection (a)(2), respectively.’’. 

23 (e) JUDICIAL REVIEW.—Section 517(a) of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)) 

25 is amended— 


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1 (1) in paragraph (8), by striking ‘‘or’’ at the 

2 end; 

3 (2) in paragraph (9), by inserting ‘‘or’’ after 

4 the comma at the end; and 

5 (3) before the matter that follows paragraph 

6 (9), by inserting the following: 

7 ‘‘(10) an order issued pursuant to section 

8 587B, 587D, 587R, or 587S,’’. 

9 (f) EXPANDED ACCESS TO UNAPPROVED THERAPIES

10 AND DIAGNOSTICS.—Section 561 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 360bbb) is amend12 ed— 

13 (1) in subsections (a) through (d)— 

14 (A) by striking ‘‘or investigational devices’’ 

15 each place it appears and inserting ‘‘, investiga16 tional devices, or investigational in vitro clinical 

17 tests’’; and 

18 (B) by striking ‘‘or investigational device’’ 

19 each place it appears (other than the second 

20 such place in paragraph (3)(A)) and inserting 

21 ‘‘, investigational device, or investigational in 

22 vitro clinical test’’; 

23 (2) in subsection (b)(4) by striking ‘‘or 520(g)’’ 

24 and inserting ‘‘, 520(g), or 587R’’ each place it ap25 pears; 


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1 (3) in subsection (c)— 

2 (A) by amending the subsection heading to 

3 read: ‘‘TREATMENT INVESTIGATIONAL NEW

4 DRUG APPLICATIONS, TREATMENT INVESTIGA5 TIONAL DEVICE EXEMPTIONS, AND TREAT6 MENT INVESTIGATIONAL IN VITRO CLINICAL

7 TEST EXEMPTIONS’’; 

8 (B) in paragraph (3)(A), by striking ‘‘or 

9 investigational device exemption in effect under 

10 section 520(g)’’ and inserting ‘‘, investigational 

11 device exemption in effect under section 520(g), 

12 or investigational in vitro clinical test exemption 

13 under section 587R’’; 

14 (C) by striking ‘‘or treatment investiga15 tional device exemption’’ each place it appears 

16 and inserting ‘‘, treatment investigational device 

17 exemption, or treatment investigational in vitro 

18 clinical test exemption’’; and 

19 (D) in the matter following paragraph (7) 

20 by striking ‘‘or 520(g)’’ each place it appears 

21 and inserting ‘‘, 520(g) or 587R’’; and 

22 (4) by amending subsection (e) to read as fol23 lows: 

24 ‘‘(e) DEFINITIONS.—In this section, the terms ‘inves25 tigational drug’, ‘investigational device’, ‘investigational in 


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1 vitro clinical test’, ‘treatment investigational new drug ap2 plication’, ‘treatment investigational device exemption’, 

3 and ‘treatment investigational in vitro clinical test exemp4 tion’ shall have the meanings given the terms in regula5 tions prescribed by the Secretary.’’. 

6 (g) OPTIMIZING GLOBAL CLINICAL TRIALS.—Section 

7 569A(b) of the Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 360bbb–8a(b)) is amended by inserting ‘‘an in 

9 vitro clinical test, as defined in subsection (ss) of such sec10 tion,’’ before ‘‘or a biological product’’. 

11 (h) PATIENT PARTICIPATION IN MEDICAL PRODUCT

12 DISCUSSION.—The heading of subsection (a) of section 

13 569C of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 360bbb–8c) is amended by striking ‘‘DRUGS AND

15 DEVICES’’ and inserting ‘‘DRUGS, DEVICES, AND IN

16 VITRO CLINICAL TESTS’’. 

17 (i) REGULATIONS AND HEARINGS.—Section 

18 701(h)(1)(C)(ii) of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 371(h)(1)(C)(ii)) is amended by inserting 

20 ‘‘and in vitro clinical tests’’ after ‘‘devices’’. 

21 (j) FACTORY INSPECTION.—Section 704 of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) (other 

23 than subsection (g)) is amended— 


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1 (1) by striking ‘‘drugs or devices’’ each place it 

2 appears and inserting ‘‘drugs, devices, or in vitro 

3 clinical tests’’; 

4 (2) in subsection (a)(1), in the third sentence, 

5 by striking ‘‘or chapter IX’’ and inserting ‘‘section 

6 587R or chapter IX’’; 

7 (3) in subsection (a)(2)(B)— 

8 (A) by inserting ‘‘or in vitro clinical tests’’ 

9 after ‘‘prescribe or use devices’’; and 

10 (B) by inserting ‘‘or in vitro clinical tests’’ 

11 after ‘‘process devices’’; 

12 (4) by inserting ‘‘in vitro clinical test,’’ after 

13 ‘‘device,’’ each place it appears; 

14 (5) after making the amendments in para15 graphs (1) and (2), by inserting ‘‘in vitro clinical 

16 tests,’’ after ‘‘devices,’’ each place it appears; 

17 (6) in subsection (e), by inserting ‘‘, or section 

18 587L, 587M, or 587R,’’ after ‘‘section 519 or 

19 520(g)’’; and 

20 (7) in subsection (f)(3)— 

21 (A) in subparagraph (A), by striking ‘‘or’’ 

22 at the end; 

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

24 period at the end and inserting ‘‘; or’’; and 


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1 (C) after subparagraph (B), by inserting 

2 the following: 

3 ‘‘(C) is accredited under section 587P.’’. 

