diagnostic

FDA Posts a Number of New Items Related to Coronavirus

March 02, 2020

McDermott+Consulting

On February 29, 2020, the FDA issued a new guidance document (immediately in effect) on its policy for diagnostic testing in laboratories certified to perform high complexity testing under CLIA prior to Emergency Use Authorization (EUA) for Coronavirus Disease-2019 (COVID-19) during the public health emergency.

  • The FDA held a webinar on March 2, 2020 to discuss this policy with and answer questions from interested stakeholders.

On February 29, 2020, the FDA also issued an EUA to authorize the emergency use of Wadsworth Center, New York State Department of Public Health’s New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet CDC COVID-19 clinical and/or epidemiological criteria.

Guidance Document

Emergency Use Authorizations

Webinar Slides

 

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