The U.S. Food and Drug Administration (FDA) announced the fee increase for 2023. The costs change annually. This year they have truly exploded. The small business fee for the 510(k) assessment procedure alone has been increased by 55%.
All applications are affected by the price increases, including standard applications as:
- 510(k) Premarket Notifications (PMN),
- Premarket Approvals (PMA) and
- De Novo applications for classification.
The FDA's new fee regulations (Medical Device User Fee Amendment, MDUFA) will come into force on 1. October 2022, the start of the agency's 2023 annual reporting year. As usual, the fee schedule contains both standard rates and significantly lower fees for small businesses with annual sales of less than US$100 million.
The annual fees (establishment registration fee), which all economic operators registered with the FDA have to pay annually, also increase on a regular basis. It is possible to pause the annual re-registration if you can accept that you are not allowed to export Medical Devices to the USA. Your shipments would be stopped at customs if your FDA registration and FDA listing are not updated. You can reactivate the registration and listing at a later date.
The new fees for selected procedures are:
- Establishment annual fee: US$ 6,493 (there is no small business discount)
- Application fee 510(k) / PMN: US$ 19,870 or US$ 4,967 (small business).
- Application fee PMA,PDP,PMR,BLA: US$ 441,547 or US$ 110,387 (small business)
- De Novo Classification Request: US$ 132,464 bzw. US$ 33,116 (small business)
Further details and fees can be found on the pages of the FDA.
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