- 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:
- Today, the FDA took steps to further facilitate the authorization of tests for pooling specimens from asymptomatic individuals in serial testing programs. The FDA issued a pooling and serial testing amendment for many molecular diagnostic COVID-19 tests that had received an emergency use authorization (EUA) for testing individual samples. The amendment requires test developers to submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. It further supports the expansion of COVID-19 testing in schools, workplaces, communities, and other entities looking to establish serial testing programs for people without symptoms and with no known suspected exposure to COVID-19.
- Testing updates:
- As of today, 367 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 269 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 23 antigen tests. There are 49 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests.
- The FDA has authorized 8 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 462 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.
- Abby Capobianco