FDA Roundup: February 7, 2023

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Feb 07, 2023, 15:37 ET

SILVER SPRING, Md., Feb. 7, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Monday, the FDA updated its easy step-by-step guide to include information about reporting your over-the-counter (OTC) at-home COVID-19 test result to MakeMyTestCount.org. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. The data from MakeMyTestCount.org can help public health departments know how fast the virus is spreading. This valuable test data helps public health departments assess and modify their response to COVID-19 in their local communities, states or across the country. The MakeMyTestCount website is developed through the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Tech program and allows consumers to anonymously report the results of their OTC at-home COVID-19 test.
On Friday, the FDA cleared the BioFire SPOTFIRE Respiratory (R) Panel, an in vitro diagnostic test used for the simultaneous detection and identification of multiple respiratory viral and bacterial infections in individuals suspected of having COVID-19 or other respiratory tract infections. This test was reviewed through the Dual 510(k) and CLIA Waiver pathway, making it the first COVID-19 test to be cleared with a CLIA Waiver.
COVID-19 testing updates:

As of today, 440 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 296 molecular tests and sample collection devices, 85 antibody and other immune response tests, 58 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen OTC at-home tests, and four for molecular OTC at-home tests.
The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1221 revisions to EUA authorizations.

Additional Resources:

FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540
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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.

SOURCE U.S. Food and Drug Administration