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

 

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

The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test.

Coronavirus.

Coronavirus.

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.

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.


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