Sec. 8. Combination products
343 words·~2 min read·
/bill/117/hr/4128/ih/section-8A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 inserting (except for a combination product constituted of a device and an in vitro clinical test) after agency center, ; and by inserting in vitro clinical test, before or biological product ; and in subparagraph (D)— in the matter preceding clause (i), by striking . If the Secretary determines and inserting , except for a combination product constituted of a device and an in vitro clinical test.
For other combination products, if the Secretary determines ; and in clause (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 an exempt test under section 587A, as applicable ; and in subparagraph (B), by inserting or 587B after section 515 ; in paragraph (5)(A), by striking or 510(k) and inserting , 510(k), or 587B ; 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 combination 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), or 587B ; and in subparagraph (D), by striking or 520 and inserting 520, or 587B . 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 combination product constituted of a device and an in vitro clinical test. .
Connectionstraces to 1
Traces to 1 document
1 reference not yet in our index
- 21 USC 360bbb–2
Citation graph
cites case law
Cites 2Cited by 0 across 0 sources