At-Home Coronavirus Test Makers Get New Guidance From FDA

July 29, 2020, 5:54 PM

Companies making at-home Covid-19 tests got new directions from the FDA Wednesday on submitting their tests for approval under emergency use conditions.

The Food and Drug Administration’s template is intended to help get simple at-home or over-the-counter diagnostic tests on the market, comparable to home pregnancy tests, according to FDA Commissioner Stephen M. Hahn. That could ease the long lines and lengthy waits in some areas for Covid-19 tests and results.

“We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available,” Hahn said.

“These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”

The recommendations include examples of when a sample is to be collected and analyzed and when results are to be returned without sending a sample to a lab for analysis.

The template also advises developers on how to determine whether a test should be made available over-the-counter without a prescription and outlines the recommended performance for these types of test.

To contact the reporter on this story: Ayanna Alexander in Washington at aalexander@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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