Devices

More than 95% of medical devices on the market were not required to be proven safe or effective. Less than 5% are required to be studied in clinical trials. Our goal is to improve the safety and effectiveness of all medical devices sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks of each device.

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 »

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 »

Coalition comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.

Coalition comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions Read More »