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 ...
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 FDA has also authorized 1221 revisions to EUA authorizations. 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. 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. The data from [MakeMyTestCount.org](https://makemytestcount.org/) [External Link Disclaimer](http://www.fda.gov/about-fda/website-policies/website-disclaimer)can help public health departments know how fast the virus is spreading. [step-by-step guide](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/understanding-home-otc-covid-19-antigen-diagnostic-test-results#Guide)to include information about reporting your over-the-counter (OTC) at-home COVID-19 test result to [MakeMyTestCount.org](https://makemytestcount.org/) [External Link Disclaimer](http://www.fda.gov/about-fda/website-policies/website-disclaimer).