The U.S. Food and Drug Administration said in a new report that it plans to improve its post-market surveillance system for medical devices, in part by establishing a unique device identification system. The FDA's Center for Devices and Radiological Health proposed four initiatives to improve its post-market surveillance of devices: establishing a UDI system that can integrate with electronic health records; promoting the development of national and international registries for certain devices; modernizing adverse-event reporting and analysis; and developing new methods for evidence generation, synthesis and appraisal. Some of the proposed actions are in progress.
Late News: FDA offers plan to improve post-market surveillance
Earlier this summer, the FDA issued its long-awaited proposed rule on the UDI system, which will require manufacturers to begin marking the label and packaging of high-risk devices with unique identifiers within one year of the final rule taking effect. Last year, the Institute of Medicine recommended that the FDA develop a post-market surveillance strategy that will better use post-market performance data of devices. The FDA plans to hold four public meetings on the proposed initiatives this month and is also accepting comments online.
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