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) IMPORTS AND EXPORTS.—Section 801 of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 

12 is amended— 

13 (1) in subsection (a)— 

14 (A) by inserting ‘‘in vitro clinical tests,’’ 

15 after ‘‘devices,’’ each place it appears; and 

16 (B) by inserting ‘‘in the case of an in vitro 

17 clinical test, the test does not conform to the 

18 applicable requirements of section 587J, or’’ 

19 after ‘‘requirements of section 520(f), or’’; 

20 (2) in subsection (d)(3)— 

21 (A) in subparagraph (A)— 

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

23 by inserting ‘‘and no component of an in 

24 vitro clinical test or other article of in vitro 


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1 clinical test that requires further proc2 essing,’’ after ‘‘health-related purposes’’; 

3 (ii) in clause (i), by striking ‘‘drug or 

4 device’’ and inserting ‘‘drug, device, or in 

5 vitro clinical test’’; and 

6 (iii) in clause (i)(I), by inserting ‘‘in 

7 vitro clinical test,’’ after ‘‘device,’’; and 

8 (B) in subparagraph (B), by inserting ‘‘in 

9 vitro clinical test,’’ after ‘‘device,’’; and 

10 (3) in subsection (e)(1), by inserting ‘‘in vitro 

11 clinical test,’’ after ‘‘device,’’. 

12 (n) OFFICE OF INTERNATIONAL RELATIONS.—Sec13 tion 803 of the Federal Food, Drug, and Cosmetic Act 

14 (21 U.S.C. 383) is amended— 

15 (1) in subsection (b)— 

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

17 by inserting ‘‘and in vitro clinical tests’’ after 

18 ‘‘devices’’; and 

19 (B) in paragraph (1), by inserting ‘‘quality 

20 requirements established under section 587J; 

21 and’’ at the end; and 

22 (2) in subsection (c)— 

23 (A) in paragraph (2), by inserting ‘‘in vitro 

24 clinical tests,’’ after ‘‘devices,’’; and 


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1 (B) in paragraph (4), by inserting ‘‘or in 

2 vitro clinical tests’’ after ‘‘devices’’. 

3 (o) RECOGNITION OF FOREIGN GOVERNMENT IN4 SPECTIONS.—Section 809(a)(1) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amend6 ed by inserting ‘‘, or section 587I’’ after ‘‘510(h)’’. 

7 (p) FOOD AND DRUG ADMINISTRATION.—Section 

8 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 393(b)(2)) is amended— 

10 (1) in subparagraph (D), by striking ‘‘and’’ at 

11 the end; 

12 (2) in subparagraph (E), by striking the semi13 colon at the end and inserting ‘‘; and’’; and 

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

15 ‘‘(F) in vitro clinical tests are analytically 

16 and clinically valid;’’. 

17 (q) OFFICE OF WOMEN’S HEALTH.—Section 1011(b) 

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

19 399b(b)) is amended— 

20 (1) in paragraph (1), by inserting ‘‘in vitro clin21 ical tests,’’ after ‘‘devices,’’; and 

22 (2) in paragraph (4), by striking ‘‘and device 

23 manufacturers’’ and inserting ‘‘device manufactur24 ers, and in vitro clinical test developers,’’. 


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1 (r) COUNTERMEASURE PROVISIONS OF THE

2 PHSA.—Title III of the PHSA is amended— 

3 (1) in section 319F–2(c)(1)(B) (42 U.S.C. 

4 247d–6b(c)(1)(B)) is amended— 

5 (A) by striking ‘‘or device’’ and inserting 

6 ‘‘device’’; and 

7 (B) by inserting ‘‘or an in vitro clinical 

8 test (as that term is defined in section 201(ss) 

9 of the Federal Food, Drug, and Cosmetic Act 

10 (21 U.S.C. 321(ss)))’’ after ‘‘Act (21 U.S.C. 

11 321(h)))’’; 

12 (2) in section 319F–1(a)(2) (42 U.S.C. 247d– 

13 6a(a)(2)), by inserting ‘‘an in vitro clinical tests (as 

14 that term is defined in section 201(ss) of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

16 321(ss))),’’ before ‘‘or device’’; and 

17 (3) in section 319F–3(i)(7) (42 U.S.C. 247d– 

18 6d(i)(7)), by inserting ‘‘an in vitro clinical tests (as 

19 that term is defined in section 201(ss) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 321(ss))),’’ before ‘‘or device’’. 

22 SEC. 5. TRANSITION. 

23 (a) IMPLEMENTATION.— 

24 (1) EFFECTIVE DATE.— 


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1 (A) IN GENERAL.—Except as otherwise 

2 provided in this section, the amendments made 

3 by this Act apply 4 years after the date of en4 actment of this Act (in this section and in sub5 chapter J of chapter V of the Federal Food, 

6 Drug, and Cosmetic Act, as added by this Act, 

7 referred to in this section as the ‘‘effective date 

8 of this Act’’). 

9 (B) EXCEPTION.—The Secretary of Health 

10 and Human Services (in this section referred to 

11 as the ‘‘Secretary’’) may take the actions de12 scribed in paragraph (2), and may expend such 

13 funds as the Secretary determines necessary to 

14 ensure an orderly transition. 

15 (2) ACTIONS.—The Secretary shall, prior to the 

16 date on which the amendments made by this Act 

17 generally apply pursuant to paragraph (1)— 

18 (A) within 1 year of the date of enactment 

19 of this Act hold the public meetings described 

20 in subchapter J of chapter V of the Federal 

21 Food, Drug, and Cosmetic Act, as added by 

22 section 3; 

23 (B) within 2 years of the date of enact24 ment of this Act promulgate final regulations 


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1 required under sections 587B, 587D, 587L, 

2 587M, 587V, and 587W; and 

3 (C) within 2 years of the date of enact4 ment of this Act issue final guidance on appli5 cability requirements under section 587A. 

6 (3) APPLICABILITY OF REGULATIONS.—Not7 withstanding the date on which guidance or regula8 tions are issued under paragraph (2), no guidance or 

9 regulations issued pursuant to the amendments 

10 made by this Act shall take effect until the effective 

11 date of this Act, as described in paragraph (1), ex12 cept as otherwise provided for transitional tests 

13 under this section. 

14 (b) APPLICATION OF AUTHORITIES TO IN VITRO

15 CLINICAL TESTS UNTIL AND AFTER EFFECTIVE DATE

16 OF THIS ACT.—Except as provided in subsections (c) and 

17 (d), for any in vitro clinical test as defined in section 

18 201(ss) of the Federal Food, Drug, and Cosmetic Act, as 

19 added by this Act, the following authorities shall apply: 

20 (1) TESTS OFFERED PRIOR TO ENACTMENT.— 

21 An in vitro clinical test that meets the criteria for 

22 a grandfathered test as set forth in section 

23 587A(c)(2) of the Federal Food, Drug, and Cos24 metic Act, as added by section 3, may continue to 

25 be offered for clinical use and shall be subject only 


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1 to applicable provisions of section 353 of the Public 

2 Health Service Act and section 587A(a)(4) of the 

3 Federal Food, Drug, and Cosmetic Act, as added by 

4 section 3. 

