Purpose:
To discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, representatives from patient and consumer advocacy groups can hear updates on the FDA-Industry negotiations and provide their 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 FDC 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:
This meeting will be held on September 15, 2015, from 9 – 11 a.m. Eastern Time, at the following location:
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.)
Additional patient and consumer stakeholder meetings are scheduled for October 26, 2015, November 30, 2015, December 18, 2015, January 11, 2016, and February 16, 2016. All meetings will take place from 9-11 a.m. Eastern Time.
Registration:
All participants are required to register by submitting the information below no later than 2 business days prior to the meeting date.
Attendance at this meeting is “in person” only. It will not be webcast or recorded.
Minutes of the meeting will be posted to the MDUFA website approximately 1 week after each meeting date.
Contact Shannon Thor at [email protected] with any special accommodation needs.
