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FDA MDUFA VI Reauthorization: What to Expect for FY 2028-2032
The US FDA has announced a public meeting on July 22, 2026, to discuss the proposed recommendations for the sixth reauthorization of the Medical Device User Fee Amendments (MDUFA VI). This episode breaks down the MDUFA framework, explores the key proposed changes for fiscal years 2028-2032, and analyzes the impact on manufacturers. We cover potential changes to submission review timelines, new initiatives for digital health and AI/ML devices, and the expected adjustments to user fees, providing practical steps for regulatory teams to prepare. Key Questions: - What is MDUFA and why is its…
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