Silver Spring, MD – The U.S. Food and Drug Administration has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
FDA created a new website section about COVID-19 Coronavirus for people with cancer and health care professionals to highlight FDA resources and how FDA is working diligently to meet the needs of this vulnerable community during this critical time.
The FDA updated its Frequently Asked Questions (FAQs) on Testing for SARS-CoV-2.
The revised FAQs now include a list of commercial manufacturers of diagnostic tests that had previously provided notification to FDA under the policy outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests, but that have now been removed from that notification list and should no longer be offering that test.
As noted in the guidance, if an Emergency Use Authorization (EUA) request is not submitted by a commercial manufacturer of a diagnostic test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, the FDA intends to remove the manufacturer and test from the notification list.
Testing updates:
To date, the FDA has currently authorized 187 tests under EUAs; these include 154 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.
