U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup September 18, 2020 | site |



(September 18, 2020) - - Today, September 18, 2020, the U.S. Food and Drug Administration published the following information:

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
  • The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to:
    • Indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.”
    • Clarify that testing is authorized for laboratories certified under CLIA and meet the requirements to perform high, moderate, or waived complexity tests.
    • Clarify that testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities.
  • The reissuance also:
    • Revised the labeling to update specimen transport and storage recommendations and to include results of the FDA SARS-CoV-2 Reference Panel Testing.
    • Updated conditions of authorization to reflect consistency with more recent authorizations.
    • Revised the health care provider and patient fact sheets to reflect the intended use updates and language more consistent with recent authorizations.
  • Testing updates:
As of today, 248 tests are authorized by FDA under EUAs; these include 198 molecular tests, 46 antibody tests, and 4 antigen tests.