FDA creates template for emergency clearance of at-home COVID-19 tests

2020 05 29 19 30 2147 Emergency Sign

The U.S. Food and Drug Administration (FDA) has created a template to clarify and smooth the way toward obtaining emergency use authorization (EUA) for at-home sample collection kits for COVID-19.

While there are authorized COVID-19 tests for use with at-home collection of samples that may be sent to a lab for processing and test reporting, there are currently no tests authorized to be used completely at home. All tests that have received an EUA, including any authorizations for home collection of a specimen, can be found on the FDA's website page on EUAs.

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