Author name: PCeditor

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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Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.

Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission Read More »