Three OTC COVID-19 Tests Win FDA Clearance After Template Updates
Access Bio’s CareStart COVID-19 Antigen test gives results within 10 minutes, Becton, Dickinson’s BD Veritor within 15 minutes and InBios International’s SCoV-2 Ag Detect within 20 minutes. All three hold emergency use authorizations.
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The White House also announced it would double commitment it made in September for number of OTC test kits to be distributed free by community groups from 25m kits to 50m and would add rural clinics to the program.
A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.
The US agency made changes to two of its emergency use authorization templates “to support authorization of more COVID-19 tests” for over-the-counter use and to offer “flexible study recommendations.”