1. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019 Subject(s): Compassionate Use Trials -- standardsCost-Benefit AnalysisDevice Approval -- standardsEquipment and Supplies -- classificationUncertaintyData CollectionReagent Kits, DiagnosticResearch DesignSample SizeHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Humanitarian device exemption (HDE) program: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2019 Subject(s): Compassionate Use Trials -- standardsDevice Approval -- standardsCost-Benefit AnalysisHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
