Public Meeting

The Food and Drug Administration (FDA) is announcing a 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) 2018 through 2022.  MDUFA authorizes FDA to collect fees and use them for the process for the review of medical device applications.  The current legislative authority for MDUFA expires October 1, 2017.  At that time, new legislation will be required for FDA to continue collecting medical device4 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 (the FDC Act) directs FDA to publish the draft recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such draft recommendations, and provide for a period of 30 days for the public to submit written comments on such draft recommendations.  FDA will then consider such public views and comments and revise such recommendations as necessary.

• Date, Time and Location
• Federal Register Notice
• Materials
• Registration
• Contact Us

FDA Campus Information

The meeting will be webcast and the webcast link will be posted here after October 26, 2016.

Federal Register Notice

The Federal Register notice announcing this public meeting and containing other information is available here:

• Meetings: Medical Device User Fee Amendments

[email protected].

For general questions regarding the public meeting please contact:

Aaron Josephson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5178, [email protected].