diagnostic

FDA updates its FAQ on COVID-19 testing and gives EUA to additional tests

March 25, 2020

McDermott+Consulting

On March 23, FDA updated its FAQ regarding specimen collection for COVID-19 testing. Based on the clinical data available, FDA believes that, for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This change would allow for specimen collection that is more comfortable for the patients, could enable self-collection of the specimen at the collection site, and could be performed with a type of swab that is more readily available, addressing supply concerns.

FDA also continues to issue additional Emergency Use Authorizations for diagnostic tests for COVID-19. As of the morning of March 25, thirteen tests now have received EUAs. Under its laboratory developed test policy for COVID-19, the FDA has been notified by 65 laboratories with tests.

FAQs on Diagnostic Testing for SARS-CoV-2

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

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