Medical Device User Fees for Fiscal Year 2026

On July 30, 2025, 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 2026 (FY 2026), effective October 1, 2025, through September 30, 2026. The FDA also announced updates to the small business fee reductions.

More facts about the announcement:

• The establishment registration user fee for FY 2026 is $11,423.
  • For FY 2026, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses certified through the Small Business Determination (SBD) Program who demonstrate that paying the fee would represent a financial hardship as determined by the FDA.
  • Learn more at Establishment Registration and Listing Fees.
• The FDA offers small business fee reductions and fee waivers for certain medical device submissions.
  • You must first be qualified and determined to be a “small business” through CDRH’s SBD Program to be eligible.
  • Learn more at Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program.