The FDA said March 16 it will allow manufacturers of COVID-19 tests to market tests for at-home or point-of-care use without studying how well they work in asymptomatic people.
The agency said its goal is to make it easier to screen people returning to work and school.
"We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing," Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics, said in a news release.
Some rapid tests are less accurate in asymptomatic people, Politico reported. But the FDA's updated policy takes into account that repeated testing for screening purposes can improve the overall accuracy of test results.
The FDA said it will allow companies to apply to market over-the-counter tests for at-home or point-of-care use if they can provide evidence the test performs well in people with symptoms of COVID-19 and that repeated testing can help mitigate false results.
Read the FDA's full news release here.