Statement from FDA for Devices and Radiological Health, on FDA’s updates to Medical Device Safety A
date:Nov 21, 2018
t registries also utilize UDIs to help quickly identify safety signals tracked to specific devices.

Weve also taken steps to advance the use of real-world evidence (RWE) in pre- and post-market decision-making. We believe that including the device identifier in electronic data more broadly, including in insurance claims, will advance FDAs efforts to leverage real-world data to support the development of more effective post-market surveillance tools. A key element of implementing this strategy i

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