1. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018 Subject(s): Genetic TestingGerm-Line MutationDiagnostic Test ApprovalReagent Kits, Diagnostic -- standardsSequence Analysis, DNAGenomicsReproducibility of ResultsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022 Subject(s): Diagnostic Test ApprovalGovernment RegulationReagent Kits, DiagnosticUnited StatesUnited States. Food and Drug Administration
