Zdrowie i gospodarka · 6.03.2020

Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under the Clinical Laboratory Improvement Amendments Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "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." On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy regarding laboratories using tests they develop and validate before FDA has issued an Emergency Use Authorization (EUA) for their test in order to achieve more rapid testing capacity in the United States. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.