5 (2) TESTS APPROVED OR CLEARED ON OR

6 AFTER THE DATE OF ENACTMENT BUT PRIOR TO

7 THE EFFECTIVE DATE.—Before any in vitro clinical 

8 test as defined in section 201(ss) of the Federal 

9 Food, Drug, and Cosmetic Act, as added by this 

10 Act, is first offered, sold, or distributed after the 

11 date of enactment of this Act, but prior to the effec12 tive date of this Act, such product or test shall be 

13 considered a transitional test as described under 

14 subsection (c) and comply with the applicable device 

15 provisions of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 301 et seq.) and the Public Health 

17 Service Act (42 U.S.C. 201 et seq.). 

18 (3) TESTS UNDER FDA REVIEW BEGINNING ON

19 OR AFTER THE DATE OF ENACTMENT OF THIS ACT

20 BUT PRIOR TO IMPLEMENTATION.—For any in vitro 

21 clinical test as defined in section 201(ss) of the Fed22 eral Food, Drug, and Cosmetic Act, as added by this 

23 Act, for which a submission for marketing authoriza24 tion under section 515, clearance under section 

25 510(k), authorization under section 513(f)(2), apVerDate Sep 11 2014 01:53 Jul 08, 2021 Jkt 019200 PO 00000 Frm 00211 Fmt 6652 Sfmt 6201 E:\BILLS\S2209.IS S2209

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1 proval under section 520(m), or emergency use au2 thorization under section 564 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 360e, 360(k), 

4 360c(f)(2), 360j(m), 360bbb–3) or approval under 

5 the Public Health Service Act (42 U.S.C. 201 et 

6 seq.) is pending on the effective date of this Act, the 

7 Secretary may review and take action on such sub8 mission after the effective date of this Act according 

9 to the statutory provision under which such submis10 sion was submitted. 

11 (c) APPLICATION OF AUTHORITIES TO TRANSI12 TIONAL AND GRANDFATHERED IN VITRO CLINICAL

13 TESTS.— 

14 (1) DEFINITION.—For purposes of this section, 

15 the term ‘‘transitional in vitro clinical test’’ means 

16 an in vitro clinical test, as defined in section 201(ss) 

17 of the Federal Food, Drug, and Cosmetic Act, as 

18 added by this Act, that— 

19 (A) is offered for clinical use during the 

20 period beginning on the date of enactment of 

21 this Act and ending on the date that is 90 days 

22 after the effective 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 for use only within that 

3 certified laboratory or another laboratory within 

4 the organization under common ownership; and 

5 (C) is not approved under section 515, 

6 cleared under section 510(k), authorized under 

7 section 513(f)(2), subject to an exemption 

8 under section 520(m), or authorized under sec9 tion 564 of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 360e, 360(k), 360c(f)(2), 

11 360j(m), 360bbb–3) or approval under the Pub12 lic Health Service Act (42 U.S.C. 201 et seq.). 

13 (2) PREMARKET REVIEW OR TECHNOLOGY CER14 TIFICATION.—A transitional in vitro clinical test 

15 that is the subject of an application for premarket 

16 review under section 587B of the Federal Food, 

17 Drug, and Cosmetic Act or technology certification 

18 application under section 587D of such Act, as 

19 added by this Act, that is submitted prior to the ef20 fective date of this Act may continue to be offered, 

21 sold, or distributed until completion of the Sec22 retary’s review of the premarket application or tech23 nology certification application. 

24 (d) CONVERSION.— 


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1 (1) DEEMED PREMARKET APPROVAL.—Any in 

2 vitro clinical test (as defined in section 201(ss) of 

3 the Federal Food, Drug, and Cosmetic Act, as 

4 added by this Act) with a premarket approval under 

5 section 515, a clearance under section 510(k), an 

6 authorization under section 513(f), or a licensure 

7 under section 351 of the Public Health Service Act 

8 (42 U.S.C. 262) is deemed to have an approved ap9 plication under section 587B of the Federal Food, 

10 Drug, and Cosmetic Act, as added by this Act, be11 ginning on the later of— 

12 (A) the effective date of this Act; or 

13 (B) such other date, not later than 3 years 

14 after such effective date, as the person respon15 sible for the device selects. 

16 (2) DEEMED INVESTIGATIONAL USE AP17 PROVAL.—Any in vitro clinical test (as defined in 

18 section 201(ss) of the Federal Food, Drug, and Cos19 metic Act, as added by this Act) that has an ap20 proved investigational device exemption under sec21 tion 520(g) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 360j(g)) is deemed to have an 

23 approved investigational use under section 587Q of 

24 such Act, as added by this Act, beginning on the ef25 fective date of this Act. 


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1 (e) INSTRUMENTS.—An instrument (as defined in 

2 section 587 of the Federal Food, Drug, and Cosmetic Act, 

3 as added by this Act) that was purchased prior to the date 

4 of enactment of this Act and was not cleared, authorized, 

5 or approved by the Food and Drug Administration or part 

6 of an instrument family that was cleared, authorized, or 

7 approved by the Food and Drug Administration at the 

8 time of purchase may continue to be used by the purchaser 

9 to develop and introduce into interstate commerce an in 

10 vitro clinical test during the period beginning on the date 

11 of enactment of this Act and ending 5 years after such 

12 date of enactment. Beginning at the end of such period, 

13 any new in vitro clinical test that is developed and intro14 duced into interstate commerce shall be based on an in15 strument (as defined in section 587(11) of the Federal 

16 Food, Drug, and Cosmetic Act, as added by section 3) 

17 that complies with the requirements of the Federal Food, 

18 Drug, and Cosmetic Act, as amended by this Act. 

19 (f) RELATION TO IN VITRO CLINICAL TEST PROVI20 SION.—This section applies notwithstanding section 

