VALID Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 6102 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 HOUSE OF REPRESENTATIVES MARCH 5, 2020 Ms. DEGETTE (for herself and Mr. BUCSHON) introduced the following bill; which was referred to the Committee on Energy and Commerce 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Verifying Accurate Leading-edge IVCT Development Act 5 of 2020’’ or the ‘‘VALID Act of 2020’’. 6 (b) TABLE OF CONTENTS.—The table of contents of 7 this Act is as follows: 8 ‘‘Sec. 1. Short title; table of contents. ‘‘Sec. 2. Definitions. ‘‘Sec. 3. Regulation of in vitro clinical tests. VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 6102 IH ‘‘SUBCHAPTER J—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.’’. SEC. 2. DEFINITIONS. 1 (a) IN GENERAL.—Section 201 of the Federal Food, 2 Drug, and Cosmetic Act (21 U.S.C. 321) is amended— 3 (1) by adding at the end the following: 4 ‘‘(ss)(1) The term ‘in vitro clinical test’— 5 ‘‘(A) means a test intended by its developer (as 6 defined in section 587) to be used in the collection, 7 preparation, analysis, or in vitro clinical examination 8 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 6102 IH of specimens taken or derived from the human body 1 for the purpose of— 2 ‘‘(i) identifying or diagnosing a disease or 3 condition; 4 ‘‘(ii) providing information for diagnosing, 5 screening, measuring, detecting, predicting, 6 prognosing, analyzing, or monitoring a disease 7 or condition, including by making a determina- 8 tion of an individual’s state of health; or 9 ‘‘(iii) selecting, monitoring, or informing 10 therapy or treatment for a disease or condition; 11 and 12 ‘‘(B) may include— 13 ‘‘(i) a test protocol or laboratory test pro- 14 tocol; 15 ‘‘(ii) an instrument (as defined in section 16 587(11)); 17 ‘‘(iii) an article for taking, deriving, hold- 18 ing, or transporting specimens from the human 19 body (as defined in section 587(16)); 20 ‘‘(iv) software, excluding software that is 21 excluded by section 520(o) from the definition 22 of a device under section 201(h), and excluding 23 modifications that are exempt in accordance 24 with section 587A(l)(2)(A); and 25 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 6102 IH ‘‘(v) subject to subparagraph (2), a compo- 1 nent or part of a test, a test protocol, an instru- 2 ment, an article, or software described in any of 3 clauses (A) through (D) of such subparagraph, 4 whether alone or in combination, including re- 5 agents, calibrators, and controls. 6 ‘‘(2) Notwithstanding subparagraph (1)(v), an article 7 intended to be used as a component or part of an in vitro 8 clinical test described in subparagraph (1) is excluded 9 from the definition in subparagraph (1) if the article con- 10 sists of any of the following: 11 ‘‘(A) Blood, blood components, or human cells 12 or tissues, from the time of acquisition, donation, or 13 recovery of such article, including determination of 14 donor eligibility, as applicable, until such time as the 15 article is released as a component or part of an in 16 vitro clinical test by the establishment that collected 17 such article. 18 ‘‘(B) An article used for invasive sampling, a 19 needle, or a lancet, except to the extent such article, 20 needle, or lancet is an integral component of an arti- 21 cle for holding, storing, or transporting a specimen. 22 ‘‘(C) General purpose laboratory equipment, in- 23 cluding certain pre-analytical equipment, as deter- 24 mined by the Secretary. 25 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 6102 IH ‘‘(D) An article used solely for personal protec- 1 tion during the administering, conducting, or other- 2 wise performing of test activities.’’; 3 (2) by adding at the end of section 201(g) the 4 following: 5 ‘‘(3) The term ‘drug’ does not include an in vitro clin- 6 ical test.’’; and 7 (3) in section 201(h), by striking ‘‘section 8 520(o)’’ and inserting ‘‘section 520(o) or an in vitro 9 clinical test’’. 10 (b) EXCLUSION FROM DEFINITION OF BIOLOGICAL 11 PRODUCT.