Medical Device User Fee Rates for Fiscal Year 2027

The Food and Drug Administration (FDA, Agency, or we) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2027, which apply from October 1, 2026, through September 30, 2027, and provides information on how the fees for FY 2027 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.