Today, the U.S. Food and Drug Administration is taking several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers and emergency rooms without having to be sent to a central lab for testing.
“In addition to vaccination efforts, testing remains a cornerstone of the national response to the pandemic and plays a central role in helping Americans get back to work, school and other important activities, particularly as the holiday season approaches. The FDA remains committed to helping to increase the availability of tests that will have the biggest impact on the nation’s ongoing COVID-19 testing needs, such as at-home and point-of-care diagnostic tests that can be produced in high volumes,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “By focusing our review on these types of tests, and helping to ensure that available tests have appropriate oversight, we can better respond to the pandemic as the nation’s testing needs continue to evolve.”
To date, the FDA has authorized over 420 tests and sample collection devices that provide a wide array of test options. Since the start of the pandemic, the FDA has adapted its regulatory approach to address the public’s testing needs and has been...
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