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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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''.

SEC. 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''.
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To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.
Official Titles - House of Representatives
Official Title as Introduced
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.
Rep. Fletcher, Lizzie