Silver Spring, MD – The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Rat’s Army for selling unapproved products with fraudulent COVID-19 Coronavirus claims.
The company sells “VIRUS BIOSHIELD” with misleading claims that the product can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people. Consumers concerned about COVID-19 should consult with their health care provider.
On December 2nd, the FDA updated the SARS CoV-2 reference panel comparative data on our website to reflect the latest information. The FDA SARS-CoV-2 reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes.
The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2.The FDA provided the panel, comprised of standardized samples, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their emergency use authorization (EUA).
Testing update:
As of December 1st, 295 tests are authorized by FDA under EUAs; these include 227 molecular tests, 61 antibody tests, and 7 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.
