Medical Device User Fee Amendments 2017 (MDUFA IV)

MDUFA IV Information and Other Reports

• MDUFA IV Independent Assessment (September 2021)
• MDUFA IV Independent Assessment of FDA's Review Process Management (December 2018) 
• FDA Voice Blog - FDARA: Making a Difference for Industry and Patients, August 21, 2017
• MDUFA Performance Goals and Procedures, Fiscal Years 2018 Through 2022
• Summary of Public Comments and Explanation of Changes to the MDUFA IV Recommendations

MDUFA IV Draft Recommendations

• Draft MDUFA Performance Goals and Procedures, Fiscal Years 2018 Through 2022
• Summary of Draft Recommended Changes to Statutory Language for MDUFA IV

MDUFA IV Federal Register Notices

• Federal Register: Public Meeting - Medical Device User Fee Amendments, November 2, 2016
• Federal Register: Medical Device User Fee Amendments; Public Meeting; Request for Comments

Industry Discussions on MDUFA IV Reauthorization

• FDA-Industry MDUFA IV Reauthorization Meeting, August 15, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, July 26, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, May 16, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, April 27, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, April 6-7, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting_March 4 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, February 18, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, January 27, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, January 20, 2016
• FDA-Industry MDUFA IV Reauthorization Meeting, December 15, 2015
• FDA-Industry MDUFA IV Reauthorization Meeting, November 18, 2015
• FDA-Industry MDUFA IV Reauthorization Meeting, October 1, 2015
• FDA-Industry MDUFA IV Reauthorization Meeting, September 9, 2015

Patient and Consumer Stakeholder Discussions on MDUFA IV Reauthorization

• Patient and Consumer Stakeholder Meeting Minutes, August 25, 2016
• Patient and Consumer Stakeholder Meeting Minutes, July 28, 2016
• Patient and Consumer Stakeholder Meeting Minutes, June 17, 2016
• Patient and Consumer Stakeholder Meeting Minutes, May 27, 2016
• Patient and Consumer Stakeholder Meeting Minutes, April 25, 2016
• Patient and Consumer Stakeholder Meeting Minutes, March 15, 2016
• Patient and Consumer Stakeholder Meeting Minutes, January 11, 2016
• Patient and Consumer Stakeholder Meeting Minutes, December 18, 2015
• Patient and Consumer Stakeholder Meeting Minutes, November 30, 2015
• Patient and Consumer Stakeholder Meeting Minutes, October 26, 2015
• Patient and Consumer Stakeholders Meeting Minutes, September 15, 2015