21 587A(a)(1)(C) of the Federal Food, Drug, and Cosmetic 

22 Act, as added by this Act. 

23 SEC. 6. EMERGENCY USE AUTHORIZATION. 

24 Section 564 of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 360bbb–3) is amended— 


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1 (1) in paragraphs (1) and (4)(C) of subsection 

2 (a), by inserting ‘‘in vitro clinical test,’’ before ‘‘or 

3 biological product’’ each place such term appears; 

4 and 

5 (2) in subsection (e)(3)— 

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

7 ‘‘and’’ at the end; 

8 (B) in subparagraph (C), by striking the 

9 period and inserting ‘‘; and’’; and 

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

11 ‘‘(D) quality system requirements (with re12 spect to in vitro clinical tests) under section 

13 587J.’’. 

14 SEC. 7. ANTIMICROBIAL SUSCEPTIBILITY TESTS. 

15 Section 511A of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 360a–2) is amended— 

17 (1) in subsection (a)(1)(C)— 

18 (A) by striking ‘‘or approve under section 

19 515’’ and inserting ‘‘approve under section 515, 

20 or approve, exempt, or issue a technology cer21 tification order under subchapter J’’; and 

22 (B) by striking ‘‘testing devices’’ and in23 serting ‘‘tests’’; 


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1 (2) in subsection (c)(5), by striking ‘‘drug or 

2 device’’ each place it appears and inserting ‘‘drug, 

3 device, or in vitro clinical test’’; 

4 (3) in subsection (e)— 

5 (A) in the heading, by striking ‘‘TESTING

6 DEVICES’’ and inserting ‘‘IN VITRO CLINICAL

7 TESTS’’; 

8 (B) in paragraph (1)— 

9 (i) by striking ‘‘and 515,’’ and insert10 ing ‘‘515, 587B, and 587D’’; 

11 (ii) by striking ‘‘antimicrobial suscep12 tibility testing device’’ and inserting ‘‘anti13 microbial susceptibility in vitro clinical 

14 test’’; and 

15 (iii) by striking ‘‘such device’’ and in16 serting ‘‘such test’’; 

17 (C) in paragraph (2)— 

18 (i) in the heading, by striking ‘‘TEST19 ING DEVICES’’ and inserting ‘‘IN VITRO

20 CLINICAL TESTS’’; and 

21 (ii) by amending subparagraph (C) to 

22 read as follows: 

23 ‘‘(C) The antimicrobial susceptibility in 

24 vitro clinical test meets all other requirements 

25 to be approved under section 587B or exempted 


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1 from premarket review under section 587D.’’; 

2 and 

3 (D) after making the amendments in sub4 paragraphs (B)(ii), (B)(iii), and (C)(ii), by 

5 striking ‘‘device’’ each place it appears and in6 serting ‘‘in vitro clinical test’’; 

7 (4) in subsection (f), by amending paragraph 

8 (1) to read as follows: 

9 ‘‘(1) The term ‘antimicrobial susceptibility in 

10 vitro clinical test’ means an in vitro clinical test that 

11 utilizes susceptibility test interpretive criteria to de12 termine and report the in vitro susceptibility of cer13 tain microorganisms to a drug (or drugs).’’; and 

14 (5) in subsection (g)(2)— 

15 (A) by amending the matter preceding sub16 paragraph (A) to read as follows: 

17 ‘‘(2) with respect to clearing under section 

18 510(k), classifying under section 513(f)(2), approv19 ing under section 515 or section 587B, or exempting 

20 from approval requirements under section 587D—’’; 

21 and 

22 (B) in subparagraph (A)— 

23 (i) by striking ‘‘device’’ and inserting 

24 ‘‘in vitro clinical test’’; and 


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1 (ii) by striking ‘‘antimicrobial suscep2 tibility testing device’’ and inserting ‘‘anti3 microbial susceptibility in vitro clinical 

4 test’’. 

5 SEC. 8. COMBINATION PRODUCTS. 

6 (a) IN GENERAL.—Section 503(g) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is 

8 amended— 

9 (1) in paragraph (1)— 

10 (A) in subparagraph (A)— 

11 (i) by inserting ‘‘(except for a com12 bination product constituted of a device 

13 and an in vitro clinical test)’’ after ‘‘agency 

14 center,’’; and 

15 (ii) by inserting ‘‘in vitro clinical 

16 test,’’ before ‘‘or biological product’’; and 

17 (B) in subparagraph (D)— 

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

19 by striking ‘‘. If the Secretary determines’’ 

20 and inserting ‘‘, except for a combination 

21 product constituted of a device and an in 

22 vitro clinical test. For other combination 

23 products, if the Secretary determines’’; and 

24 (ii) in clause (ii)— 


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1 (I) by inserting ‘‘or in vitro clin2 ical test’’ after ‘‘device’’; and 

3 (II) by inserting ‘‘and in vitro 

4 clinical tests’’ before ‘‘shall’’; 

5 (2) in paragraph (3), by striking ‘‘safety and 

6 effectiveness or substantial equivalence’’ and insert7 ing ‘‘safety and effectiveness, substantial equiva8 lence, or analytical validity and clinical validity’’ be9 fore ‘‘for the approved constituent part’’; 

10 (3) in paragraph (4)— 

11 (A) in subparagraph (A), by striking ‘‘or 

12 513(f)(2) (submitted in accordance with para13 graph (5))’’ and inserting ‘‘513(f)(2) (sub14 mitted in accordance with paragraph (5)), 

15 587B, or an exempt test under section 587A, as 

16 applicable’’; and 

17 (B) in subparagraph (B), by inserting ‘‘or 

18 587B’’ after ‘‘section 515’’; 

19 (4) in paragraph (5)(A), by striking ‘‘or 

20 510(k)’’ and inserting ‘‘, 510(k), or 587B’’; 

21 (5) in paragraph (7), by striking ‘‘or substan22 tial equivalence’’ and inserting ‘‘, substantial equiva23 lence, or analytical validity and clinical validity’’; 

24 (6) in paragraph (8), by adding at the end the 

25 following: 


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1 ‘‘(I) This paragraph shall not apply to a 

2 combination product constituted of a device and 

3 an in vitro clinical test.’’; and 

4 (7) in paragraph (9)— 

5 (A) in subparagraph (C)(i), by striking ‘‘or 

6 520(g)’’ and inserting ‘‘520(g), or 587B’’; and 

7 (B) in subparagraph (D), by striking ‘‘or 

8 520’’ and inserting ‘‘520, or 587B’’. 

