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

Bill: 114-hr-2428
Sponsor: full_name: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Health technology, devices, supplies
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-19
action_desc: Introduced in House
text: <p>This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.</p> Within 18 months of enactment of this Act, the FDA must define &ldquo;probable benefit&rdquo; for these devices.

tv_txt: 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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (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) ).