FDA offers plan to improve post-market surveillance
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. Earlier this summer, the FDA issued its longawaited 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.