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FDA relaxes regulations around Covid-19 diagnostics

March 17, 2020

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The US Food and Drug Administration (FDA) has relaxed the regulations around diagnostics for Covid-19 to expedite the availability of testing.

Tests developed and used by laboratories across the country can now be authorised by state Departments of Health without direct engagement from the FDA. The developers will not need to pursue an Emergency Use Authorisation (EUA) with the FDA to have their assays approved.

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