WASHINGTON, D.C. — The Food and Drug Administration (FDA) has issued a Federal Register notice detailing the medical device user fees and annual establishment registration fees for Fiscal Year 2025 (FY 2025). These fees will be effective from October 1, 2024, through September 30, 2025. The notice also includes updates to the small business fee reductions.
The Medical Device User Fee and Modernization Act (MDUFMA) first established device user fees in 2002. These fees have been renewed multiple times through various amendments. The latest renewal, MDUFA V, extends the FDA’s authority to collect these fees until September 30, 2027.
Under this system, medical device companies pay fees when they submit premarket applications to market new medical devices in the U.S. and when they register their establishments and list their devices with the FDA. These fees enable the FDA to streamline regulatory processes, aiming to reduce the time required to bring safe and effective medical devices to market.
Small businesses can benefit from specific waivers and reduced fees under the Small Business Determination (SBD) program. Companies with gross receipts or sales of $30 million or less can have the fee waived for their first Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Report (PMR), or Biologics License Application (BLA). Additionally, businesses with gross receipts or sales of $100 million or less can receive reduced fees for various application types, including Premarket Notification (510(k)) and De Novo requests.
To qualify for these benefits, businesses must be certified through the SBD program. The program ensures that eligible companies receive fee reductions for certain types of submissions that require user fees.
The establishment registration fee, however, is not eligible for a reduced small business fee.
The FDA’s announcement underscores its commitment to supporting innovation while maintaining rigorous safety and efficacy standards for medical devices. The updated fee structure is designed to foster a more efficient review process, benefiting both industry and public health.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.