FDA COVID-19 Update

Monday, August 3, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • This week, the FDA issued an Emergency Use Authorization (EUA) for Cue Health Inc.’s Cue COVID-19 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. There are currently no FDA-approved products to prevent or treat COVID-19.
  • 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:

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