Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., July 15, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 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.

Additional Resources:

  • FAQs on Testing for SARS-CoV-2
  • Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
  • Coronavirus Disease 2019 (COVID-19)

Media Contact: 
Consumer Inquiries: 888-INFO-FDA

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.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

Cision View original content to download multimedia:

SOURCE U.S. Food and Drug Administration

XL subscribe to our newsletter banner

Get the latest news and advice on COVID-19, direct from the experts in your inbox. Join hundreds of thousands who trust experts by subscribing to our newsletter.

Send your news and stories to us or and WhatsApp: +447747873668.

Before you go...

Democratic norms are being stress-tested all over the world, and the past few years have thrown up all kinds of questions we didn't know needed clarifying – how long is too long for a parliamentary prorogation? How far should politicians be allowed to intervene in court cases? To monitor these issues as closely as we have in the past we need your support, so please consider donating to The Climax News Room.