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