Diagnostic testing is one of the most critical responses that the U.S. Food and Drug Administration (FDA) is pushing in order to combat the global spread of the coronavirus. Eight months after the start of the outbreak, the FDA has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home. This new technology will provide rapid results within real time to ensure the patient will be able to self-isolate and seek additional care from their health care provider as quickly and efficiently as possible.
“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
The FDA, an agency within the U.S. Department of Health and Human Services, is continuing its public health commitment by assuring the safety, effectiveness, and security of new approaches to make these vital tests available for more Americans.