1. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017 Subject(s): Equipment and Supplies -- standardsEquipment Design -- standardsEquipment Safety -- standardsDevice ApprovalEquipment FailureInformation DisseminationRisk ManagementHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. 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.
