FDA authorizes first at-home COVID-19 test using traditional review pathway

The Food and Drug Administration authorized for marketing the first at-home over-the-counter test for COVID-19 using a traditional premarket review pathway rather than emergency use authorities. The Cue COVID-19 Molecular Test detects SARS-CoV-2 in nasal swabs from adults with symptoms of upper respiratory infection. Subsequent devices of the same type with the same intended use that demonstrate substantial equivalence may now use the agency’s 510(k) pathway to obtain clearance, FDA said. 
  
“The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”