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Reminder: FDA New Medical Device User Fees for FY 2023

Nov 07 2022

On October 5th, 2022, the FDA has announced the Fiscal Year (FY) 2023 fees under the MDUFA (Medical Device User Fee Amendments).

This fiscal year begins October 1st, 2022 and ends september 30th, 2023.

The purpose of this article is to remind those who still need to submit an initial registration or renew their registration. FDA will not consider medical device registrations to be complete unless all payments have been remitted.

*Warning: Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. must register annually with the FDA. If not, then disvantages, such as pending customs clearance and discontinuing production, may occur.

User Fees for FY2023

Annual Establishment Registration Fee: $6,493

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

Other fees for Fiscal Year 2023 (October 1, 2022 through September 30, 2023) are:

Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.

510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

If you have not renewed or submitted an initial registration, then please refer to this article.

Provision can help you determine what fees your facility is subject to and facilitate payment to FDA.

If you need an assistance, please contact us.

We will streamline the regulatory processes so that our clients can utilize

their time and money most efficiently.

Experience the best FDA approval directions and solutions!

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

Office 1-909-493-3276


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