Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests (from CDC, updated May 22, 2020)
- On May 21, 2020, the U.S. Food and Drug Administration (FDA) announced that it has removed a number of antibody tests from the “notification list” of tests offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
- The list of the removed antibody tests is posted on FDA’s frequently asked questions website.
- Antibody tests on this removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer, and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA.
- FDA expects that the tests on the removal list will not be marketed or distributed.
Read the entire document here. FDA Transparency for Covid-19 Antibody Tests
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