chapter  18
20 Pages

Clinical Studies for Medical Devices

Clinical studies, once rare for devices other than Class III devices, have become much more frequently required and performed. Since 1991, the U.S. Food and Drug Administration, Ofce of Device Evaluation (ODE) has taken actions for imposing more stringent requirements on clinical studies used to support device Premarket Approval (PMA) applications. Clinical studies are also being required more often to support performance claims in 510(k) premarket notications. In 2010, O’Flaherty presented an excellent review of modern device clinical trial requirements. The ODE focus on requiring carefully designed clinical trials is based, in part, on the Final Report of the Committee for Clinical Review, also known as the Temple Report.