US Codex
Bill
Notes

To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

H.R. 2428 · 114th Congress · May 19, 2015 · Lineage

A BILL

Section 1 Humanitarian device exemption application

(a)
In general— Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended—
(1)
in paragraph (1) by striking “fewer than 4,000” and inserting “not more than 8,000”;
(2)
in paragraph (2)(A) by striking “fewer than 4,000” and inserting “not more than 8,000”; and
(3)
in paragraph (6)(A)(ii), by striking “4,000” and inserting “8,000”.
(b)
Guidance document on probable benefit— Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)).