FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process

January 15, 2009 The Government Accountability Office (GAO) reviewed the Food and Drug Administration's practices regarding high-risk medical devices. The GAO was concerned about devices, such as electroconvulsive therapy (ECT) devices that have been classified as high-risk for a long period of time without review. ECT device manufacturers have never been required to seek premarket approval or demonstrate proof of efficacy for ECT because the devices were among those in use before 1976 and had received grandfathered approval through the FDA’s 510(k) process when the Medical Devices Amendments went into effect that year. The GAO . . .