May 15, 2020 -- The U.S. Food and Drug Administration (FDA) has released an updated guidance document on coronavirus testing for clinical laboratories and commercial manufacturers reflecting the fast-moving pandemic landscape.
The guidance document sets policy for test standards on an emergency basis; it takes effect immediately, though the agency is accepting comments from stakeholders. Guidance on the agency's policies for COVID-19 testing was initially published on February 29 and has now been revised three times.
The document sets out policies for accelerating development of lab tests through two different pathways, one of which entails an emergency use authorization (EUA) and the other of which does not. It also addresses specimen testing by labs for validation of commercial tests and policy on serology testing. Furthermore, the agency has provided templates for submissions of EUAs for three types of testing -- molecular, antigen, and serology -- in a bid to speed up the process.
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