FDA announces fees for FY 2027

The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published the user fees applicable to submissions, etc for fiscal year 2027, running from 1 October 2026 to 30 September 2027. The new fees represent between a 10% and 20% increase over the 2026 fees. Further details are available from the FDA website.

As previously, for FY 2027, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses qualified through the Small Business Determination (SBD) Program who demonstrate that paying the fee represents financial hardship as determined by the FDA. For more information, visit Reduced Medical Device User Fees: Small Business Determination (SBD) Program.