FDA issues EUA for at-home COVID-19 test

Oct. 5, 2021

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test that can be used without a prescription.

Most antigen tests for at-home use are authorized for serial testing — or testing the same individual more than once within a few days. However, the ACON Laboratories Flowflex COVID-19 Home Test does not require serial testing.

The “authorization for the ACON Laboratories Flowflex COVID-19 Home Test should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks,” said Jeffrey E. Shuren, MD, JD, Director of the FDA’s Devices and Radiological Health.“The FDA considers at-home COVID-19 diagnostic tests to be a high priority and we have continued to prioritize their review given their public health importance.”

By the end of 2021, the manufacturer, based in San Diego, plans to produce more than 100 million tests per month, rising to 200 million per month by February 2022.

Since March 2020, the FDA said it has authorized more than 400 COVID-19 tests and sample collection devices, including authorizations for rapid, OTC at-home tests.

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