9 (b) CLASSIFICATION OF PRODUCTS.—Section 563 of 

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

11 360bbb–2) is amended by adding at the end the following: 

12 ‘‘(d) EXEMPTION.—This section shall not apply to a 

13 combination product constituted of a device and an in 

14 vitro clinical test.’’. 

15 SEC. 9. RESOURCES. 

16 (a) FINDINGS.—Congress finds that the fees author17 ized by this section will be dedicated to meeting the goals 

18 identified in the letters from the Secretary of Health and 

19 Human Services to the Committee on Health, Education, 

20 Labor, and Pensions of the Senate and the Committee on 

21 Energy and Commerce of the House of Representatives, 

22 as set forth in the Congressional Record. 

23 (b) ESTABLISHMENT OF USER FEE PROGRAM.— 

24 (1) DEVELOPMENT OF USER FEES FOR IN

25 VITRO CLINICAL TESTS.— 


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1 (A) IN GENERAL.—Beginning not later 

2 than October 1, 2021, the Secretary of Health 

3 and Human Services (in this section referred to 

4 as the ‘‘Secretary’’) shall develop recommenda5 tions to present to Congress with respect to the 

6 goals, and plans for meeting the goals, for the 

7 process of the review of in vitro clinical test ap8 plications submitted under subchapter J of 

9 chapter V of the Federal Food, Drug, and Cos10 metic Act, as added by this Act, for the first 5 

11 fiscal years after fiscal year 2022. In developing 

12 such recommendations, the Secretary shall con13 sult with— 

14 (i) the Committee on Energy and 

15 Commerce of the House of Representa16 tives; 

17 (ii) the Committee on Health, Edu18 cation, Labor, and Pensions of the Senate; 

19 (iii) scientific and academic experts; 

20 (iv) health care professionals; 

21 (v) representatives of patient and con22 sumer advocacy groups; and 

23 (vi) the regulated industry. 

24 (B) PRIOR PUBLIC INPUT.—Prior to begin25 ning negotiations with the regulated industry 


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1 on the authorization of such subchapter J, the 

2 Secretary shall— 

3 (i) publish a notice in the Federal 

4 Register requesting public input on the au5 thorization of user fees; 

6 (ii) hold a public meeting at which the 

7 public may present its views on the author8 ization, including specific suggestions for 

9 the recommendations submitted under sub10 paragraph (E); 

11 (iii) provide a period of 30 days after 

12 the public meeting to obtain written com13 ments from the public suggesting changes 

14 to such subchapter J; and 

15 (iv) publish any comments received 

16 under clause (iii) on the website of the 

17 Food and Drug Administration. 

18 (C) PERIODIC CONSULTATION.—Not less 

19 frequently than once every month during nego20 tiations with the regulated industry, the Sec21 retary shall hold discussions with representa22 tives of patient and consumer advocacy groups 

23 to continue discussions of the authorization 

24 under such subchapter J and to solicit sugges25 tions to be included in the recommendations 


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1 transmitted to Congress under subparagraph 

2 (E). 

3 (D) PUBLIC REVIEW OF RECOMMENDA4 TIONS.—After negotiations with the regulated 

5 industry, the Secretary shall— 

6 (i) present the recommendations de7 veloped under subparagraph (A) to the 

8 Committee on Health, Education, Labor, 

9 and Pensions of the Senate and the Com10 mittee on Energy and Commerce of the 

11 House of Representatives; 

12 (ii) publish such recommendations in 

13 the Federal Register; 

14 (iii) provide for a period of 30 days 

15 for the public to provide written comments 

16 on such recommendations; 

17 (iv) hold a meeting at which the pub18 lic may present its views on such rec19 ommendations; and 

20 (v) after consideration of such public 

21 views and comments, revise such rec22 ommendations as necessary. 

23 (E) TRANSMITTAL OF RECOMMENDA24 TIONS.— 


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1 (i) IN GENERAL.—Not later than 

2 June 1, 2021, the Secretary shall transmit 

3 to Congress the revised recommendations 

4 under subparagraph (A), a summary of the 

5 views and comments received under such 

6 subparagraph, and any changes made to 

7 the recommendations in response to such 

8 views and comments. 

9 (ii) RECOMMENDATION REQUIRE10 MENTS.—The recommendations trans11 mitted under this subparagraph shall— 

12 (I) include the number of full13 time equivalent employees per fiscal 

14 year that are agreed to be hired to 

15 carry out the goals included in such 

16 recommendations for each year of the 

17 5-year period; 

18 (II) provide that the amount of 

19 operating reserve balance in the user 

20 fee program established under this 

21 section is not more than the equiva22 lent of 10 weeks of operating reserve; 

23 (III) require the development of 

24 a strategic plan for any surplus within 

25 the operating reserve account above 


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1 the 10-week operating reserve within 

2 2 years of the establishment of the 

3 program; 

4 (IV) include an operating reserve 

5 adjustment such that, if the Secretary 

6 has an operating reserve balance in 

7 excess of 10 weeks of such operating 

8 reserves, the Secretary shall decrease 

9 such fee revenue and fees to provide 

10 for not more than 10 weeks of such 

11 operating reserves; 

12 (V) if an adjustment is made as 

13 described in subclause (IV), provide 

14 the rationale for the amount of the 

15 decrease in fee revenue and fees shall 

16 be contained in the Federal Register; 

17 and 

18 (VI) provide that the fees as19 sessed and collected for the full-time 

20 equivalent employees at the Center for 

21 Devices and Radiological Health, with 

22 respect to which the majority of time 

23 reporting data indicates are dedicated 

24 to the review of in vitro clinical tests, 

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1 thorized to be collected and assessed 

2 under section 738 of the Federal 

3 Food, Drug, and Cosmetic Act (21 

4 U.S.C. 379j). 

5 (F) PUBLICATION OF RECOMMENDA6 TIONS.—The Secretary shall publish on the 

7 website of the Food and Drug Administration 

8 the revised recommendations under subpara9 graph (A), a summary of the views and com10 ments received under subparagraphs (B) 

11 through (D), and any changes made to the rec12 ommendations originally proposed by the Sec13 retary in response to such views and comments. 

