1. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017 Subject(s): Equipment and SuppliesEquipment SafetyEvidence-Based MedicineProduct Surveillance, PostmarketingData CollectionData Interpretation, StatisticalDecision MakingDevice ApprovalQuality ControlHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, December 5, 2017 Subject(s): Device ApprovalEquipment and SuppliesInsurance CoverageMedicare -- economicsTherapies, InvestigationalHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.Centers for Medicare & Medicaid Services (U.S.)