FDA authorizes OTC COVID tests for home use

In total, the FDA has authorized three tests with serial screening claims (testing asymptomatic individuals multiple times on a routine basis)…

These tests had been previously authorized by the agency (some under different names) to test those with COVID-19 symptoms, but the actions this week authorize testing of asymptomatic individuals when used for serial testing.

These authorizations follow the agency’s multiple steps to streamline the process for test developers interested in authorization for screening with serial testing to increase consumer access to testing, as well as information the FDA has issued to help schools, workplaces, communities, and others establish screening programs.