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.
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.
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.
The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.
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.
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.
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.
FDA has been slow to recognize the full impact of BIA-ACL and needs to do more to protect women from it. The delayed intervention of the FDA and surgeons everywhere on this matter is too serious to ignore. For those women who were barely informed of these severe risks, it has had terrible and sometimes fatal consequences.
