Sec. 826. Emergency use authorization

275 words·~1 min read·/bill/117/s/4348/rs/section-826

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Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— in subsection (a)— in paragraphs

(1)and (4)(C), by inserting in vitro clinical test, before or biological product each place such term appears; and in paragraph (2)(A), by striking or 515 and inserting 515, or 587B ; in subsection (e)— in paragraph (3)— in subparagraph (B), by striking and at the end; in subparagraph (C), by striking the period and inserting ; and ; and by adding at the end the following: quality requirements (with respect to in vitro clinical tests) under section 587K. ; and in paragraph (4)— in subparagraph (A), by striking ; or and inserting a semicolon; in subparagraph (B), by striking the period and inserting ; or ; and by adding at the end the following: with respect to in vitro clinical tests, requirements applicable to restricted in vitro clinical tests pursuant to section 587O. ; in subsection (m)— in the subsection heading, by striking inserting Laboratory tests associated with devices after in vitro clinical tests ; and devices in paragraph (1)— by striking to a device and inserting to an in vitro clinical test ; and by striking such device and inserting such in vitro clinical test . Section 564A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(a)(2)) is amended by inserting in vitro clinical test, after device, . Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b(2)) is amended— in subparagraph (A), by striking or 515 and inserting 515, or 587B ; and in subparagraph (B), by striking or 520 and inserting 520, or 587S.

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21 USC 360bbb–3
21 USC 360bbb–3a(a)(2)
21 USC 360bbb–3b(2)

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cites case law

Sec. 826

Emergency use authorization

Cite21 USC 360bbb–3

Cite21 USC 360bbb–3a(a)(2)

Cite21 USC 360bbb–3b(2)

Cites 3Cited by 0 across 0 sources