1. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019 Subject(s): Device ApprovalEquipment and Supplies -- classificationGastroenterology -- instrumentationGynecologyObstetrics -- instrumentationOtolaryngology -- instrumentationPhysical and Rehabilitation Medicine -- instrumentationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
