Sec. 8. Combination products
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Section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ) is amended— in paragraph (1)— in subparagraph (A), by striking or biological product and inserting in vitro clinical test (except for a product constituted of a device and an in vitro clinical test), or biological product ; in subparagraph (B), by adding at the end the following: For purposes of this Act, a product that constitutes a combination of a device and an in vitro clinical test is not a combination product within the meaning of this subsection and an in vitro clinical test that is offered as a separate product intended to inform the use of a drug, biological product, or device is not a combination product within the meaning of this subsection. ; and in subparagraph (D)(ii)— by inserting or in vitro clinical test after device ; and by inserting and in vitro clinical tests before shall ; in paragraph (3), by striking safety and effectiveness or substantial equivalence and inserting safety and effectiveness, substantial equivalence, or analytical validity and clinical validity before for the approved constituent part ; in paragraph (4)— in subparagraph (A), by striking or 513(f)(2) (submitted in accordance with paragraph (5)) and inserting 513(f)(2) (submitted in accordance with paragraph (5)), 587B, or 587D ; and in subparagraph (C), by striking or 515 and inserting 515, or 587B, or that is under an order under section 587D ; in paragraph (5)(A), by striking or 510(k) and inserting , 510(k), 587B, or 587D ; in paragraph (7), by striking or substantial equivalence and inserting , substantial equivalence, or analytical validity and clinical validity ; in paragraph (8), by adding at the end the following:
This paragraph shall not apply to a product constituted of a device and an in vitro clinical test. ; and in paragraph (9)— in subparagraph (C)(i), by striking or 520(g) and inserting 520(g), 587B, or 587D ; and in subparagraph (D), by striking or 520 and inserting 520, 587B, or 587D . Section 563 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–2 ) is amended by adding at the end the following: This section shall not apply to a product constituted of only a device and an in vitro clinical test. .
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- 21 USC 360bbb–2
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