Zdrowie i gospodarka · 7.04.2022
Medical Device User Fee Amendments; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual public meeting entitled "Medical Device User Fee Amendments." The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2023 through 2027. MDUFA authorizes FDA to collect fees and use them for the process for the review of device applications. The current legislative authority for MDUFA expires September 30, 2022. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.