FDA Announces New Medical Device User Fees for FY 2024
FDA announced its update on medical device user fees for FY 2024, which runs October 1, 2023 through September 30, 2024. The updated user fees affect everything from FDA medical device establishment registration to marketing submissions, and applies to all medical devices: beauty and cosmetic devices, therapeutic devices, medical equipment, diagnostic devices, and more.
As with prior years, the fees continue to increase, with the establishment registration fee increasing to $7,653 per establishment for FY 2024, up from $6,493 this past year. Unfortunately, FDA provides no waivers or reductions for small establishments, businesses or groups from the registration fees, but provides reduced filing fees for certain marketing applications.
Marketing submission fees have also increased with the 510(k) FY 2024 fee at $21,750 (standard fee) and $5,440 (small business fee). Similar fee increases are present for 513(g) Requests for Classification and other marketing applications. We advise small businesses to obtain, and/or re-file a Small Business application to obtain reduced filing fees. Small businesses with an approved Small Business Determination (SBD) with gross receipts or sales of $100 million or less are eligible for reduced filings fees for Premarket Notification (510(k)), De Novo Request, Premarket Applications (PMA) and other submissions.
We would also like to remind medical device facilities that are involved in the production and distribution of medical devices intended for the U.S. to renew your registration annually with the FDA. This includes contract manufacturers, contract sterilizers, initial importers, manufacturers, re-labelers, re-packagers, re-processors, specification developers, U.S. manufacturers of export only devices, and foreign exporters.
Companies must submit registration information between October 1 and December 31 this year, and must also renew listing information. See our Medical Device Registration FAQs for more information.
Garg Law is pleased to assist with FDA medical device establishment registration renewals or initial registrations, which can be requested here. Please also feel free to contact us with any questions on the new user fees or other device compliance or enforcement matters at info@garg-law.com.
