FDA announcements and press releases

FDA Authorizes First OTC COVID-19/Flu Test; Free At-Home Tests Available

Oct 8, 2024, 11:44 AM

The FDA has granted marketing authorization for the first over-the-counter COVID-19 and flu test that can be used without a prescription. This test, which uses a nasal swab sample, allows individuals experiencing respiratory symptoms to obtain at-home results for both COVID-19 and flu. This authorization marks a significant step as it is the first test of its kind to be available outside of emergency use authorization. The test is expected to be particularly useful for families as the flu season approaches. Additionally, households nationwide can now order four free at-home COVID-19 tests, which are capable of detecting current variants and can be used through at least the end of 2024. Healthcare professionals can join the next COCA Call on October 10, 2–3 p.m. ET, for updates on diagnostic testing and outpatient treatment for COVID-19 and flu, with continuing education offered.