Sec. 2. Definitions
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/bill/118/hr/2369/ih/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended— by adding at the end the following: The term in vitro clinical test means an article specified in subparagraph
(2)that is intended to be used in the collection, preparation, analysis, or in vitro clinical examination of specimens taken or derived from the human body for the purpose of— identifying or diagnosing a disease or condition; providing information for diagnosing, screening, measuring, detecting, predicting, prognosing, analyzing, or monitoring a disease or condition, including by making a determination of an individual’s state of health; or selecting, monitoring, or informing therapy or treatment for a disease or condition. An article specified in this subparagraph is— a test kit; a test system; a test protocol or laboratory test protocol; an instrument (as defined in section 587(11)); a specimen receptacle (as defined in section 587(17)); software, excluding software that is excluded by section 520(o) from the definition of a device under section 201(h), that— is a component or part of another in vitro clinical test or analyzes, processes, or interprets a signal or pattern from another in vitro clinical test; and does not analyze, process, or interpret a signal, pattern, or medical image from a device; and subject to subparagraph (3), a component or part of a test kit, a test system, a test protocol or laboratory test protocol, an instrument, a specimen receptacle, or software described in subparagraph (F), whether alone or in combination, including reagents, calibrators, and controls. Notwithstanding subparagraph (2)(G), an article intended to be used as a component or part of an in vitro clinical test described in subparagraph
(1)is excluded from the definition in subparagraph
(1)if the article consists of any of the following: Blood, blood components, or human cells or tissues, from the time of acquisition, donation, or recovery of such article, including determination of donor eligibility, as applicable, until such time as the article is released as a component or part of an in vitro clinical test by the establishment that collected such article. An article used for invasive sampling, a needle, or a lancet, except to the extent such article, needle, or lancet is an integral component of an article for holding, storing, or transporting a specimen. General purpose laboratory equipment. ; by adding at the end of paragraph
(g)the following: The term drug does not include an in vitro clinical test. ; and in paragraph (h)(1), in the matter following clause (C), by striking section 520(o) and inserting section 520(o) or an in vitro clinical test . Section 351(i)(1) of the Public Health Service Act ( 42 U.S.C. 262(i)(1) ) is amended— by striking
(1)The term and inserting biological product means (1)(A) The term ; and biological product means by adding at the end the following: The term biological product does not include an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act. . In this Act, the term in vitro clinical test has the meaning given such term in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
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