—Section 351(i)(1) of the Public Health Serv- 12 ice Act (42 U.S.C. 262(i)(1)) is amended— 13 (1) by striking ‘‘(1) The term ‘biological prod- 14 uct’ means’’ and inserting ‘‘(1)(A) The term ‘biologi- 15 cal product’ means’’; and 16 (2) by adding at the end the following: 17 ‘‘(B) The term ‘biological product’ does not in- 18 clude an in vitro clinical test as defined in section 19 201(ss) of the Federal Food, Drug, and Cosmetic 20 Act.’’. 21 (c) IN VITRO CLINICAL TEST DEFINITION.—In this 22 Act, the term ‘‘in vitro clinical test’’ has the meaning given 23 such term in section 201(ss) of the Federal Food, Drug, 24 and Cosmetic Act, as added by subsection (a). 25 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 6102 IH SEC. 3. REGULATION OF IN VITRO CLINICAL TESTS. 1 The Federal Food, Drug, and Cosmetic Act (21 2 U.S.C. 301 et seq.) is amended— 3 (1) by amending the heading of chapter V to 4 read as follows: ‘‘DRUGS, DEVICES, AND IN 5 VITRO CLINICAL TESTS’’; and 6 (2) by adding at the end of chapter V the fol- 7 lowing: 8 ‘‘Subchapter J—In Vitro Clinical Tests 9 ‘‘SEC. 587. DEFINITIONS. 10 ‘‘In this subchapter: 11 ‘‘(1) ANALYTICAL VALIDITY.— 12 ‘‘(A) The term ‘analytical validity’ means, 13 with respect to an in vitro clinical test, the abil- 14 ity of the in vitro clinical test, to— 15 ‘‘(i) sufficiently identify, measure, de- 16 tect, calculate, or analyze one or more 17 analytes, biomarkers, substances, or other 18 targets intended to be identified, measured, 19 detected, calculated, or analyzed by the 20 test; or 21 ‘‘(ii) as applicable, assist in such iden- 22 tification, measurement, detection, calcula- 23 tion, or analysis. 24 ‘‘(B) For an article for taking or deriving 25 specimens from the human body described in 26 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 6102 IH section 201(ss)(1)(B)(iii), the term ‘analytical 1 validity’ means that such article performs as in- 2 tended and will support the analytical validity 3 of an in vitro clinical test with which it is used. 4 ‘‘(2) APPLICABLE STANDARD.—The term ‘ap- 5 plicable standard’, with respect to an in vitro clinical 6 test, means a reasonable assurance of analytical and 7 clinical validity, except that such term— 8 ‘‘(A) with respect to test instruments, 9 means a reasonable assurance of analytical va- 10 lidity; and 11 ‘‘(B) with respect to articles for taking or 12 deriving specimens from the human body for 13 purposes described in clause (i) or (ii) of section 14 201(ss)(1)(A) means a reasonable assurance of 15 analytical validity and, where applicable, safety. 16 ‘‘(3) CLINICAL USE.—The term ‘clinical use’ 17 means the operation, application, or functioning of 18 an in vitro clinical test in connection with human 19 specimens, including patient, consumer, and donor 20 specimens, for the purpose for which it is intended 21 as described in section 201(ss)(1)(A). 22 ‘‘(4) CLINICAL VALIDITY.—The term ‘clinical 23 validity’ means the ability of an in vitro clinical test 24 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 6102 IH to achieve the purpose for which it is intended as de- 1 scribed in section 201(ss)(1)(A). 2 ‘‘(5) CROSS-REFERENCED TEST.—The term 3 ‘cross-referenced test’ means an in vitro clinical test 4 that references in its labeling the name or intended 5 use of another medical product that is not an in 6 vitro clinical test. 7 ‘‘(6) DEVELOP.—The term ‘develop’, with re- 8 spect to an in vitro clinical test, means— 9 ‘‘(A) designing, validating, producing, 10 manufacturing, remanufacturing, propagating, 11 or assembling an in vitro clinical test; 12 ‘‘(B) importing an in vitro clinical test; 13 ‘‘(C) modifying an in vitro clinical test ini- 14 tially developed by a different person in a man- 15 ner that— 16 ‘‘(i) changes any of the listing ele- 17 ments that define indications for use speci- 18 fied in paragraph (10), performance 19 claims, or, as applicable, the safety of such 20 in vitro clinical test; or 21 ‘‘(ii) affects the analytical or clinical 22 validity of the in vitro clinical test as in- 23 tended by the developer; or 24 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 6102 IH ‘‘(D) adopting, using, or disseminating for 1 use as an in vitro clinical test an article not 2 previously intended for clinical use. 3 ‘‘(7) DEVELOPER.