Medical Device User Fee Amendments 2023

MDUFA IV and Beyond - Video Reports

• MDUFA IV Highlights and Accomplishments

MDUFA V Public Meetings

• Virtual Public Meeting - 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

Industry Discussions on MDUFA V Reauthorization

• 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 Meetings - Medical Device User Fee Amendments 2023 (MDUFA V)

MDUFA Real-World Evidence

• FDA Voices: Leveraging Real-World Evidence in Regulatory Submissions
• Report: Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions