New FDA Medical Device User Fees

August 7, 2024

2 mins

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Under the Medical Device User Fee Amendments (MDUFA), under the User Fee System of the FDA, medical device companies must pay fees to the FDA when they submit a premarket submission to seek approval for marketing a new medical device in the United States.

The FDA has recently published a set of new fees for the Fiscal Year of 2024 and 2025 they are as follows:

FDA Medical Device User Fees for the 2024 Fiscal year

The following includes the time frame between: October 1, 2023, through September 30, 2024:

FDA Medical device user fees for 2024

FDA Medical Device User Fees for 2025 Fiscal Year

The following includes the time frame between: October 1, 2024, through September 30, 2025

Additional Required Fees

- All manufacturers must pay an establishment registration fee.
- There are no waivers or reductions for small establishments, businesses or other groups.
- For small businesses there is a required fee certified by the Center for Devices and Radiological Health (CDRH).
- 510(k)s are required to pay a user fee which include Traditional, Abbreviated, and Special. There is no user fee for 510(k)s that are submitted to the FDA on behalf of an FDA third-party reviewer.

For more information about the required medical device user fees, click here.

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