FDA Open To Home COVID-19 Testing With Caveats, OIVD’s Stenzel Says

 
• By Sue Darcey

The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health.

Sample blood test of Coronavirus (Covid-19) on hand with black glove, Coronavirus Covid 19 infected blood sample in sample tube in hand of scientist doctor biohazard protection coronavirus, positive

[Editor’s note: This article was updated on 7 April to clarify the regulatory status of the Becton Dickinson/BioMedomics serology COVID-19 test.]

The US Food and Drug Administration hopes to give the green light soon to home-use testing for coronavirus, as long as certain conditions are met, the director of the agency’s...

More from Regulation

More from Policy & Regulation