FDA News Release
Coronavirus (COVID-19) Update: November 12, 2021
- 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:
- On November 9, 2021, the FDA posted an updated Molecular and Antigen Home Use Test Template intended to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes for COVID-19 tests. The template is intended to help test developers provide validation data and other information to the FDA. Developers can use alternative approaches and can discuss them with the FDA.
- Testing updates:
- As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (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 home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 10 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 18 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 682 revisions to test 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.
- Jim McKinney