Meeting | Mixed
Event Title
Register for the FDA’s public meeting on the Reauthorization of the Medical Device User Fee Amendments
August 4, 2025
- Date:
- August 4, 2025
- Time:
- 10:00 a.m. - 3:00 p.m. ET
Attend
The U.S. Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI). The current legislative authority for the medical device user fee program expires on Sept. 30, 2027. New legislation is required for the FDA to continue to collect user fees for the medical device program in future fiscal years.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before the FDA begins negotiations with the regulated industry on MDUFA reauthorization, the Agency take the following steps:
- Publish a notice in the Federal Register requesting public input on the reauthorization,
- Hold a public meeting at which the public may present its views on the reauthorization,
- Provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA, and
- Publish the comments on the FDA’s website.
A notice was published in the Federal Register requesting public input on the reauthorization on June 10, 2025. The FDA invites public comment on four specific questions related to the medical device user fee program and the commitments the FDA should propose for the next reauthorized program:
(1) What is your assessment of the overall performance of MDUFA V thus far?
(2) What current features of MDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the medical device review process?
(3) What new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the medical devices review process?
(4) What changes, if any, could be made to the current fee structures and amounts to better advance the goals of the agreement, including facilitating product development and timely access for consumers?
Written comment from the public can be submitted at https://www.regulations.gov/, Docket No. FDA-2025-N-1157
This webpage includes the following:
Date and Time of Public Meeting
How to Request to Present at the Public Meeting
DATE AND TIME OF PUBLIC MEETING
August 4, 2025: The public meeting will take place from 10 a.m. to 3 p.m. ET
LOCATION OF PUBLIC MEETING
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the White Oak Great Room, Silver Spring, MD 20993-0002
WEBCAST LINK
The webcast link will be available after August 1, 2025.
AGENDA
The FDA will post the agenda for the public meeting by July 28, 2025
REGISTRATION
For general attendance, in-person registration will remain open through July 29, 2025, and virtual registration will remain open until 4:00 p.m. (ET) on August 3, 2025.
Registrants will receive confirmation when requests for participation have been accepted, if applicable. The FDA will update this web page if registration closes before the day of the public meeting.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Nia Benjamin, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796- 5424, MDUFAVIReauthorization@fda.hhs.gov, by July 16, 2025.
HOW TO REQUEST TO PRESENT AT THE PUBLIC MEETING
During online registration, you may indicate if you wish to speak during a public comment session, and which specific question you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with responses to the same questions or have common interests are encouraged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions.
Requests to make oral presentations must be received by the close of registration on July 7, 2025 at 4:00 p.m. (ET), and any presentation materials must be emailed to Nia Benjamin (see CONTACT) no later than July 28, 2025.
Following the close of registration on July 7, 2025, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will notify participants by July 14, 2025. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.
HOW TO COMMENT
The FDA is seeking comments to four specific questions related to the current medical device user fee program and the commitments FDA should propose for the reauthorized program. Comments can be submitted at https://www.regulations.gov/, Docket No. FDA-2020-N-1157. Additionally, any other pertinent information that stakeholders would like to share is welcomed by September 4, 2025.
Please refer to the Federal Register notice for the specific questions and submitting comments to the docket to ensure that your feedback is received.
The FDA will consider discussions from the meeting and comments received in the docket.
As soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.
CONTACT
For questions about the meeting’s content, please contact:
Nia Benjamin
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, Rm. 5422
Silver Spring, MD 20993
301-796-5424
MDUFAVIReauthorization@fda.hhs.gov