Coronavirus Update: FDA gives flexibility to New York State Department of Health, grants Roche EUA

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

Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19). First, the agency 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. Under NYSDOH’s approach, laboratories will provide validation data to NYSDOH within 15 days in lieu of pursuing an Emergency Use Authorization (EUA) with FDA. Second, the FDA authorized the Roche cobas SARS-CoV-2 Test, the third Emergency Use Authorization (EUA) granted for a diagnostic test during the COVID-19 outbreak. “These actions today show our commitment to working around the clock to help expedite the availability of tests. This NYSDOH action shows the FDA’s extreme flexibility and adaptability during times of public health emergencies,” said FDA Commissioner Stephen M. Hahn, M.D. “As a practical matter, what this action means is that labs, authorized by ...

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