US FDA Medical Device User Fees Increase 7% for 2021

The US Food and Drug Administration plans seven-percent medical device user fee increases for the 2021 fiscal year, raising costs slightly for premarket submissions including 510(k) Premarket Notifications, Premarket Authorizations (PMA) and De Novo requests for classification.

FDA’s new Medical Device User Fee Amendment (MDUFA) fee schedule comes into effect October 1, 2020, the start of the agency’s 2021 fiscal year. As usual, the fee schedule features both standard rates as well as significantly lower small-business rates for qualifying manufacturers.

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

Standard FDA medical device user fees for 2021

The agency’s standard-rate  user fees for 2021 are listed below:

Small-business medical device user fees for 2021

Manufacturers with gross receipts or sales of $100 million or less for their most recent fiscal years may qualify as small businesses under FDA’s Small Business Determination (SBD) Program, and are eligible for reduced user fees for most FDA premarket submissions. Small-business FDA user fees will also undergo a seven-percent increase for 2021:

Furthermore, SBD-qualified firms with sales of $30 million or less may have fees waived completely for their first PMA submitted for FDA review.

FDA Annual Establishment Registration fees also increase

FDA Establishment Registration fees, applicable to any company producing, importing or reprocessing medical devices and IVDs for sale in the US, will also increase by about six percent for FDA’s 2021 fiscal year

Establishment Registration fees will rise from $5,236 for 2020 to $5, 546 for 2021. No small-business discounts are available for this fee.

Related US FDA medical device regulatory resources from Emergo by UL:

• US FDA submission consulting for medical device and IVD manufacturers
• US FDA medical device Establishment Registration and FURLS listing support