To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.

Bill: 117-hr-7679
Sponsor: full_name: Rep. Fletcher, Lizzie [D-TX-7]
Introduced: 2022-05-06
Policy area: Health
Latest action: action_date: 2022-05-06
text: Referred to the House Committee on Energy and Commerce.

Summaries:
action_date: 2022-05-06
action_desc: Introduced in House
text: <p>This bill reauthorizes through FY2027 (1) the Humanitarian Device Exemption Program (a specialized regulatory pathway for medical devices used to treat or diagnose diseases or conditions that affect no more than 8,000 individuals), and (2) the Pediatric Device Consortia Grants Program (a program that supports the development of medical devices for pediatric patients through nonprofit consortia).</p>

tv_txt: I 117th CONGRESS 2d Session H. R. 7679 IN THE HOUSE OF REPRESENTATIVES May 6, 2022 Mrs. Fletcher (for herself and Mr. Bilirakis ) 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 to reauthorize the authority to grant certain exemptions, and for other purposes.

1. Reauthorizing the humanitarian device exemption profit incentive Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act ( 42 U.S.C. 360j(m)(6)(A)(iv) ) is amended by striking 2022 and inserting 2027 . 2. Reauthorizing the pediatric device consortia program Section 305(e) of the Food and Drug Administration Amendments Act of 2007 ( 42 U.S.C. 282 note) is amended by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 .