CDRH Proposes Postmarket Surveillance Improvements

December 1, 2012 | Evaluations & Guidance


In September, FDA’s Center for Devices and Radiological Health (CDRH) issued a draft report proposing a plan to improve its postmarket surveillance of medical devices. This plan was developed at least partly in response to the July 2011 report from the Institute of Medicine titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” which included recommendations that FDA devise a comprehensive strategy for postmarket surveillance.

Currently, FDA’s postmarket surveillance efforts include the Medical Device Reporting (MDR) system, the Medical Product Surveillance Network (MedSun), postapproval and postmarket studies, and discretionary research undertaken by the agency about device performance, safety, and benefits and risks. However, recent reports of notable medical device failures have called into question...

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