14 (G) MINUTES OF NEGOTIATION MEET15 INGS.— 

16 (i) PUBLIC AVAILABILITY.—Before 

17 transmitting the recommendations devel18 oped under subparagraphs (A) through (F) 

19 to Congress, the Secretary shall make pub20 licly available, on the website of the Food 

21 and Drug Administration, minutes of all 

22 negotiation meetings conducted under this 

23 subsection between the Food and Drug Ad24 ministration and the regulated industry. 


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1 (ii) CONTENT.—The minutes de2 scribed under clause (i) shall summarize 

3 any substantive proposal made by any 

4 party to the negotiations, any significant 

5 controversies or differences of opinion dur6 ing the negotiations, and the resolution of 

7 any such controversy or difference of opin8 ion. 

9 (2) ESTABLISHMENT OF USER FEE PRO10 GRAM.—Effective on October 1, 2021, provided that 

11 the Secretary transmits the recommendations under 

12 paragraph (1)(E), the Secretary is authorized to col13 lect user fees relating to the submission of in vitro 

14 clinical test applications submitted under subchapter 

15 J of chapter V of the Federal Food, Drug, and Cos16 metic Act, as added by this Act. Fees under such 

17 program shall be assessed and collected only if the 

18 requirements under paragraph (4) are met. 

19 (3) AUDIT.— 

20 (A) IN GENERAL.—On the date that is 2 

21 years after first receiving a user fee applicable 

22 to submission of an in vitro clinical test applica23 tion submitted under subchapter J of chapter V 

24 of the Federal Food, Drug, and Cosmetic Act, 

25 as added by this Act, and on a biennial basis 


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1 thereafter until October 1, 2027, the Secretary 

2 shall perform an audit of the costs of reviewing 

3 such applications under such subchapter J. 

4 Such an audit shall compare the costs of re5 viewing such applications under such sub6 chapter J to the amount of the user fee applica7 ble to such applications. 

8 (B) ALTERATION OF USER FEE.—If the 

9 audit performed under subparagraph (A) indi10 cates that the user fees applicable to applica11 tions submitted under such subchapter J exceed 

12 30 percent of the costs of reviewing such appli13 cations, the Secretary shall alter the user fees 

14 applicable to applications submitted under such 

15 subchapter J such that the user fees do not ex16 ceed such percentage. 

17 (C) ACCOUNTING STANDARDS.—The Sec18 retary shall perform an audit under subpara19 graph (A) in conformance with the accounting 

20 principles, standards, and requirements pre21 scribed by the Comptroller General of the 

22 United States under section 3511 of title 31, 

23 United States Code, to ensure the validity of 

24 any potential variability. 


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1 (4) CONDITIONS.—The user fee program de2 scribed in this subsection shall take effect only if the 

3 Food and Drug Administration issues draft guidance 

4 related to the review requirements for in vitro diag5 nostic tests that would be subject to premarket re6 view under section 587B of the Federal Food, Drug, 

7 and Cosmetic Act, as added by section 3, the review 

8 requirements for test categories eligible for tech9 nology certification under section 587D of such Act, 

10 as added by section 3, and the parameters for the 

11 test categories that would be exempt from any re12 view under subchapter J of chapter V of such Act. 

13 (5) USER FEE PROGRAM DEFINITIONS AND RE14 SOURCE REQUIREMENTS.— 

15 (A) IN GENERAL.—The term ‘‘process for 

16 the review of in vitro clinical test applications’’ 

17 means the following activities of the Secretary 

18 with respect to the review of premarket applica19 tions under section 587B of the Federal Food, 

20 Drug, and Cosmetic Act (as added by section 

21 3), technology certification applications under 

22 section 587D of such Act (as added by section 

23 3), and supplements for such applications: 

24 (i) The activities necessary for the re25 view of premarket applications, premarket 


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1 reports, and supplements to such applica2 tions. 

3 (ii) The issuance of action letters that 

4 allow the marketing of in vitro clinical 

5 tests or which set forth in detail the spe6 cific deficiencies in such applications, re7 ports, supplements, or submissions and, 

8 where appropriate, the actions necessary to 

9 place them in condition for approval. 

10 (iii) The inspection of manufacturing 

11 establishments and other facilities under12 taken as part of the Secretary’s review of 

13 pending premarket applications, technology 

14 certifications, and supplements. 

15 (iv) Monitoring of research conducted 

16 in connection with the review of such appli17 cations, supplements, and submissions. 

18 (v) Review of in vitro clinical test ap19 plications subject to section 351 of the 

20 Public Health Service Act (42 U.S.C. 

21 262), investigational new drug applications 

22 under section 505(i) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 

24 355(i)), or investigational test exemptions 

25 under section 587A(m) of the Federal 


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1 Food, Drug, and Cosmetic Act (as added 

2 by section 3), and activities conducted in 

3 anticipation of the submission of such ap4 plications under section 505(i) of the Fed5 eral Food, Drug, and Cosmetic Act or in6 vestigational use under section 587R of the 

7 Federal Food, Drug, and Cosmetic Act (as 

8 added by section 3). 

9 (vi) The development of guidance, pol10 icy documents, or regulations to improve 

11 the process for the review of premarket ap12 plications, technology certification applica13 tions, and supplements. 

14 (vii) The development of voluntary 

15 test methods, consensus standards, or 

16 mandatory performance standards in con17 nection with the review of such applica18 tions, supplements, or submissions and re19 lated activities. 

