October 27, 2020
9:00 a.m. - 2:00 p.m.
The U.S. Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V). The current legislative authority for the medical device user fee program expires on September 30, 2022. New legislation is required for the FDA to continue to collect user fees for the medical device program in future fiscal years.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before the FDA begins negotiations with the regulated industry on MDUFA reauthorization, we must take the following steps:
Federal Register Notice: https://www.federalregister.gov/documents/2020/09/08/2020-19771/medical-device-user-fee-amendments-for-fiscal-years-2023-through-2027-public-meeting-request-for