Statement from FDA for Devices and Radiological Health, on FDA’s updates to Medical Device Safety A
date:Nov 21, 2018
zed this area for regulatory reform efforts.

In 2012, FDA announced a vision for the medical device program that reflected the importance of safety, by looking to establish a U.S. post-market surveillance that quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearances.

Soon thereafter, we issued a strategy for establishing a national medical device post-market surveillance system that employs active surveillance.

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