1. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017 Subject(s): Device ApprovalPapillomavirus Infections -- diagnosisReagent Kits, Diagnostic -- standardsCervix Uteri -- cytologyCervix Uteri -- virologyEquipment FailureEquipment SafetyGenotyping Techniques -- standardsMass ScreeningPapillomaviridae -- classificationPapillomaviridae -- geneticsQuality ControlReference StandardsReproducibility of ResultsResearch DesignSpecimen HandlingHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
