FDA will host meetings to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, representatives from patient and consumer advocacy groups can discuss their views on reauthorization and provide suggestions for improving the program. The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program, and that FDA hold discussions with representatives of patient and consumer groups at least monthly during FDA's negotiations with the regulated industry.
Date, Time and Location:
- September 15, 2015 - COMPLETE
- October 26, 2015 - COMPLETE
- November 30, 2015 - COMPLETE
- December 18, 2015 - COMPLETE
- January 11, 2016 - COMPLETE
- February 16, 2016 - Cancelled
- March 15, 2016 - COMPLETE
- April 25, 2016 - COMPLETE
- May 27, 2016 - COMPLETE
- June 17, 2016 - COMPLETE
- July 28, 2016 - COMPLETE
- August 25, 2016
- ALL Patient and Consumer Stakeholder Meetings to discuss MDUFA Reauthorization will be held from 9 - 11 a.m. Eastern Time
- ALL Patient and Consumer Stakeholder Meetings to discuss MDUFA Reauthorization will be held at:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
- FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)
All participants should register by submitting the information below no later than 5 business days prior to the meeting dates.
Attendance at this meeting is "in person" only. It will not be webcast or recorded.
NOTE: Interested stakeholders should register only one time. FDA will contact you directly to confirm that you meet the criteria to attend these meetings. Once confirmed, FDA will contact you in advance of each meeting regarding your intent to attend.
Contact Shannon Thor at Shannon.Thor@fda.hhs.gov with any special accommodation needs.