Update: FDA Issues Emergency Use Authorization for First Coronavirus Diagnostic Panel

By MedTech Intelligence Staff

The agency is allowing the emergency use of a CDC 2019-nCoV real-time PCR panel.

Yesterday evening FDA released an update about an important milestone in response to the coronavirus outbreak. The agency issued an emergency use authorization to allow nationwide use of CDC’s 2019-nCoV Real-Time PCR Diagnostic Panel. Up until now, the test has only been used in CDC labs.

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA Commissioner Stephen M. Hahn, M.D in an agency news release. “Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible.”

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