If your email program has trouble displaying this email, view as a webpage.

Medical Device User Fees for Fiscal Year 2025

On July 31, 2024, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice announcing medical device user fees and annual establishment registration fees for Fiscal Year 2025 (FY 2025), effective October 1, 2024, through September 30, 2025. The FDA also announced updates to the small business fee reductions.

More facts about the announcement:

• The establishment registration user fee for FY 2025 is $9,280.
  • There are no waivers or reductions for small establishments, businesses, or groups in FY 2025.
  • Learn more at Establishment Registration and Listing Fees.
• The FDA offers small business fee reductions and fee waiver for certain medical device submissions.
  • You must first be certified as a “small business” through CDRH’s Small Business Determination Program to be eligible.
  • Learn more at Reduced Medical Device User Fees: Small Business Determination (SBD) Program.

Questions?

If you have questions about user fees, medical device regulations, or other related questions, please visit Device Advice and CDRH Learn or contact the Division of Industry and Consumer Education (DICE).