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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.
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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).
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
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Sources: Congress.gov