Author name: PCeditor

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.

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 Read More »

Public Comment of Members of the Patient, Consumer, and Public Health Coalition on National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR)

Members of the Patient, Consumer, and Public Health Coalition urge CMS to reject a National Coverage Determination for TAVR in asymptomatic patients, citing insufficient evidence of benefit for Medicare beneficiaries. The comment raises concerns about patient safety, trial limitations, valve durability, and responsible use of Medicare resources.

Public Comment of Members of the Patient, Consumer, and Public Health Coalition on National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR) Read More »

Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting

October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.

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