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May 26, 2020 - Coronavirus (COVID-19), FDA, Drug & Medical Device, Product Liability, Emergency Use Authorization (EUA)

FDA Signals Flexibility with COVID-19 Tests

Using Waivers to Curb COVID-19 Legal Exposure

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy.

Consistent with this, FDA has taken various steps to accelerate the availability of testing, as we have previously reported. Notably, in its Policy for Diagnostic Tests for Coronavirus Disease-2019 (last updated May 11), FDA describes circumstances under which CLIA-certified laboratories that develop and validate tests for coronavirus can use the tests before the agency has completed review of the lab’s EUA.

Read more on MoFo Life Sciences.