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Coronavirus (COVID-19) Update: Daily Roundup September 8, 2020

For Immediate Release:

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

  • The FDA has deactivated the FDA registration for 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations.  Of these, 131 establishments list devices that are essential to the COVID-19 pandemic response.  
  • Testing updates:
    • To date, the FDA has currently authorized 243 tests under EUAs; these include 195 molecular tests, 44 antibody tests, and 4 antigen tests.
       

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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