diagnostic

FDA took two additional steps in response to the coronavirus (COVID-19) outbreak

March 13, 2020

McDermott+Consulting

On March 12, 2020, the FDA took two additional steps to address the coronavirus (COVID-19) outbreak.

First, the FDA issued enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the NYSDOH.

Second, the agency announced a third Emergency Use Authorization granted for a diagnostic test for COVID-19.

Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic

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