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