1. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018 Subject(s): Databases, GeneticReagent Kits, Diagnostic -- standardsReproducibility of ResultsAccess to InformationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
