1. 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.
2. Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): Data CollectionDigital HealthEquipment DesignEquipment SafetyGovernment RegulationMedical Device LegislationRemote Sensing Technology -- standardsUnited States
