The U.S. Food and Drug Administration on Monday gave authorization for emergency use of another COVID-19 at-home test consumers can get over the counter.
“Today’s 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. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022,” said the organization on Monday.
Since March 2020, the FDA has authorized more than 400 COVID-19 tests and sample collection devices, including authorizations for rapid, OTC at-home tests. 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.
“We believe at-home diagnostic tests play a critical role in the fight against COVID-19. We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans.”
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