Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic.
On October 12th, the FDA posted information about an assessment of the Emergency Use Authorization (EUA) process that the FDA’s Center for Devices and Radiological Health (CDRH) implemented to help authorize COVID-19 Coronavirus tests during the public health emergency.
The Center for Food Safety and Applied Nutrition published a Constituent Update intended for food and agriculture workers/industry encouraging vaccination against influenza and COVID-19 Coronavirus.
As of today, 418 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests and 37 antigen tests.
There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, seven antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
The FDA has authorized 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 650 revisions to EUA authorizations.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.