Fierce Biotech November 10, 2023
No, you didn’t set your clocks too far back for the end of daylight saving time. This week, the FDA granted its first full, bona fide clearance to an over-the-counter home antigen test for COVID-19, and its first to carry an official 510(k) for use in children under age 18.
Since 2020, the agency has granted emergency use authorizations to dozens of rapid, antigen-based coronavirus tests and hundreds of lab-based molecular diagnostics under its pandemic-era authorities.
And, while the U.S. government’s public health emergency declaration expired this past May, many EUAs still remain in effect. In this specific category of at-home, OTC tests, the agency currently lists 37 products with active green lights.
The Flowflex COVID-19 antigen home test, developed...
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