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Coronavirus (COVID-19) Update: 10/15/21

For Immediate Release:

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

  • On Oct. 12, 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 tests during the public health emergency. The assessment was conducted by Booz Allen Hamilton, an independent, third-party contractor. This assessment focuses on how CDRH prioritized processing of EUA requests, review times, accuracy and reliability of COVID-19 tests, a comparison to prior public health emergencies and requestors’ perspectives. The web posting includes Booz Allen Hamilton’s Emergency Use Authorization Assessment and recommendations and CDRH’s perspectives and next steps. 
  • 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.
  • Testing updates: 
    • 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.
       

Related Information

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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.


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