Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments

Resumo

The Food and Drug Administration (FDA or the Agency) is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2023 through 2027 (MDUFA V). MDUFA authorizes FDA to collect user fees to support the process for the review of medical device applications. The current legislative authority for MDUFA expires after September 30, 2022, and new legislation will be required for FDA to continue collecting user fees for the medical device program in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin MDUFA reauthorization by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization, providing a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA, and publishing the comments on FDA's website.