Public Meeting on the Reauthorization of MDUFA

Date: August 4, 2025

Time: 10:00 a.m. to 3:00 p.m.

In-Person Location: Great Room, FDA White Oak Campus (10903 New Hampshire Avenue, Silver Spring, MD, 20903). Enter at Building 1 to clear security.

Webinar Location: https://teams.microsoft.com/l/meetup-join/19%3ameeting_ODQ3YzUwMDEtODk3Zi00YTFhLWIwYzAtMmFjMzlkYzM5YzVh%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%22b991a8ee-e689-4dc1-bd5d-afa310d67246%22%7d

Description

The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting entitled “Medical Device User Fee Amendments.” The purpose of the public 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 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 FDA to continue collecting device user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin reauthorization by publishing a notice in the Federal Register requesting public input and holding a meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 - 2032. The comment period will close on September 4, and all comments will be published and available on FDA’s website.

There will be an opportunity for stakeholders to provide comments during an Open Public Comment session at the end of the meeting.

Additional information regarding how to provide comments can be found in the Federal Register Notice: Federal Register :: Public Inspection: Hearings, Meetings, Proceedings, etc.: Reauthorization of the Medical Device User Fee Amendments

Once available, the agenda and other meeting materials will be posted on FDA's website: Register for the FDA’s public meeting on the Reauthorization of the Medical Device User Fee Amendments - 08/04/2025 | FDA

If you need special accommodations due to a disability, please contact TURVRkFWSVJlYXV0aG9yaXphdGlvbiB8IGZkYSAhIGhocyAhIGdvdg== no later than July 25, 2025.

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