Medical Device User Fee Amendments 2012 (MDUFA III)
Information about MDUFA III
- MDUFA III Commitment Letter
- Fact Sheet: Medical Device User Fee Amendments of 2012
- Food and Drug Administration Safety and Innovation Act (FDASIA)
MDUFA III Federal Register Notices
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2015
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2014
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2013
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2012
Industry Discussions on MDUFA III Reauthorization
- February 17, 2012 [Archived]
- February 16, 2012 [Archived]
- February 14, 2012 [Archived]
- February 10, 2012 [Archived]
- February 8, 2012 [Archived]
- January 31, 2012 [Archived]
- January 5, 2012 [Archived]
- December 13, 2011 [Archived]
- December 6, 2011 [Archived]
- November 29, 2011 [Archived]
- November 18, 2011 [Archived]
- November 10, 2011 [Archived]
- November 3, 2011 [Archived]
- October 31, 2011 [Archived]
- October 26, 2011 [Archived]
- October 21, 2011 [Archived]
- October 6, 2011 [Archived]
- September 29, 2011 [Archived]
- September 13, 2011 [Archived]
- August 31, 2011 [Archive]
- August 24, 2011 [Archived]
- August 9, 2011 [Archived]
- August 2, 2011 [Archived]
- July 26, 2011 [Archive]
- July 15, 2011 [Archived]
- June 27, 2011 [Archived]
- June 17, 2011 [Archived]
- June 1, 2011 [Archived]
- May 4, 2011 [Archived]
- April 13, 2011 [Archived]
- March 30, 2011 [Archived]
- March 7, 2011 [Archived]
- February 23, 2011 [Archived]
- February 9, 2011 [Archived]
- January 26, 2011 [Archived]
Stakeholder Discussions on MDUFA III Reauthorization
- February 28, 2012 [Archived]
- January 26, 2012 [Archived]
- December 20, 2011 [Archived]
- November 17, 2011 [Archived]
- October 13, 2011 [Archived]
- September 6, 2011 [Archived]
- August 18, 2011 [Archived]
- July 27, 2011 [Archived]
- June 16, 2011 [Archived]
- May 19, 2011 [Archived]
- April 27, 2011 [Archived]
- March 22, 2011 [Archived]
- February 16, 2011 [Archived]
- January 13, 2011 [Archived]
Additional Reports
- FDA Implementation Plan for Final Recommendations - December 2014 [Archived]
- FDA Implementation Plan for Priority Recommendations - June 2014 [Archived]
- MDUFA III Evaluation Final Report on Findings and Recommendations - June 2014 [Archived]
- MDUFA III Independent Assesment Statement of Work - 2012 [Archived]
- MDUFA III Independent Assesment Statement of Work 2013, final draft after making revisions made based on feedback from the FR Notice comments [Archived]
- MDUFA III Independent Assessment Phase 1 High Priority Recommendations [Archived]
- MDUFA III Independent Assessment of FDA Device Review Process Management - Phase 2