The U.S. Food and Drug Administration (FDA) is providing further guidance and a smoother path for COVID-19 screening tests, specifically for asymptomatic patients. Part of this process includes the release of a fact sheet for those interested in organizing screening programs, as well as a supplemental template for emergency use authorization (EUA) COVID-19 diagnostics, and updating the FDA FAQ document on COVID-19 testing. In a joint statement from Timothy Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics at CDRH and Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health (CDRH), the supplemental template offers “a streamlined path to emergency use authorization for these important screening tools.”

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