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Event Title
Register for the FDA’s public meeting on the Reauthorization of the Medical Device User Fee Amendments
August 5, 2026

Date:
August 5, 2026
Time:
10:00 a.m. - 3:00 p.m. ET

The Food and Drug Administration (FDA) is announcing a hybrid 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) 2028 through 2032. MDUFA authorizes the 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 the FDA to continue collecting 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 the FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. The FDA will then consider such public views and comments and revise such recommendations as necessary.

Written comment from the public can be submitted at https://www.regulations.gov, Docket No. FDA-2026-N-6655

This webpage includes the following:

Federal Register Notice

Federal Register: Public Inspection: Hearings, Meetings, Proceedings, etc.: Medical Device User Fee Amendments

DATE AND TIME OF PUBLIC MEETING

August 5, 2026: 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

AGENDA

The FDA will post the agenda approximately 5 days before the meeting. 

REGISTRATION

Register for this event on Eventbrite:

Registration is free and available on a first-come, first-served basis.  

For general attendance, in-person registration will remain open through July 20, 2026, and virtual registration will remain open until 11:30 p.m. (ET) on August 4, 2026.

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 Ramsey, 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 17, 2026.

HOW TO REQUEST TO PRESENT AT THE PUBLIC MEETING

During online registration, you may indicate if you wish to speak during the public comment session. We will do our best to accommodate requests to make public comments. Individuals and organizations with 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 July 13, 2026 at 4:00 p.m. (ET), and any presentation materials must be emailed to Nia Ramsey (see CONTACT) no later than July 27, 2026.

Following the close of registration, 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 20, 2026. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

HOW TO COMMENT

The FDA is holding this meeting to provide information on the proposed recommendations for the reauthorization of MDUFA for FYs 2028 through 2031. In order to permit the widest possible opportunity to obtain public comment, the FDA is soliciting either electronic or written comments on all aspects of the meeting topics. The docket was opened on July 7, 2026.

The proposed commitment letter is available in the docket and on this website at:  https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa-fees/medical-device-user-fee-amendments-2028-mdufa-vi.

The docket will close on August 6, 2026, 30 days after publication of the proposed commitment letter.

As soon as a transcript is available, it will be posted in the docket and accessible at http://www.regulations.gov, and on this webpage.

2025 MDUFA Public Meeting

An initial meeting on the MDUFA reauthorization was held on August 4, 2025.

CONTACT

For questions about the meeting’s content, please contact:

Nia Ramsey
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

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