Healthcare

FDA approves first over-the-counter at-home coronavirus test

By David Hogberg
Published December 15, 2020 5:30pm ET
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FDA approves first over-the-counter at-home coronavirus test
President Trump signed into law the FDA Reauthorization Act of 2017 on Friday. It reauthorizes a program in which drug and device makers pay the FDA a fee for every new product application, and the agency uses that money to hire more people and speed up approvals. (AP Photo/Andrew Harnik, File) | Andrew Harnik

The Food and Drug Administration has approved the first over-the-counter diagnostic test for COVID-19.

The FDA issued an emergency use authorization Tuesday for the Ellume COVID-19 Home Test. Ellume Health, a developer of diagnostic medical tests based in Australia, says the test can be used anywhere and returns results in 15 minutes.

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COVID-19 FDA Regulations