FDA press releases and official announcements

FDA Authorizes First Over-the-Counter COVID-19 and Flu Test on Monday

Oct 8, 2024, 04:23 PM

The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the first over-the-counter combination COVID-19 and flu test outside of emergency use on Monday. This test, which uses a nasal swab sample, is intended for individuals experiencing respiratory symptoms and can be used at home to deliver results for both COVID-19 and flu. This authorization marks a significant step as it joins other over-the-counter COVID-19/flu tests that were previously available only under emergency use authorization.