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  • Soledad

Medical Device User Fee Amendments (MDUFA)

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.

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