Statement from FDA for Devices and Radiological Health, on FDA’s updates to Medical Device Safety A
date:Nov 21, 2018
s the multi-stakeholder effort to establish the new national system for gathering real world evidence (NEST). Based on our early activities, we have evidence that NEST will help improve the breadth and quality of RWE we can access and analyze.

Were now committing new resources to NEST to advance a more rapid build-out of this system.

In some cases, we already are receiving clinical evidence more quickly and more efficiently and are answering post-market questions we would not have been able to

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