The U.S. FDA is holding a virtual public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027.  

This meeting will be held on April 19, 2022.

Medical Device User Fee Amendments authorizes the FDA to collect fees and use them for the process for the review of device applications. The current statutory authority for Medical Device User Fee Amendments expires on Sept. 30, 2022, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years.

Following negotiations with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs the 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
  • hold a meeting at which the public may present its views on such recommendations

The FDA will then consider such public views and comments and revise such recommendations as necessary.

The commitment letter for the meeting is posted in the docket and is available here.

Those who wish to attend this meeting must register by April 18, 2022.  There is no fee to register for the meeting.