FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports. The agency engaged with the lab and commercial manufacturer communities even before any cases of COVID-19 were diagnosed in the U.S., working with over 500 developers since January, and has been working around the clock to authorize over 180 Emergency Use Authorizations (EUAs) for tests, including molecular, serology, antigen, and tests with at-home specimen collection indications.  

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