1. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019 Subject(s): Clinical Trials as TopicDevice ApprovalData CollectionEthics Committees, ResearchInformed ConsentSingle-Case Studies as TopicHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.