1. Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020 Subject(s): Clinical Laboratory Techniques -- standardsDiagnostic ErrorsReagent Kits, Diagnostic -- standardsUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
