Shuren: FDA Revisits Hospital Adverse Event Reporting, Plans Dec. 5 Meeting

FDA is looking into whether its adverse events reporting requirements for hospitals should be changed or eliminated in light of new reporting tools presented by unique device identifiers, device center chief Jeff Shuren revealed Monday (Oct. 24) in an FDA Voic e blog. The agency will hold a public meeting on Dec. 5 to discuss hospitals' role in generating data on medical devices coming after inspectors found some hospitals didn't notify FDA about deaths or serious injuries linked to devices...