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FDA Medical Device User Fees Increase 7% for 2021 Fiscal Year

FDA medical device user fees of both standard rates and small-business rates will slightly increase for 2021 fiscal year, which is October 1 2020 through September 2021.

The Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021) are as follows:

For small businesses with an approved SBD. Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

‡ Note: 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.

Annual Establishment Registration Fee also increase from $5,236 for 2020 to $5, 546 for 2021 with no waivers or reductions for small establishments, businesses, or groups.

US market applicants seeking to qualify for FDA’s 2020 user fee rates should submit premarket applications by September 30, 2020.


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