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.
FDA approval of TTVR was premature and the data are inadequate to support the safety and effectiveness of TTVR for the Medicare population. The Patient, Consumer, and Public Health Coalition urges CMS to conduct a thorough MEDCAC review prior to making a coverage decision.
Coalition Public Comment to CMS on Transcatheter Tricuspid Valve Replacement Coverage Read More »
The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
Coalition follow-up letter to FDA regarding FDA overruling their own scientists Read More »
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.
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.
The Coalition supported the FDA proposed rule on lab-developed tests (LDTs) to diagnose diseases and genetic issues, with the exception of FDA’s proposed increased use of third-party reviewers.
Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests Read More »
The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.
Coalition Letter to FDA regarding consumer representatives in Advisory Committees Read More »
The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings Read More »
We support this CT quality measure because it establishes a floor and a ceiling to provide an optimal level of radiation exposure for imaging for numerous different conditions, without reducing the diagnostic benefits of those scans.
We are writing to enthusiastically support the CT quality measures developed by researchers at the University of California, San Francisco: Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults.
Coalition Letter to MAP workgroups on CT quality measures Read More »
We request that the FDA reverse its policy to exempt many implantable medical devices from directly displaying a UDI number on the implant, and to institute a policy of improved record keeping and record retention.
Coalition Letter to FDA Regarding UDI Numbers on Medical Devices Read More »
