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    Health Law Daily Wrap Up, MEDICAL DEVICES—NOTICES: FDA announces medical device user fee rates for FY 2026, (Aug 4, 2025)

    By WK Editorial Staff

    The FDA announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2026.

    The federal Food, Drug, and Cosmetic Act (FDC Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes the F ...

    By WK Editorial Staff

    The FDA announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2026.

    The federal Food, Drug, and Cosmetic Act (FDC Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes the FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2026, which apply from October 1, 2025, through September 30, 2026, and provides information on how the fees for FY 2026 were determined, the payment procedures that should be followed, and how to qualify for reduced small business fees (Notice, 90 Fed. Reg. 35895 (July 30, 2025)).

    Dates. The notice establishes the fee rates for FY 2026, which apply from October 1, 2025, through September 30, 2026.

    FederalRegisterIssuances: Notices FDCActNews MDeviceNews

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