The Medical Device User Fees (MDUFA) have been announced for FY 2026! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, and ADUFA.
Across the board, for both standard and small businesses, fees increased by 7.1% with the exception of establishment fees, which increased by a whopping 23.1% for both standard and small businesses!
Unlike most of the other user fee programs, MDUFA has a category for small businesses, which qualify for significantly reduced fees. You may be asking, how do I qualify as a small business for the purpose of medical device fees? The FR Notice states that if your business, including affiliates, has gross receipts of < $100 million for the most recent tax year, you may qualify. There are additional waivers that may apply to your first premarket application if your business, including affiliates, has gross receipts of < $30 million. For FY 2026, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to applicants that qualify if the FDA determines that the establishment is a small business and paying the fee for such a year represents a financial hardship to the establishment. For the purpose of the annual registration fee waiver, a small business is defined as one with < $1,000,000 gross receipts or sales per the most recent tax returns (including its affiliates). For more information on obtaining such waivers, see the FDA’s Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff, and Foreign Governments (here), which describes the FDA’s current thinking on the topic. Note, you must submit information to qualify as a small business for each fiscal year in order to pay the reduced fees. Please see the FR Notice for additional details on what information to submit and how to submit it, or reach out us at Lachman Consultants—we can guide you through the process.
As stated in FR Notice, the new user fees will be effective on October 1, 2025. To avoid delay in review of your application, you must pay the application fee at the time the application is submitted to the FDA. This is especially critical for a submission that is made around the October 1, 2025 deadline as the later of the dates between when the application is received or when the U.S. Treasury recognizes the payment determines whether the FY 2025 or FY 2026 fees will be applied. For periodic reporting for PMAs, you will be invoiced at the end of the quarter in which your PMA periodic report is due. Companies that do not manufacture any product other than a licensed biologic are required to register in the Blood Establishment Registration (BER) system. The FDA’s Center for Biologics Evaluation and Research (CBER) will send establishment registration fee invoices annually to these companies. All other establishment registrations are paid through the FDA Unified Registration and Listing System (FURLS) and are due by December 31, 2025.
