drew attention from members of Congress in March for entering the market for coronavirus test kits in March without F.D.A. approval.
Everlywell, which had promoted its at-home kit as a consumer product, said in a statement at the time that it had not sold any of the kits to consumers, but was providing the test materials “at cost to hospitals and health care organizations who can commit to providing the test for free to their workers and patients.”
The F.D.A.’s announcement on Saturday follows other recent emergency use authorizations for coronavirus testing kits that also permit individuals to take samples at home. One, sold by LabCorp, also uses a nasal swab to collect a sample, which is then sent to the lab. The other, developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs, is for collecting a saliva sample.