At-Home Coronavirus Test Makers Get New Guidance From FDA

July 29, 2020, 5:54 PM UTC

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, ...

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