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. Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2023 Subject(s): Data CollectionDevice ApprovalGovernment RegulationMedical Device LegislationUnited StatesUnited States.United States.
