Sec. 828. 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, or biological product (except for a product constituted of a device and an in vitro clinical test) ; in subparagraph (B), by adding at the end the following: For purposes of this Act, a product that constitutes a combination of a drug and an in vitro clinical test 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, or an exempt test under section 587C, as applicable ; and in subparagraph (B), by inserting , 587B, or 587D after section 515 ; 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 a device and an in vitro clinical test. .
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- 21 USC 360bbb–2
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