What is the FDA annual registration fee for medical devices in 2026?
The FDA medical-device establishment registration fee for fiscal year 2026 is $11,423. FY 2026 ends September 30, 2026; the fee becomes $13,785 for FY 2027 beginning October 1, 2026.
Answer
The official FDA annual establishment-registration fee for medical devices is $11,423 for FY 2026, covering October 1, 2025, through September 30, 2026. Most establishments required to register must pay this amount before completing registration through the FDA Unified Registration and Listing System.
The word “2026” can create confusion because FDA fees follow the federal fiscal year rather than the calendar year. Registrations completed for FY 2027, which begins October 1, 2026, use the FY 2027 fee of $13,785. Therefore:
Payment before September 30, 2026, for FY 2026: $11,423
FY 2027 registration beginning October 1, 2026: $13,785
The fee normally applies to each qualifying establishment. It is not calculated according to the number of devices, company revenue, establishment size, or risk class. Qualified small businesses may receive reduced premarket-application fees, but there is no routine reduced establishment fee. A limited financial-hardship waiver may be available for certain qualified small businesses for annual registration other than initial registration.
The annual establishment fee does not include 510(k), De Novo, PMA, testing, consulting, U.S.-agent, or quality-system expenses. Companies should confirm both their facility activities and the applicable fiscal-year fee before initiating payment.
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