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:

  • As part of the FDA’s efforts to protect consumers, the agency sent a warning letter on Sept. 28 to: Strategy Project Management, Inc. for selling an unapproved product with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult their health insurer.
  • Testing updates:
    • As of today, 414 tests and sample collection devices have been approved by the FDA under emergency approvals (EUAs). These include 289 molecular tests and sample collection devices, 89 antibody and other immune response tests, and 36 antigen tests. There are 65 molecular authorizations and one antibody authorization that can be used with self-collected samples. There is one prescription molecular home test, three prescription home antigen tests, eight home antigen over-the-counter (OTC) tests, and two OTC home molecular tests.
    • The FDA has approved 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also approved 641 revisions to 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.