On May 4, 2020, the US Food and Drug Administration (FDA) updated its enforcement policy on antibody tests for COVID-19. The revised policy requires developers of commercial antibody tests to submit a request for emergency use authorization (EUA) to FDA. Under the previous policy, commercial test developers could distribute their tests without FDA authorization. The change in policy reflects growing concerns over the reliability of antibody tests currently on the market. The policy shift also suggests that manufacturers of medical supplies subject to relaxed enforcement policies during COVID-19 should monitor policy developments to confirm the regulatory status of their products.
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