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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
that weve laid in recent years to become consistently first. Were evolving beyond our current post-market surveillance system -- which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting. Were moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information. We have long recognized the systemic weaknesses of the passive system a challenge faced by other countries and we prioriti

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