Stakeholder Consultation Meetings - Medical Device User Fee Amendments 2028 (MDUFA VI)
Purpose
The U.S. Food and Drug Administration (FDA) will host periodic stakeholder consultation meetings on the reauthorization of the Fiscal Years 2028 to 2032 Medical Device User Fee Amendments (MDUFA VI). During these meetings, public stakeholders — including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts — can discuss their views on the MDUFA VI reauthorization and provide suggestions for improving the program for consideration.
MDUFA authorizes the FDA to collect user fees from the regulated industry for the process for the review of medical devices. The authorization for the current program (MDUFA V) expires on 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) requires that the FDA hold discussions (at least every month) with patient and consumer advocacy groups during the FDA's negotiations with the regulated industry. The purpose is to ensure continuity and progress in these monthly discussions by establishing consistent public stakeholder representation. The FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions.
Dates and Location
The FDA will hold monthly stakeholder consultations meetings at the FDA White Oak campus and/or virtually on the following dates:
- October 27, 2025
- November 18, 2025
- December 4, 2025
- January 27, 2026
- February 25, 2026
Contact
If you have questions, please email them to MDUFAVIReauthorization@fda.hhs.gov.