FDA removes tests from list of antibody tests under review

May 22, 2020 - 02:44 PM
FDA product update

The Food and Drug Administration yesterday posted a list of COVID-19 antibody tests that will no longer be marketed because they have not been authorized for emergency use under its revised policy, or the manufacturer withdrew them from the list of tests under review for emergency use.

To help ensure COVID-19 antibody tests are trustworthy, the agency revised its guidance May 4 to recommend manufacturers request an emergency use authorization within 10 business days after they validate their test.

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