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.
2. Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019 Subject(s): Guidelines as TopicConsensusDevice ApprovalDrug ApprovalGovernment AgenciesVoluntary ProgramsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.Center for Biologics Evaluation and Research (U.S.)
