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FDA To Issue Final Device Post-Market Surveillance Plan In February

The device center plans to publish the final version of its national device post-market surveillance strategy and select a third-party group to run its MDEpiNet public-private partnership by the end of February.

The device center is moving full speed ahead with plans to publish the final version of its national device post-market strategy by late February or early March, after receiving positive feedback on the proposed plan last year. The center will also choose an outside group to run its nascent Medical Device Epidemiology Network.

CDRH released its proposed post-market strategy last September with the goal of creating a system that could quickly identify poorly performing devices and disseminate information about real-world device performance. The plan includes establishing a unique device identification system; promoting the development of national and international registries; modernizing adverse event reporting; and developing new models for evidence generation, synthesis and appraisal

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