1. Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020 Subject(s): ElectrodesEquipment DesignEquipment SafetyElectrocardiographyUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.