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Coordinated Registries Network for Medical Device Evaluation Recommended

Monday, August 31, 2015   (0 Comments)
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A national coordinated registries network that monitors medical devices after they are made commercially available would make it easier for stakeholders to use data from disparate sources, according a new report commissioned by FDA

A Medical Device Registries Task Force was convened to help FDA's Center for Devices and Radiologic Health (CDRH) bolster post-market surveillance of medical devices - see Krucoff et al., Journal of the American Medical Association for a summary.

Information on medical devices can be found in registries, electronic health records, and claims data, but the recommendations call for aggregating it in a central location to make it easier for regulators, doctors and patients use it. The CRN also would provide device manufacturers with information from more diverse groups of patients exposed to devices in more diverse treatment settings, the report says.

The recommendations will be open for feedback for 60 days.

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