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FY 2023- FDA Medical Device Registration Fees (User Fees)

FDA Medical Device Establishment registration fee for the year 2023 is USD 6,493. FDA fiscal year 2023 starts from October 1, 2022 and ends at September 30, 2023. Annual establishment registration fee must be paid between October 1, 2022 and December 31, 2022.

FDA Fees for Medical Device Registration and Applications for Fiscal Year 2023

FDA define small business as a business with $100 million or less in gross receipts or sales, including receipts or sales from its affiliates. In addition, if a small business has gross receipts or sales of $30 million or less, it is eligible to have the fee waived for its first PMA, PDP, PMR or BLA.

 

† 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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