Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency | NLM

Disaster Information Management Research Center | NLM

Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency

02/29/2020 12:00 AM EST

Source: U.S. Food and Drug Administration (FDA). Published: 2/29/2020. This eight-page guidance provides a policy for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) prior to issuance of emergency use authorizations (EUA) for such tests. It describes an accelerated policy enabling laboratories to use tests they develop faster in order to achieve more rapid testing capacity in the United States. (PDF)