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Medical Device User Fees for Fiscal Year 2024

On July 28, 2023, 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 2024 (FY 2024), effective October 1, 2023, through September 30, 2024. The FDA also announced updates to the small business fee reductions.

More facts about the announcement:

• The establishment registration user fee for FY 2024 is $7,653.
  • There are no waivers or reductions for small establishments, businesses, or groups in FY 2024.
  • Learn more at Establishment Registration and Listing Fees
• The FDA is accepting Small Businesses Fee Reduction and Fee Waiver requests for FY 2024.
  • Before submitting a request, you must be certified as a “small business.”
  • Learn more at Reduced Medical Device User Fees: Small Business Determination (SBD) Program .

Questions?

If you have questions about this 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).