The U.S. Food and Drug Administration (FDA) fee increase for 2022 has been announced.
The costs will change annually. This affects the submission of marketing authorisation applications including
- 510(k) Premarket Notifications (PMN),
- Premarket Approvals (PMA) and
- De Novo applications for classification.
The FDA's new Medical Device User Fee Amendment (MDUFA) will take effect on 1 October 2021, the beginning of the agency's 2022 fiscal year. s usual, the fee schedule contains both standard rates and significantly lower fees for small businesses with annual sales of less than $100 million.
The annual fees (establishment registration fee), which all economic operators registered with the FDA have to pay annually, will also increase on a regular basis. It is possible to pause the annual re-registration if you can accept that you are not allowed to export medical devices to the USA. Your shipments would be stopped at customs if your FDA registration and FDA listing are not updated. You can reactivate the registration and listing at a later date.
The new fees for selected procedures are:
- Establishmentannual fee: US$ 5,672 (there is no small business discount)
- 510(k) / PMN application fee: 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 RequestUS$ 112,457 or US$ 28,114 (small business)
Further details and fees can be found on the FDA website.
If you still wish to submit your applications according to the old fee schedule, the application must be received and processed by the FDA before 1 October.
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