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.
2. CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023 Subject(s): Drug IndustryGovernment RegulationQuality ControlReference StandardsUnited StatesUnited States. Food and Drug Administration
