US FDA Targets Making More COVID-19 Tests Available OTC With EUA Template Changes
Agency changes two of its emergency use authorization templates “to support authorization of more COVID-19 tests” for OTC use and to offer “flexible study recommendations.”
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The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.
BD has EUA for Veritor At-Home COVID-19 rapid antigen test using smartphone vision technology to interpret and digitally display results. Researchers at biotech firms and medical schools measure advantages of at-home use of rapid antigen tests over quantitative real-time polymerase chain reaction tests.
Anytime COVID Test marketed home-use test without FDA approval or EUA and promoted it with an FDA logo and a “clinical trial number.” Warning letter says “your presentation conveys the misimpression that the product has been approved, cleared, authorized, endorsed or otherwise evaluated by FDA.”