ABSTRACT
Clinical studies, once rare for devices other than Class III devices, are becoming much more frequently required and performed. Since 1991, ODE has taken actions for imposing more stringent requirements on clinical studies used to support device PMA applications. Clinical studies are also being required more often to support performance claims in 510(k) premarket notifications. 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.
