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.

Letter to the FDA and Commissioner Hamburg in Support of the Filing of Premarket Approval for the Implantable Pacemaker Pulse Generator

April 28, 2022

We strongly support the FDA’s proposal to require the filing of a premarket approval application (PMA) for the implantable pacemaker pulse generator, a class III pre-amendments device. We agree with report on the 510(k) process’s recommendations 7-8, which state that the FDA should promptly call for PMA applications or reclassify the Class III devices that are still cleared by the 510(k) process.  The implantable pacemaker pulse generator is one of those Class III devices alluded to by GAO and IOM.

Comments of Members of the Patient, Consumer, and Public Health Coalition FDA’s Center for Devices and Radiological Health 510(k) Clearance Process: Recommendations Proposed in Institute of Medicine

April 28, 2022

We support the Institute of Medicine’s (IOM) efforts to strengthen the 510(k) clearance process for medical devices, but believe that the concerns expressed by the IOM regarding the lack of proof of safety and efficacy can be addressed by substantially improving 510(k) criteria, policies, and implementation. We strongly encourage CDRH to incorporate the concerns of the IOM report into substantial efforts to improve the 510(k) process, and to better ensure the safety and effectiveness of implanted medical devices by requiring that they all be reviewed through the PMA process instead.