VALID Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 2369 To amend the Federal Food, Drug, and Cosmetic Act with respect to in vitro clinical tests, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 29, 2023 Mr. BUCSHON (for himself and Ms. DEGETTE) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subse- quently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to in vitro clinical tests, and for other purposes. 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. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Verifying Accurate Leading-edge IVCT Development Act 5 of 2023’’ or the ‘‘VALID Act of 2023’’. 6 SEC. 2. DEFINITIONS. 7 (a) IN GENERAL.—Section 201 of the Federal Food, 8 Drug, and Cosmetic Act (21 U.S.C. 321) is amended— 9 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 2369 IH (1) by adding at the end the following: 1 ‘‘(ss)(1) The term ‘in vitro clinical test’ means an ar- 2 ticle specified in subparagraph (2) that is intended to be 3 used in the collection, preparation, analysis, or in vitro 4 clinical examination of specimens taken or derived from 5 the human body for the purpose of— 6 ‘‘(A) identifying or diagnosing a disease or con- 7 dition; 8 ‘‘(B) providing information for diagnosing, 9 screening, measuring, detecting, predicting, 10 prognosing, analyzing, or monitoring a disease or 11 condition, including by making a determination of 12 an individual’s state of health; or 13 ‘‘(C) selecting, monitoring, or informing ther- 14 apy or treatment for a disease or condition. 15 ‘‘(2) An article specified in this subparagraph is— 16 ‘‘(A) a test kit; 17 ‘‘(B) a test system; 18 ‘‘(C) a test protocol or laboratory test protocol; 19 ‘‘(D) an instrument (as defined in section 20 587(11)); 21 ‘‘(E) a specimen receptacle (as defined in sec- 22 tion 587(17)); 23 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 2369 IH ‘‘(F) software, excluding software that is ex- 1 cluded by section 520(o) from the definition of a de- 2 vice under section 201(h), that— 3 ‘‘(i) is a component or part of another in 4 vitro clinical test or analyzes, processes, or in- 5 terprets a signal or pattern from another in 6 vitro clinical test; and 7 ‘‘(ii) does not analyze, process, or interpret 8 a signal, pattern, or medical image from a de- 9 vice; and 10 ‘‘(G) subject to subparagraph (3), a component 11 or part of a test kit, a test system, a test protocol 12 or laboratory test protocol, an instrument, a speci- 13 men receptacle, or software described in subpara- 14 graph (F), whether alone or in combination, includ- 15 ing reagents, calibrators, and controls. 16 ‘‘(3) Notwithstanding subparagraph (2)(G), an arti- 17 cle intended to be used as a component or part of an in 18 vitro clinical test described in subparagraph (1) is ex- 19 cluded from the definition in subparagraph (1) if the arti- 20 cle consists of any of the following: 21 ‘‘(A) Blood, blood components, or human cells 22 or tissues, from the time of acquisition, donation, or 23 recovery of such article, including determination of 24 donor eligibility, as applicable, until such time as the 25 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 2369 IH article is released as a component or part of an in 1 vitro clinical test by the establishment that collected 2 such article. 3 ‘‘(B) An article used for invasive sampling, a 4 needle, or a lancet, except to the extent such article, 5 needle, or lancet is an integral component of an arti- 6 cle for holding, storing, or transporting a specimen. 7 ‘‘(C) General purpose laboratory equipment.’’; 8 (2) by adding at the end of paragraph (g) the 9 following: 10 ‘‘(3) The term ‘drug’ does not include an in vitro clin- 11 ical test.’’; and 12 (3) in paragraph (h)(1), in the matter following 13 clause (C), by striking ‘‘section 520(o)’’ and insert- 14 ing ‘‘section 520(o) or an in vitro clinical test’’. 15 (b) EXCLUSION FROM DEFINITION OF BIOLOGICAL 16 PRODUCT.—Section 351(i)(1) of the Public Health Serv- 17 ice Act (42 U.S.C. 262(i)(1)) is amended— 18 (1) by striking ‘‘(1) The term ‘biological prod- 19 uct’ means’’ and inserting ‘‘(1)(A) The term ‘biologi- 20 cal product’ means’’; and 21 (2) by adding at the end the following: 22 ‘‘(B) The term ‘biological product’ does not in- 23 clude an in vitro clinical test as defined in section 24 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 2369 IH 201(ss) of the Federal Food, Drug, and Cosmetic 1 Act.’’. 2 (c) IN VITRO CLINICAL TEST DEFINITION.