The U.S. Food and Drug Administration (FDA) has announced the fee increase for 2025.
The US Food and Drug Administration (FDA) has announced the new fees for 2025. As is the case every year, the fees will be adjusted. For the coming year, the annual fees for institutions will increase by about 18%, while the small business fees for the 510(k) review process will increase by about 11%.
All applications are affected by these price adjustments, including the current ones:
- 510(k) Premarket Notifications (PMN)
- Premarket Approvals (PMA)
- De Novo applications for classification
The FDA's new fee schedule, known as the Medical Device User Fee Amendment (MDUFA), will take effect on 1 October 2024, the start of the agency's 2025 fiscal year. As usual, the fee schedule includes both standard rates and reduced fees for small companies with annual revenues of less than $100 million.
Annual establishment fees, which are payable annually by all operators registered with the FDA, also increase periodically. Companies have the option of suspending their annual re-registration. However, this means that they cannot export medical devices to the US until the FDA registration and listing have been updated. Without a valid registration and listing, shipments will be stopped by customs. However, reactivation of registration and listing is possible at any time.
The new fees for selected procedures are:
- Establishment annual fee: 9,280 US dollars (no discount for small businesses)
- Application fee 510(k) / PMN: 24,335 US dollars or 6,084 US dollars (for small businesses)
- Antragsgebühr PMA, PDP, PMR, BLA: 540.783 US-Dollar bzw. 135.196 US-Dollar (für Kleinunternehmen)
- De Novo Classification Request: 162,235 US dollars or 40,559 US dollars (for small businesses)
Further details and a complete list of fees can be found on the official website of the FDA.
Important note: Anyone who submits their premarket notification (510(k)) application to the FDA before 1 October 2024 can benefit from the lower user fees for 2024. All applications submitted after 1 October 2024 will be subject to the higher fees for 2025.
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