diagnostic

FDA updates its FAQs on COVID-19 testing and approves new EUAs

April 22, 2020

McDermott+Consulting

The FDA continues to update its FAQs on COVID-19 testing.

As of April 21, 2020, the FDA had 43 EUAs for test kits manufacturers and commercial laboratories. In addition, the FDA granted EUAs for 17 high complexity molecular-based laboratory developed tests.

Finally, on April 21, 2020, the FDA authorized its first diagnostic test with an at-home collection option for COVID-19.

FAQs on Diagnostic Testing for SARS-CoV-2

Emergency Use Authorizations

Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection

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