—In this 3 Act, the term ‘‘in vitro clinical test’’ has the meaning given 4 such term in section 201(ss) of the Federal Food, Drug, 5 and Cosmetic Act, as added by subsection (a). 6 SEC. 3. REGULATION OF IN VITRO CLINICAL TESTS. 7 The Federal Food, Drug, and Cosmetic Act (21 8 U.S.C. 301 et seq.) is amended— 9 (1) by amending the heading of chapter V to 10 read as follows: ‘‘DRUGS, DEVICES, AND IN 11 VITRO CLINICAL TESTS’’; and 12 (2) by adding at the end of chapter V the fol- 13 lowing: 14 ‘‘Subchapter J—In Vitro Clinical Tests 15 ‘‘SEC. 587. DEFINITIONS. 16 ‘‘In this subchapter: 17 ‘‘(1) ANALYTICAL VALIDITY.—The term ‘ana- 18 lytical validity’ means, with respect to an in vitro 19 clinical test, the ability of the in vitro clinical test, 20 to identify, measure, detect, calculate, or analyze (or 21 assist in such identification, measurement, detection, 22 calculation, or analysis of) one or more analytes, bio- 23 markers, substances, or other targets intended to be 24 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 2369 IH identified, measured, detected, calculated, or ana- 1 lyzed by the test. 2 ‘‘(2) APPLICABLE STANDARD.—The term ‘ap- 3 plicable standard’, with respect to an in vitro clinical 4 test, means a reasonable assurance of analytical and 5 clinical validity for its indications for use, and a rea- 6 sonable assurance of safety for individuals who come 7 into contact with such in vitro clinical test, except 8 that such term, with respect to specimen receptacles 9 and test instruments, means a reasonable assurance 10 of analytical validity for its indications for use and 11 safety for individuals who come into contact with 12 such specimen receptacle or test instrument. 13 ‘‘(3) CLINICAL USE.—The term ‘clinical use’ 14 means the operation, application, or functioning of 15 an in vitro clinical test for the purpose for which it 16 is intended as described in section 201(ss)(1). 17 ‘‘(4) CLINICAL VALIDITY.—The term ‘clinical 18 validity’ means the ability of an in vitro clinical test 19 to achieve the purpose for which it is intended as de- 20 scribed in section 201(ss)(1). 21 ‘‘(5) COMPONENT OR PART.—The term ‘compo- 22 nent or part’ means a substance, piece, part, raw 23 material, software, firmware, labeling, or assembly, 24 including reagents, that is intended to be included as 25 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 2369 IH an aspect of an in vitro clinical test described in sec- 1 tion 201(ss)(1). 2 ‘‘(6) DEVELOP.—The term ‘develop’, with re- 3 spect to an in vitro clinical test, means— 4 ‘‘(A) designing, validating, producing, 5 manufacturing, remanufacturing, labeling, ad- 6 vertising, propagating, importing, or assembling 7 an in vitro clinical test; 8 ‘‘(B) modifying an in vitro clinical test, in- 9 cluding modifying the indications for use of the 10 in vitro clinical test, or modifying an article to 11 be an in vitro clinical test; or 12 ‘‘(C) establishing a test system as de- 13 scribed or included in a test protocol developed 14 by another entity unless such test protocol is 15 listed as an in vitro clinical test in the com- 16 prehensive test information system established 17 under section 587T by that other entity. 18 ‘‘(7) DEVELOPER.—The term ‘developer’ means 19 a person who engages in development as described in 20 paragraph (6), except the term does not include a 21 laboratory that— 22 ‘‘(A) is certified by the Secretary under 23 section 353 of the Public Health Service Act; 24 and 25 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 2369 IH ‘‘(B) assembles for use solely within that 1 laboratory, without otherwise developing, an in 2 vitro clinical test appropriately listed in the 3 comprehensive test information system estab- 4 lished under section 587T by a different person. 5 ‘‘(8) FIRST-OF-A-KIND.—The term ‘first-of-a- 6 kind’, with respect to an in vitro clinical test, means 7 that such test has any novel combination of the ele- 8 ments specified in paragraph (10) that differs from 9 in vitro clinical tests that already are legally avail- 10 able in the United States, except for such tests of- 11 fered under section 587C(a)(3), 587C(a)(4), or 12 587G. 13 ‘‘(9) HIGH-RISK.