Medical Device User Fee Amendments 2022 (MDUFA V)

MDUFA IV and Beyond - Video Reports

• MDUFA IV Highlights and Accomplishments

MDUFA V Public Meetings

• Virtual Public Meeting April 19, 2022 - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
• Virtual Public Meeting October 27, 2020 - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027

MDUFA V Federal Register Notice

• Meetings: Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization
• Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments

MDUFA V Commitment Letter

• Draft: MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027
• Comments Due: April 21, 2022 - MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027
• Summary of Public Comments and Explanation of Changes to the MDUFA V Recommendations
• MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027
• An Introduction to the Medical Device User Fee Program: MDUFA V

Industry Discussions on MDUFA V Reauthorization

• FDA-Industry MDUFA V Reauthorization Meeting, March 15, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, March 7, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, March 3, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, March 2, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, February 24, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, February 22, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, February 15, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, February 10, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, February 8, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, February 3, 2022
• FDA-Industry MDUFA V Reauthorization Meeting, November 18, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, November 9, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, October 20, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, October 7, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, September 22, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, August 10, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, July 21, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, June 30, 2021 
• FDA-Industry MDUFA V Reauthorization Meeting, June 16, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, May 19, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, April 28, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, April 7, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, March 17, 2021
• FDA-Industry MDUFA V Reauthorization Meeting, February 24, 2021

Patient and Consumer Stakeholder Discussions on MDUFA V Reauthorization

• Stakeholder Consultation Meeting - MDUFA V Reauthorization, March 29, 2022
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, February 28, 2022
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, January 26, 2022
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, December 29, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, November 30, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, October 27, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, September 30, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, August 25, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, July 14, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, June 9, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, May 12, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, April 14, 2021
• Stakeholder Consultation Meeting - MDUFA V Reauthorization, March 10, 2021
• Stakeholder Consultation - Monthly Meeting Dates

MDUFA Real-World Evidence

• FDA Seeks Public Comment: Advancing Real-World Data and Real-World Evidence with User Fee Funding (MDUFA V)
• FDA Voices: Leveraging Real-World Evidence in Regulatory Submissions
• Report: Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions