Report Finds Problems With FDA Mandated Postapproval Device Studies

As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused...Click here to continue reading...
Source: CardioBrief - Category: Cardiology Authors: Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes devices FDA postapproval Source Type: blogs