—The term ‘high-risk’, with 14 respect to an in vitro clinical test or category of in 15 vitro clinical tests, means that an undetected inac- 16 curate result from such test, or such category of 17 tests, when used as intended— 18 ‘‘(A)(i) is reasonably likely to result in se- 19 rious or irreversible harm or death to a patient 20 or patients, or would otherwise cause serious 21 harm to the public health; or 22 ‘‘(ii) is reasonably likely to result in the 23 absence, significant delay, or discontinuation of 24 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •HR 2369 IH life-supporting or life-sustaining medical treat- 1 ment; and 2 ‘‘(B) mitigating measures are not able to 3 be established and applied to prevent, mitigate, 4 or detect the inaccurate result, or otherwise suf- 5 ficiently mitigate the risk resulting from an un- 6 detected inaccurate result described in subpara- 7 graph (A), such that the test would be mod- 8 erate-risk or low-risk. 9 ‘‘(10) INDICATIONS FOR USE.—The term ‘indi- 10 cations for use’, with respect to an in vitro clinical 11 test, means the following elements: 12 ‘‘(A) Substance or substances measured by 13 the in vitro clinical test, such as an analyte, 14 protein, or pathogen. 15 ‘‘(B) Test method. 16 ‘‘(C) Test purpose or purposes, as de- 17 scribed in section 201(ss)(1). 18 ‘‘(D) Diseases or conditions for which the 19 in vitro clinical test is intended for use, includ- 20 ing intended patient populations. 21 ‘‘(E) Context of use, such as in a clinical 22 laboratory, in a health care facility, prescription 23 home use, over-the-counter use, or direct-to- 24 consumer testing. 25 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •HR 2369 IH ‘‘(11) INSTRUMENT.— 1 ‘‘(A) IN GENERAL.—The term ‘instrument’ 2 means an analytical or pre-analytical instru- 3 ment. 4 ‘‘(B) ANALYTIC INSTRUMENT.—The term 5 ‘analytic instrument’ means an in vitro clinical 6 test that is hardware intended by the developer 7 to be used with one or more other in vitro clin- 8 ical tests to generate a clinical test result, in- 9 cluding software used to effectuate the 10 functionality of the hardware. 11 ‘‘(C) PRE-ANALYTICAL INSTRUMENT.—The 12 term ‘pre-analytical instrument’ means an in 13 vitro clinical test that is hardware intended by 14 the developer solely to generate an output for 15 use exclusively with one or more analytical in- 16 struments as defined in subparagraph (B) and 17 which does not itself generate a clinical test re- 18 sult. Such term may include software used to 19 effectuate the hardware’s functionality. 20 ‘‘(12) INSTRUMENT FAMILY.—The term ‘instru- 21 ment family’ means more than one instrument devel- 22 oped by the same developer for which the developer 23 demonstrates and documents, with respect to all 24 such instruments, that all— 25 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •HR 2369 IH ‘‘(A) have the same basic architecture, de- 1 sign, and performance characteristics; 2 ‘‘(B) have the same indications for use and 3 capabilities; 4 ‘‘(C) share the same measurement prin- 5 ciples, detection methods, and reaction condi- 6 tions, as applicable; and 7 ‘‘(D) produce the same or similar analyt- 8 ical results from samples of the same specimen 9 type or types. 10 ‘‘(13) LABORATORY OPERATIONS.—The term 11 ‘laboratory operations’— 12 ‘‘(A) means the conduct of a laboratory ex- 13 amination or other laboratory procedure on ma- 14 terials derived from the human body, including 15 the conduct of an in vitro clinical test and asso- 16 ciated activities, that is— 17 ‘‘(i) regulated under section 353 of 18 the Public Health Service Act; and 19 ‘‘(ii) not related to the design, analyt- 20 ical validation, or clinical validation of an 21 in vitro clinical test; and 22 ‘‘(B) includes— 23 VerDate Sep 11 2014 03:11 Apr 08, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2369.IH H2369 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •HR 2369 IH ‘‘(i) performing pre-analytical and 1 post-analytical processes for an in vitro 2 clinical test; 3 ‘‘(ii) standard operating procedures 4 and the conduct thereof; and 5 ‘‘(iii) preparing reagents or other test 6 materials that do not meet the criteria for 7 being an in vitro clinical test for clinical 8 use. 9 ‘‘(14) LOW-RISK.—The term ‘low-risk’, with re- 10 spect to an in vitro clinical test or category of in 11 vitro clinical tests, means that an undetected inac- 12 curate result from such in vitro clinical test, or such 13 category of in vitro clinical tests, when used as in- 14 tended— 15 ‘‘(A) would cause only minimal or imme- 16 diately reversible harm, and would lead to only 17 a remote risk of adverse patient impact or ad- 18 verse public health i [Text truncated for display. 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