- 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:
- The FDA updated the Antigen Template for Test Developers. This template provides the FDA’s current recommendations concerning data and information that should be submitted to the FDA in support of an EUA request for a SARS-CoV-2 antigen test. Today’s update adds recommendations regarding studies to support claims for screening asymptomatic individuals and multiplexed antigen tests. The template reflects the FDA’s current thinking on the topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The FDA is open to alternative approaches.
- Testing updates:
- As of today, 284 tests are authorized by FDA under EUAs; these include 221 molecular tests, 56 antibody tests, and 7 antigen tests.
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.