1. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 30, 2017 Subject(s): ClassificationDevice Approval -- standardsEquipment and Supplies -- classificationEquipment Safety -- classificationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019 Subject(s): Cost-Benefit AnalysisDevice ApprovalEquipment and Supplies -- classificationEquipment Safety -- classificationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
