Medical Device User Fee Amendments 2028 (MDUFA VI)

MDUFA VI Public Meetings

• August 5, 2026 – Medical Device User Fee Amendments (MDUFA VI) Public Meeting
• August 4, 2025 - Medical Device User Fee Amendments (MDUFA VI) Public Meeting

MDUFA VI Federal Register Notice

• Federal Register: Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments

DRAFT MDUFA VI Commitment Letter

• Draft: MDUFA Performance Goals and Procedures, Fiscal Years 2028 Through 2032
• Factsheet

Stakeholder Discussions on MDUFA VI Reauthorization

• Stakeholder Consultation Meetings - Medical Device User Fee Amendments 2028 (MDUFA VI)
• Stakeholder Consultation Meeting - MDUFA VI Reauthorization, October 27, 2025 [PDF 3.1 MB]
• Stakeholder Consultation Meeting - MDUFA VI Reauthorization, November 18, 2025 [PDF 184 KB]
• Stakeholder Consultation Meeting - MDUFA VI Reauthorization, December 4, 2025 [PDF 127 KB]
• Stakeholder Consultation Meeting - MDUFA VI Reauthorization, January 27, 2026 [PDF 381 KB]
• Stakeholder Consultation Meeting - MDUFA VI Reauthorization, February 25, 2026 [PDF 168 KB]
• Stakeholder Consultation Meeting - MDUFA VI Reauthorization, March 24, 2026 [PDF 173 KB]

Industry Discussions on MDUFA VI Reauthorization

• FDA-Industry MDUFA VI Reauthorization Meeting, October 29, 2025 [PDF 147 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, November 4, 2025 [PDF 135 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, November 20, 2025 [PDF 142 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, December 2, 2025 [PDF 143 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, December 11, 2025 [PDF 156 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, December 12, 2025 [PDF 152 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, January 8, 2026 [PDF 117 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, January 14, 2026 [PDF 135 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, January 21, 2026 [PDF 246 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, February 4, 2026 [PDF 134 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, February 11, 2026 [PDF 271 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, February 18, 2026 [PDF 152 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, March 11, 2026 [PDF 131 KB]
• FDA-Industry MDUFA VI Reauthorization Meeting, March 18, 2026 [PDF 250 KB]