20 (viii) The provision of technical assist21 ance to in vitro clinical test developers in 

22 connection with the submission of such ap23 plications, reports, supplements, or submis24 sions. 


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1 (ix) Any activity undertaken in con2 nection with the initial classification or re3 classification of an in vitro clinical test in 

4 connection with any requirement for ap5 proval of an in vitro clinical test. 

6 (x) Evaluation of postmarket studies 

7 required as a condition of an approval of 

8 a premarket application of an in vitro clin9 ical test. 

10 (xi) Compiling, developing, and re11 viewing information on relevant in vitro 

12 clinical tests to identify issues with the ap13 plicable standard for premarket applica14 tions, technology certification applications, 

15 and supplements. 

16 (B) RESOURCE REQUIREMENTS.—Fees col17 lected and assessed under this section shall be 

18 used for the process for the review of in vitro 

19 clinical test applications, as described in sub20 paragraph (A), and shall— 

21 (i) be subject to the limitation under 

22 section 738(g)(3) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 

24 379j(g)(3)), in the same manner that fees 

25 collected and assessed under section 


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1 737(9)(C) of such Act (21 U.S.C. 

2 379i(9)(C)) are subject to such limitation; 

3 (ii) include travel expenses for officers 

4 and employees of the Food and Drug Ad5 ministration only if the Secretary deter6 mines that such travel is directly related to 

7 an activity described in subparagraph (A); 

8 and 

9 (iii) not be allocated to purposes de10 scribed under section 722(a) of the Con11 solidated Appropriations Act, 2018 (Public 

12 Law 115–141). 

13 (c) REPORTS.— 

14 (1) PERFORMANCE REPORT.— 

15 (A) IN GENERAL.— 

16 (i) GENERAL REQUIREMENTS.—Be17 ginning with fiscal year 2021, for each fis18 cal year for which fees are collected under 

19 this section, the Secretary shall prepare 

20 and submit to the Committee on Health, 

21 Education, Labor, and Pensions of the 

22 Senate and the Committee on Energy and 

23 Commerce of the House of Representatives 

24 annual reports concerning the progress of 

25 the Food and Drug Administration in 


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1 achieving the goals identified in the rec2 ommendations transmitted to Congress by 

3 the Secretary pursuant to subsection 

4 (b)(1)(E) during such fiscal year and the 

5 future plans of the Food and Drug Admin6 istration for meeting the goals. 

7 (ii) ADDITIONAL INFORMATION.—Be8 ginning with fiscal year 2021, the annual 

9 report under this subparagraph shall in10 clude the progress of the Food and Drug 

11 Administration in achieving the goals, and 

12 future plans for meeting the goals, includ13 ing— 

14 (I) the number of premarket ap15 plications filed under section 587B of 

16 the Federal Food, Drug, and Cos17 metic Act during the applicable fiscal 

18 year; 

19 (II) the number of technology 

20 certification applications submitted 

21 under section 587D of the Federal 

22 Food, Drug, and Cosmetic Act during 

23 the applicable fiscal year for each re24 view division; and 


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1 (III) the number of breakthrough 

2 designations under section 587C of 

3 the Federal Food, Drug, and Cos4 metic Act during the applicable fiscal 

5 year. 

6 (iii) REAL-TIME REPORTING.— 

7 (I) IN GENERAL.—Not later than 

8 30 calendar days after the end of the 

9 second quarter of fiscal year 2021, 

10 and not later than 30 calendar days 

11 after the end of each quarter of each 

12 fiscal year thereafter, the Secretary 

13 shall post the data described in sub14 clause (II) on the website of the Food 

15 and Drug Administration for such 

16 quarter and on a cumulative basis for 

17 such fiscal year, and may remove du18 plicative data from the annual report 

19 under this subparagraph. 

20 (II) DATA.—The Secretary shall 

21 post the following data in accordance 

22 with subclause (I): 

23 (aa) The number and titles 

24 of draft and final guidance on 

25 topics related to the process for 


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1 the review of in vitro clinical 

2 tests, and whether such guid3 ances were issued as required by 

4 statute or pursuant to the rec5 ommendations transmitted to 

6 Congress by the Secretary pursu7 ant to subsection (b)(1)(E). 

8 (bb) The number and titles 

9 of public meetings held on topics 

10 related to the process for the re11 view of in vitro clinical tests, and 

12 if such meetings were required by 

13 statute or pursuant to the rec14 ommendations transmitted to 

15 Congress by the Secretary pursu16 ant to subsection (b)(1)(E). 

17 (iv) RATIONALE FOR IVCT USER FEE

18 PROGRAM CHANGES.—Beginning with fis19 cal year 2022, the Secretary shall include 

20 in the annual performance report under 

21 paragraph (1)— 

22 (I) data, analysis, and discussion 

23 of the changes in the number of full24 time equivalents hired as agreed upon 

25 in the recommendations transmitted 


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1 to Congress by the Secretary pursuant 

2 to subsection (b)(1)(E) and the num3 ber of full-time equivalents funded by 

4 budget authority at the Food and 

5 Drug Administration by each division 

6 within the Center for Devices and Ra7 diological Health, the Center for Bio8 logics Evaluation and Research, the 

9 Office of Regulatory Affairs, and the 

10 Office of the Commissioner; 

11 (II) data, analysis, and discus12 sion of the changes in the fee revenue 

13 amounts and costs for the process for 

14 the review of in vitro clinical tests, in15 cluding identifying drivers of such 

16 changes; and 

17 (III) for each of the Center for 

18 Devices and Radiological Health, the 

19 Center for Biologics Evaluation and 

20 Research, the Office of Regulatory Af21 fairs, and the Office of the Commis22 sioner, the number of employees for 

23 whom time reporting is required and 

24 the number of employees for whom 

25 time reporting is not required. 


