FDA MDUFA VI Fees: Proposed Increases for Overseas Manufacturers

Medical Device Global Market Access · Aug 14, 2026 · 4m

The US FDA is considering higher user fees for overseas medical device manufacturers under the proposed MDUFA VI agreement for fiscal years 2028-2032. This episode breaks down the key takeaways from the FDA's public meeting on August 10, 2026, including the agency's rationale for the increase, the potential financial impact on non-US firms, and the critical deadlines for submitting public feedback before the proposal goes to Congress in January 2027. Key Questions: - What is MDUFA VI and why is it important for medical device manufacturers? - What specific fee changes are being proposed for…