1. 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.)
2. Clinical investigations for prostate tissue ablation devices: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, July 15, 2020 Subject(s): Clinical Studies as TopicHigh-Intensity Focused Ultrasound AblationProstate -- surgeryProstatic Neoplasms -- prevention & controlProstatic Neoplasms -- surgeryTherapies, InvestigationalUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
