The Medical Device User Fee Amendments are the deal that funds FDA device review, and the current authority expires 30 September 2027. This hybrid public meeting — , 10 a.m. to 3 p.m. ET — is where the FDA presents its proposed recommendations for the FY 2028–2032 program and the public gets its statutory chance to respond.
Dates, venue and registration
- Meeting: 5 August 2026, 10 a.m.–3 p.m. ET
- Venue: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, White Oak Great Room, Silver Spring, MD
- Webcast: link published on the FDA event page
- In-person registration: open through 20 July 2026, first-come, first-served
- Virtual registration: open until 11:30 p.m. ET, 4 August 2026
- Organizer: US Food and Drug Administration
Why this meeting matters
MDUFA sets what device companies pay the FDA and what review performance the FDA commits to in return. The statute directs the agency to publish its reauthorization recommendations, hold this meeting for public comment, and take written comments for 30 days after — so what is said here shapes the user-fee contract every device manufacturer will operate under from FY 2028 through 2032.
Who should attend
Regulatory affairs and quality leaders in medical device companies of every size — user fees and review timelines hit start-ups and multinationals alike — plus regulatory policy, government affairs and market-access professionals who track FDA performance goals. If your organization intends to present its views, the FDA event page explains how to request a presentation slot; if you only want the record, the webcast requires nothing but registration before 4 August.
Watching the autumn calendar too? RAPS Convergence 2026 follows in September, and the full events directory lists everything we have verified.
Frequently asked questions
Is the MDUFA VI public meeting free to attend?
The FDA's event page lists no registration fee for either format. In-person seats in the White Oak Great Room are first-come, first-served, with registration open through 20 July 2026; virtual registration stays open until 11:30 p.m. ET on 4 August 2026.
Can I attend the MDUFA VI meeting virtually?
Yes. The meeting is hybrid: in the White Oak Great Room and webcast via a link on the FDA event page. Virtual registration closes at 11:30 p.m. ET on 4 August 2026.
What is MDUFA VI about?
MDUFA authorizes the FDA to collect user fees to fund device review. The current authority expires 30 September 2027, and this meeting presents the FDA's proposed recommendations for the FY 2028–2032 reauthorization for public comment, with a 30-day written-comment period after.
Sources & further reading
- FDA. Register for the FDA's public meeting on the Reauthorization of the Medical Device User Fee Amendments — 08/05/2026. fda.gov
Event details are published by the organizer and can change. Confirm dates, format and registration with the FDA before making plans. Last verified 16 July 2026.