Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
A new FDA Voices, tilted FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability, describes how FDA has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.
The agency engaged with the lab and commercial manufacturer communities even before any cases of COVID-19 Coronavirus were diagnosed in the United States, working with more than 500 developers since January.
FDA has been working around the clock to issue more than 180 Emergency Use Authorizations (EUAs) tests, including molecular, serology, antigen, and tests with at-home-specimen-collection indications.
Today, FDA delivered written testimony to the Senate Subcommittee on Manufacturing, Trade, and Consumer Protection. The statement, titled Protecting Americans from COVID-19 Coronavirus Scams, was by Catherine Hermsen, FDA’s Assistant Commissioner, Office of Criminal Investigations, Office of Regulatory Affairs.
Testing updates:
To date, the FDA has currently authorized 186 tests under EUAs; these include 153 molecular tests, 31 antibody tests, and 2 antigen tests.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.
