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INSIGHTS

August 16, 2023

Up, Up & Up!

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.

★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
R.G. Client
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Mike H. Client
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
Dr. Sastry Client
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
Claire P. Client

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