The Food and Drug Administration wants to improve the way the regulatory agency works with hospitals to collect data regarding medical devices and adverse events.
According to Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, the FDA has several tools for monitoring medical devices after they are on the market—called postmarket surveillance—but they have inherent limitations.
“The most well-known of FDA’s postmarket surveillance tools is medical device reporting, which FDA requires from certain entities, including device manufacturers and device user facilities, such as hospitals,” Shuren writes in an October 24 blog.
