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Statement from FDA for Devices and Radiological Health, on FDA’s updates to Medical Device Safety A
date:Nov 21, 2018
ents.

Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market. Even reasonably-sized premarket trials cannot be expected to reveal everything that could eventually become known about a novel medical device once its more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians.

Access to robust and timely data, including more extensive and informative post-ma

12/21 21:50