MobiHealth News March 18, 2021
Mallory Hackett

The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.

This week, the Food and Drug Administration shared that it will allow marketing for some COVID-19 screening tests before their effectiveness is studied in asymptomatic individuals.

Test developers seeking this over-the-counter authorization can apply using a template provided by the FDA to share data on who the test is intended for and how well the test works, and provide instructions for its use.

Authorizations are available for developers of tests intended to be used in serial screening programs or for serial at-home use to detect COVID-19 in asymptomatic people. This includes tests conducted in any location, including in a laboratory, at the point-of-care, in...

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Topics: FDA, Govt Agencies, Healthcare System, Home, Patient / Consumer, Public Health / COVID
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