1. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018 Subject(s): Clinical Trials as TopicConsensusDevice ApprovalEquipment and Supplies -- standardsVoluntary ProgramsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
