FDA -- Food and Drug Administration Office -- Immediate Release: October 04, 2021
Statement From:Jeffrey E. Shuren, MD, JD
Director - CDRH Offices: Office of the Center Director
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers.
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.
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.
Most antigen tests for at-home use are authorized for serial testing, or testing the same individual more than once within a few days. These authorizations followed the announcement of a streamlined approach to help facilitate the authorization of rapid tests for use with serial testing programs, which has increased consumer access to testing. Notably, based on the data provided for asymptomatic individuals, the ACON Laboratories Flowflex COVID-19 Home Test does not require serial testing. Today’s authorization will facilitate even greater access and testing capacity.
The FDA wants to remind patients that all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not rule out a COVID-19 infection.
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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.