Device User Fee Increases Ease for FY 2026; FDA Will Consider Requests for Establishment Fee Waivers

Dennis Tosh
August 6, 2025 at 12:54 PM EST
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Increases in FDA medical device user fees eased for fiscal year (FY) 2026, with across-the-board increases of approximately 7.12%, compared with the more than 11.8% increases that device sponsors have faced during FY 2025. Moreover, while the agency’s annual device establishment registration fee will rise in FY 2026 by about 23.1% — an increase over the nearly 21.3% boost see... Read More

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