WASHINGTON, July 30 -- Food and Drug Administration has issued a notice called: Medical Device User Fee Rates for Fiscal Year 2026.
The notice was published in the Federal Register on July 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2026. 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...