FDA Update on COVID-19 Antibody Tests

May 22, 2020 | COVID-19

On May 21, 2020, the Food and Drug Administration (FDA) posted a list of antibody tests that are being removed from the list of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

On March 16, 2020, the FDA issued guidance to help accelerate the availability of COVID-19 tests developed by laboratories and commercial manufacturers for the duration of the COVID-19 public health emergency. The FDA subsequently announced a revised guidance recommending that commercial manufacturers of antibody tests submit an Emergency Use Authorization (EUA) request within 10 business days from the date they notified FDA of their test validation or the date of publication of the revised policy, whichever was later.

The FDA is providing a list of antibody tests from commercial manufacturers that have been removed from the antibody test notification list. The list includes tests for which an EUA request has not been submitted by a commercial manufacturer within a reasonable period of time, or tests where significant problems were identified that cannot be or have not been addressed in a timely manner. It is expected that this removal list will continue to be updated. As of May 21, 2020, there are 28 tests that have been removed from the antibody test notification list. The list is available here.

Food and Drug Administration (FDA). Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests. May 21, 2020. Available at: click here. Accessed May 21, 2020.

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