MAUDE Database Upgrade, Real-World Trials Advocated By FDA Task Force
This article was originally published in The Gray Sheet
Executive Summary
FDA's Center for Devices and Radiological Health needs to step up its efforts to improve the analytical features of the Manufacturer and User Device Experience (MAUDE) database to allow for management of spontaneous adverse event reports, FDA's Task Force on Risk Management recommended in its report to the commissioner, released May 10.