.US_FDA has authorized two new over-the-counter at-home COVID19 tests. These tests will bring tens of millions of new tests per month to the U.S. Learn more:
, have received emergency use authorization by the Food and Drug Administration after being evaluated through the Administration’s new accelerated pathway to support FDA review of tests with potential for large-scale manufacturing that the Department of Health and Human Services These quick authorizations are thanks to collaboration between the FDA and the National Institutes of Health Rapid Acceleration of Diagnostics Technology program.
In late October, HHS announced the Administration would invest $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with FDA. This new Independent Test Assessment Program is helping identify manufacturers of high-quality tests and encouraging them to bring those tests to the U.S. market, increasing options for people and overall supply and potentially lowering costs.
"This program is incredibly beneficial to increasing access to rapid tests by quickly and consistently gathering the critical data companies need to request EUA and subsequently enter the U.S. market once authorized," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.
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