- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- As part of the FDA’s effort to protect consumers, on Sept. 28, the agency issued a warning letter to Strategia Project Management, Inc. for selling an unapproved product with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 414 tests and sample collection devices are authorized by the FDA under emergency use authorizations (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 home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, eight 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 641 revisions to EUA authorizations.
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.