US FDA Medical Device User Fees See Modest Increase for 2022

The US Food and Drug Administration has set a 2.5% increase for 2022 fiscal year fees charged to medical device market applicants seeking 510(k) clearance, Premarket Approval (PMA), De Novo or other registrations in order to sell their products on the US market.

The fee increases take effect at the beginning of FDA’s 2022 fiscal year, starting October 1, 2021 through September 20, 2022.  This 2.5% increase is less steep than the agency’s seven-percent increase for 2021; nonetheless, medical device manufacturers seeking to qualify for the agency’s current fee schedule should submit premarket applications by no later than September 30, 2021.

Standard FDA medical device user fees for 2022

Small-business user fees for 2022

FDA will continue offering discounted user fee rates for medical device registrants qualifying as small businesses. Companies with $100 million or less in sales for their most recent tax years qualify for the small business designation.

FDA Establishment Registration fees, which any company that manufactures, imports or reprocesses a medical device or IVD for sale in the US must pay, will increase by about two percent to $5,672 for the agency’s 2022 fiscal year, up from $5,546 in 2021. As in previous years, no small-business discount is applicable to the FDA Establishment Registration fee.

Additional 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