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1 (v) ANALYSIS.—For each fiscal year, 

2 the Secretary shall include in the report 

3 under clause (i) an analysis of the fol4 lowing: 

5 (I) The difference between the 

6 aggregate number of premarket appli7 cations filed under section 587B or 

8 section 587D of the Federal Food, 

9 Drug, and Cosmetic Act and the ag10 gregate number of major deficiency 

11 letters, not approvable letters, and de12 nials for such applications issued by 

13 the agency, accounting for— 

14 (aa) the number of applica15 tions filed under each of sections 

16 587B and 587D of the Federal 

17 Food, Drug, and Cosmetic Act 

18 during one fiscal year for which a 

19 decision is not scheduled to be 

20 made until the following fiscal 

21 year; and 

22 (bb) the aggregate number 

23 of applications under each of sec24 tions 587B and 587D of the 

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1 metic Act for each fiscal year 

2 that did not meet the goals as 

3 identified by the recommenda4 tions transmitted to Congress by 

5 the Secretary pursuant to sub6 section (b)(1)(E). 

7 (II) Relevant data to determine 

8 whether the Center for Devices and 

9 Radiological Health has met perform10 ance enhancement goals identified by 

11 the recommendations transmitted to 

12 Congress by the Secretary pursuant to 

13 subsection (b)(1)(E). 

14 (III) The most common causes 

15 and trends for external or other cir16 cumstances affecting the ability of the 

17 Food and Drug Administration to 

18 meet review time and performance en19 hancement goals identified by the rec20 ommendations transmitted to Con21 gress by the Secretary pursuant to 

22 subsection (b)(1)(E). 

23 (B) PUBLICATION.—With regard to infor24 mation to be reported by the Food and Drug 

25 Administration to industry on a quarterly and 


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1 annual basis pursuant to recommendations 

2 transmitted to Congress by the Secretary pur3 suant to subsection (b)(1)(E), the Secretary 

4 shall make such information publicly available 

5 on the website of the Food and Drug Adminis6 tration not later than 60 days after the end of 

7 each quarter or 120 days after the end of each 

8 fiscal year, respectively, to which such informa9 tion applies. 

10 (C) UPDATES.—The Secretary shall in11 clude in each report under subparagraph (A) 

12 information on all previous cohorts for which 

13 the Secretary has not given a complete response 

14 on all in vitro clinical test premarket applica15 tions and technology certification orders and 

16 supplements, premarket, and technology certifi17 cation notifications in the cohort. 

18 (2) CORRECTIVE ACTION REPORT.—Beginning 

19 with fiscal year 2022, for each fiscal year for which 

20 fees are collected under this section, the Secretary 

21 shall prepare and submit a corrective action report 

22 to the Committee on Health, Education, Labor, and 

23 Pensions and the Committee on Appropriations of 

24 the Senate and the Committee on Energy and Com25 merce and the Committee on Appropriations of the 


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1 House of Representatives. The report shall include 

2 the following information, as applicable: 

3 (A) GOALS MET.—For each fiscal year, if 

4 the Secretary determines, based on the analysis 

5 under paragraph (1)(A)(v), that each of the 

6 goals identified by the recommendations trans7 mitted to Congress by the Secretary pursuant 

8 to subsection (b)(1)(E) for the applicable fiscal 

9 year have been met, the corrective action report 

10 shall include recommendations on ways in which 

11 the Secretary can improve and streamline the in 

12 vitro clinical test premarket application and 

13 technology certification review process. 

14 (B) GOALS MISSED.—For each of the goals 

15 identified by the letters described in rec16 ommendations transmitted to Congress by the 

17 Secretary pursuant to subsection (b)(1)(E) for 

18 the applicable fiscal year that the Secretary de19 termines to not have been met, the corrective 

20 action report shall include— 

21 (i) a justification for such determina22 tion; 

23 (ii) a description of the types of cir24 cumstances, in the aggregate, under which 

25 applications or reports submitted under 


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1 sections 587B and 587D of the Federal 

2 Food, Drug, and Cosmetic Act missed the 

3 review goal times but were approved dur4 ing the first cycle review, as applicable; 

5 (iii) a summary and any trends with 

6 regard to the circumstances for which a re7 view goal was missed; and 

8 (iv) the performance enhancement 

9 goals that were not achieved during the 

10 previous fiscal year and a description of ef11 forts the Food and Drug Administration 

12 has put in place for the fiscal year in 

13 which the report is submitted to improve 

14 the ability of such agency to meet each 

15 such goal for the such fiscal year. 

16 (3) FISCAL REPORT.—For fiscal years 2021 

17 and annually thereafter, not later than 120 days 

18 after the end of each fiscal year during which fees 

19 are collected under this subpart, the Secretary shall 

20 prepare and submit to the Committee on Health, 

21 Education, Labor, and Pensions of the Senate and 

22 the Committee on Energy and Commerce of the 

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1 istration, of the fees collected during such fiscal year 

2 for which the report is made. 

3 (A) 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 (B) OPERATING RESERVE.—Such report 

9 shall provide the amount of operating reserve 

10 balance available each year, and any planned al11 locations or obligations of such balance that is 

12 above 10 weeks of operating reserve for the pro13 gram. 

14 (4) PUBLIC AVAILABILITY.—The Secretary 

15 shall make the reports required under paragraphs 

16 (1) through (3) available to the public on the website 

17 of the Food and Drug Administration. 

18 (5) ENHANCED COMMUNICATION.— 

19 (A) COMMUNICATIONS WITH CONGRESS.— 

20 Each fiscal year, as applicable and requested, 

21 representatives from the Centers with expertise 

22 in the review of in vitro clinical tests shall meet 

23 with representatives from the Committee on 

24 Health, Education, Labor, and Pensions of the 

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1 merce of the House of Representatives to report 

2 on the contents described in the reports under 

3 this section. 

4 (B) PARTICIPATION IN CONGRESSIONAL

5 HEARING.—Each fiscal year, as applicable and 

6 requested, representatives from the Food and 

7 Drug Administration shall participate in a pub8 lic hearing before the Committee on Health, 

9 Education, Labor, and Pensions of the Senate 

10 and the Committee on Energy and Commerce 

11 of the House of Representatives, to report on 

12 the contents described in the reports under this 

13 section. Such hearing shall occur not later than 

14 120 days after the end of each fiscal year for 

15 which fees are collected under this section. 

Æ 


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