FDA Coronavirus (COVID-19) Update: July 16th, 2020

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:

Today, the Food and Drug Administration (FDA) updated its Frequently Asked Questions on Testing for SARS-CoV-2.

The revised FAQs now include a list of laboratories that have been removed from the list of laboratories that had notified FDA that they had developed and validated diagnostic tests as set forth in Section IV.A of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) — titled “Laboratories Certified under CLIA that Meet the CLIA Regulatory Requirements to Perform High Complexity Testing Using Their Validated Diagnostic Tests Prior to EUA Submission.”

Any laboratory on this list has been removed from the notification list because FDA has determined that there are significant problems with its test that cannot be, or have not been, addressed in a timely manner and should no longer be used.

Testing updates:

To date, the FDA has currently authorized 179 tests under EUAs; these include 148 molecular tests, 29 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.