FDA Coronavirus (COVID-19) Update: June 13th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) is continuing to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

This week, the FDA issued an Emergency Use Authorization (EUA) for Cue Health Inc.’s Cue COVID-19 Coronavirus Test.

This test is authorized for use at the Point of Care, that is, in patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Point-of-care testing means that results are delivered to patients in patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. This approach gives patients more immediate access to test results.
 

The FDA issued a warning letter to EUCYT Laboratories, LLC, for, among other things, marketing an unapproved exosome product for the treatment or prevention of COVID-19 Coronavirus. There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus.

Testing updates:

To date, the FDA has authorized 135 tests under EUAs, which include 114 molecular tests, 20 antibody tests, and 1 antigen test.

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)

Consumer Inquiries: 888.INFO.FDA

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.