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 reauthorization critical for device manufacturers? - What are the key proposed changes for MDUFA VI covering fiscal years 2028-2032? - How might new performance goals impact 510(k) and PMA review timelines? - What new initiatives for digital health and AI/ML devices are being considered? - When is the public meeting and how can manufacturers provide input? - What are the potential financial implications of the proposed user fee structure? - How does MDUFA VI aim to enhance the pre-submission and post-market processes? - What practical steps should regulatory teams take now to prepare? Sources: - https://www.federalregister.gov/documents/2026/07/07/2026-14531/medical-device-user-fee-amendments-public-meeting-request-for-comments - https://www.fda.gov/news-events/cdrh-new-news-and-updates/july-7-2026-register-fdas-public-meeting-reauthorization-medical-device-user-fee-amendments How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex regulatory landscapes like the MDUFA reauthorization. Our experts develop efficient market access strategies, manage technical dossier submissions, and provide continuous regulatory monitoring to ensure your products remain compliant. By combining local expertise in over 30 markets with advanced AI tools, we streamline the registration process, saving you time and resources. Whether you're a startup or a multinational, we can help you prepare for MDUFA VI and accelerate your global expansion. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.