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. Fostering medical device improvement: FDA activities and engagement with the voluntary improvement program : guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, September 15, 2023 Subject(s): Government RegulationMedical Device LegislationQuality ImprovementVoluntary ProgramsUnited States
3. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023 Subject(s): Drug IndustryGovernment RegulationReference StandardsRegenerative Medicine -- legislation & jurisprudenceRegenerative Medicine -- standardsVoluntary ProgramsUnited StatesCenter for Biologics Evaluation and Research (U.S.)
