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Leveraging Registries: A Next Step In National Post-Market Plan

FDA is making a major push as part of its new post-market surveillance strategy to make better use of existing national patient registries, while avoiding imposition of additional mandatory device registries.

FDA is making a major push as part of its new post-market surveillance strategy to make better use of existing national patient registries to more quickly identify poorly performing devices, understand real-world clinical benefits and eventually use the data to create innovative new devices.

Promoting the development of national and international registries is one of the four approaches outlined in FDA’s national post-market surveillance strategy issued earlier this month. (See Also see...

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