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

However, for NEST to become fully functional and fulfill its promise of helping to ensure safer devices for patients, additional resources are essential. Indeed, funding is the principal barrier to establishing this system. To bridge the gap, the Presidents budget for fiscal year 2019 includes a request for an additional $46 million for CDRH to support NEST, as well as to conduct FDA-sponsored post-market studies that address device-specific safety concerns. If this

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