USA – FDA smooths the path for COVID screening tests

At the one-year mark of the public health emergency of the pandemic, the US Food and Drug Administration (FDA) is providing a smoother road to the authorization of COVID-19 tests to screen asymptomatic individuals.
 
On Tuesday, FDA issued a fact sheet for those who are interested in setting up screening programs, an update to its FAQ document about COVID-19 testing, and a supplemental template for emergency use authorization (EUA) for COVID-19 diagnostic tests.
 
By issuing the supplemental template, FDA is offering “a streamlined path to emergency use authorization for these important screening tools,” according to a joint statement from Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health (CDRH), and Timothy Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics at CDRH…