Public Meeting on the Reauthorization of MDUFA (MDUFA VI)

The Food and Drug Administration (FDA, the Agency, or we) is announcing a hybrid public meeting titled “Medical Device User Fee Amendments.”
About this Event

Date: Wednesday, August 5, 2026

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

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

Webinar Information: https://teams.microsoft.com/l/meetup-join/19%3ameeting_ZDY3YWY1MDctNDU2MS00YjQyLTg2MTAtMmU3OGVjMzgzMDJl%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%22f46007e5-06e8-46b8-8ed0-45459ca51924%22%7d

Description

The Food and Drug Administration is announcing a hybrid public meeting titled “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. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs 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. FDA will then consider such public views and comments and revise such recommendations as necessary. The draft commitment letter is posted in the docket and also 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 30 days after those documents are made publicly available. Submit electronic or written comments to the public docket within 30 days of publication.

There will be an opportunity for stakeholders to provide comments during an Open Public Comment session at the end of the meeting. Requests to make oral presentations must be received by July 20, 2026 at 11:59 pm (ET).

Additional information regarding how to provide comments can be found in the Federal Register Notice: Federal Register :: Medical Device User Fee Amendments; Public Meeting; Request for Comments

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 - 08/05/2026 | FDA

If you need special accommodations due to a disability, please contact [email protected] no later than .