1. Technical considerations for medical devices with physiologic closed-loop control technology: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2023 Subject(s): Equipment DesignEquipment SafetyGovernment RegulationMedical Device LegislationMonitoring, PhysiologicUnited 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
