The Food and Drug Administration (FDA) has announced a public meeting entitled “Medical Device User Fee Amendments” in the October 7, Federal Register. 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 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 (the FD&C Act) directs FDA to publish the draft recommendations for the reauthorized program, 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.
The public meeting will be held on Wednesday, November 2, 2016, 9:00 a.m. – 5:00 p.m. at the FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503 (the Great Room), Silver Spring, MD, 20993.
If you wish to attend this public meeting in person, you must register by 4:00 p.m. on Wednesday, October 26, 2016 on the Medical Device User Fee Amendments Workshop Page. The meeting will be webcast and the webcast link will be posted after October 26, 2016. Registration is not required to view the webcast.
The draft MDUFA 4 Commitment Letter and proposed statutory changes will be posted on the Medical Device User Fee Amendments 2017 (MDUFA IV) website in mid-October.