“Expanding America’s testing capabilities is the result of partnership and ingenuity between the federal government, private sector and academia. Today’s authorization is another achievement of that work. Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly,” said FDA Commissioner Stephen M. Hahn, M.D.
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.
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