H.R. 2428 — Introduced in House

I 114th CONGRESS 1st Session H. R. 2428 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Shimkus introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. 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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act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)).