U.S. Health and Human Services Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests | site |




(November 17, 2020) - - On November 17, 2020 the U.S. Department of Health and Human Services (HHS) published the following information:

On Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic at-home test, the Lucira COVID-19 All-In-One Test Kit, a molecular test that provides results in 30 minutes or less and is authorized for use by prescription only. HHS Secretary Alex Azar issued the following statement:

“Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options. The Trump Administration has built the world’s largest testing system, and we will continue supporting both the development and manufacturing of cutting-edge options to make COVID-19 testing even easier and more accessible for the American people.”