—The term ‘developer’ means 4 a person who engages in an activity described in 5 paragraph (6) for clinical use. 6 ‘‘(8) FIRST OF A KIND.—The term ‘first-of-a- 7 kind’ means, with respect to an in vitro clinical test, 8 a test that has an intended use and a combination 9 of the elements specified in paragraph (10) that dif- 10 fer from the intended use and such elements of 11 other in vitro clinical tests that already are legally 12 available in the United States. 13 ‘‘(9) HIGH-RISK.— 14 ‘‘(A) IN GENERAL.—Subject to subpara- 15 graph (B), the term ‘high-risk’, with respect to 16 an in vitro clinical test or category of in vitro 17 clinical tests, means that an undetected inac- 18 curate result from such test or category— 19 ‘‘(i) presents potential unreasonable 20 risk for serious or irreversible harm or 21 death to a patient or patients, or would 22 otherwise cause serious harm to the public 23 health; or 24 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 6102 IH ‘‘(ii) is potentially likely to result in 1 the absence, delay, or discontinuation of 2 life-supporting or life-sustaining medical 3 treatment. 4 ‘‘(B) EXCEPTION.—The term ‘high-risk’ 5 does not include an in vitro clinical test de- 6 scribed in subparagraph (A) if mitigating meas- 7 ures are established and applied to sufficiently 8 mitigate the risk of inaccurate results as de- 9 scribed in subparagraph (A), including— 10 ‘‘(i) the degree to which the tech- 11 nology for the intended use of the in vitro 12 clinical test is well-characterized, and the 13 criteria for performance of the test are 14 well-established to be sufficient for the in- 15 tended use; and 16 ‘‘(ii) the clinical circumstances under 17 which the in vitro clinical test is used, and 18 the availability of other tests (such as con- 19 firmatory or adjunctive tests) or relevant 20 material standards. 21 ‘‘(10) INDICATIONS FOR USE.—The term ‘indi- 22 cations for use’ means one or more in vitro clinical 23 tests that have all of the following notification ele- 24 ments in common: 25 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 6102 IH ‘‘(A) Substance or substances measured by 1 the in vitro clinical test, such as an analyte, 2 protein, or pathogen. 3 ‘‘(B) Test method. 4 ‘‘(C) Test purpose or purposes, as de- 5 scribed in section 201(ss)(1)(A). 6 ‘‘(D) Diseases or conditions for which the 7 in vitro clinical test is intended for use, includ- 8 ing intended patient populations. 9 ‘‘(E) Context of use, such as in a clinical 10 laboratory, in a health care facility, prescription 11 home use, over-the-counter use, or direct-to- 12 consumer testing. 13 ‘‘(11) INSTRUMENT.—The term ‘instrument’ 14 means an in vitro clinical test that is hardware in- 15 tended by the hardware’s developer to be used with 16 one or more in vitro clinical tests to generate a clin- 17 ical test result, including software used to effectuate 18 the hardware’s functionality. 19 ‘‘(12) INSTRUMENT FAMILY.—The term ‘instru- 20 ment family’ means more than one instrument for 21 which the developer demonstrates and documents, 22 with respect to all such instruments, that all— 23 VerDate Sep 11 2014 01:17 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H6102.IH H6102 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 6102 IH ‘‘(A) have the same basic architecture, de- 1 sign, and performance characteristics, such as 2 tolerance limits and signal range; 3 ‘‘(B) have the same intended use or uses 4 and function; 5 ‘‘(C) share the same measurement prin- 6 ciples, detection methods, and reaction condi- 7 tions; and 8 ‘‘(D) produce the same or similar analyt- 9 ical results from samples of the same specimen 10 type or types. 11 ‘‘(13) LABORATORY OP [Text truncated for display. 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