April 16, 2020

FDA updates actions taken in response to COVID-19

Editor's Note

Among the actions announced April 15 by the Food & Drug Administration (FDA) in response to the COVID-19 pandemic are:

  • Issuance of two new emergency use authorizations (EUAs) for serology tests, to detect for presence of coronavirus antibodies, to Ortho-Clinical Diagnostics, Inc, and Chembio Diagnostic systems, Inc.
  • Issuance of an EUA for the use of Stryker Instrument’s Sterizone VP4 Sterilizer N95 Respirator Decontamination Cycle for decontaminating N95 respirators.
  • Issuance of a “Guidance on digital health devices for treating psychiatric disorders” in an effort to expand the availability of these devices while reducing user and healthcare provider contact.

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