💊FDA Seeks Input on Medical Device User Fee Amendments Reauthorization
Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments
Summary
The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting entitled "Medical Device User Fee Amendments." The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2028 through 2032. 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, 2027. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin reauthorization by publishing a notice in the Federal Register requesting public input and holding a meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's public meeting regarding the reauthorization of the Medical Device User Fee Amendments (MDUFA) could significantly impact medical device companies through regulatory changes affecting user fees and associated processes. Stakeholder input may influence future compliance requirements, fees, and the efficiency of device reviews, directly impacting business operations and costs.