Federal Register Notice: FDA is making available a guidance entitled Design Considerations for Pivotal Clinical Investigations for Medical Devices. It is intended to provide guidance to those who design clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. It describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. To download this guidance, click here. To view this notice, click here.