The FDA has released the updated Medical Device User Fee Amendments (MDUFA) for Fiscal Year 2025, which spans from October 1, 2024, to September 30, 2025. For this period, the annual establishment registration fee is set at $9,280. This fee is mandatory for all new medical device establishments registering with the FDA in FY2025, as well as for existing establishments that wish to maintain their registration.
It's important to note that current registrants must renew their registration by December 31, 2024, within the FDA's three-month grace period.
The FY2025 registration fee represents a $1,627 increase from the FY2024 fee of $7,653.
In addition to the registration fee, the FDA has also updated the 510(k) application fees for FY2025. The standard fee is now $24,335, while the fee for small businesses is set at $6,084. These fees also reflect a significant increase compared to FY2024.
Details about FY2025 MDUFA can be found at the below link:
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