The U.S. Food and Drug Administration (FDA) announced fees increase for 2022. The fees change annually.
Affected are submissions including but not limited to:
- 510(k) Premarket Notifications (PMN),
- Premarket Approvals (PMA) and
- De Novo applications for classification
The FDA’s new Medical Device User Fee Amendment (MDUFA) becomes effective Oct. 1, 2021, the start of the agency’s fiscal year 2022. As usual, the fee schedule includes both standard rates and significantly lower fees for small businesses (small business fees) with annual revenues of less than $100 million.
The annual fees (establishment registration fee), which all economic operators registered with the FDA have to pay annually, also increase on a rotational basis. It is possible to pause the annual re-registration if you accept that you will not be allowed to export medical devices to the USA. Your shipments will be stopped at customs if your listing is not updated.
The new fees for selected procedures are:
- Annual Establishment fee: US$ 5,672 (there is no small business discount).
- Application fee 510(k) / PMN: US$ 12,745 or US$ 3,186 (small business).
- Application fee PMA, PDP, PMR, BLA: US$ 374,858 or US$ 93,714 (small business)
- De Novo Classification Request: US$ 112,457 or US$ 28,114 (small business)
If you still wish to submit your requests under the old fee schedule, the request must be received and processed by the FDA before October 01.