Public Comment of Generation Patient, National Center for Health Research, Patient Safety Action Network, and USA Patient Network in response to the Medical Device User Fees Amendments (MDUFA) VI Stakeholders Process and Commitment Letter
August 7, 2026. In response to a request for public comments by the FDA on proposed recommendations for reauthorizing the Medical Device User Fee Amendments (MDUFA) VI for fiscal years 2028–2032, four members of the Patient, Consumer, and Public Health Coalition that attended the FDA Stakeholders meeting urged the FDA to strengthen patient safety with resources for post-market surveillance, safety metrics, ensuring that studies represent all patients, and ensure FDA staff can focus their resources on rigorous review of medical devices.