FDA Medical Device User Fee Rates for FY 2024

The FDA has published the Medical Device User Fee rates applicable for Fiscal Year 2024. This notice serves to inform manufacturers of the updated fee structure that will be in effect for the upcoming fiscal year, as mandated by the Medical Device User Fee Amendments (MDUFA).

Medical device manufacturers subject to user fees should review the posted rates to ensure accurate financial planning and timely payment of applicable fees. While this notice primarily provides updated financial information, it is crucial for companies to consult the official FDA guidance and fee schedule to understand their specific obligations and any associated deadlines for payment to maintain compliance.