For immediate release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response to the COVID-19 pandemic:

  • On Monday, November 15, 2021, the FDA took several important steps to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable tests, especially COVID-19 diagnostic tests that can be performed at home or in places such as doctors’ surgeries, hospitals, urgent care centers and emergency rooms without having to be sent to a central office. . lab for testing.
    The FDA:
  • Testing updates:
    • As of today, 422 tests and sample collection devices have been approved by the FDA under emergency approvals (EUAs). These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests, and 39 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with self-collected samples. There is one EUA for home molecular prescription testing, three EUAs for home prescription antigen testing, 10 EUAs for over-the-counter (OTC) antigen self-testing and three EUAs for OTC home molecular testing.
    • The FDA has approved 19 antigen tests and nine molecular tests for serial screening programs. The FDA has also approved 685 revisions to test EUA authorizations.

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The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.