FDA Takes New Action to Help Ensure Performance of COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 09/23/2021 10:57 AM EDT

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FDA - Center for Devices and Radiological Health

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FDA Takes New Action to Help Ensure the Performance of COVID-19 Tests

Today, the U.S. Food and Drug Administration (FDA) took additional steps to help ensure that the performance of authorized COVID-19 tests is not impacted by emerging SARS-CoV-2 viral mutations.

The FDA revised the authorizations of certain molecular, antigen, and serological tests for COVID-19 by requiring additional conditions of authorization concerning viral mutations.

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The Viral Mutation Revision:

  • Requires developers of tests that are within the scope of this revision to monitor emerging viral mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.
  • Also requires such test developers to update the test labeling and communicate potential risks with the test’s intended users consistent with the letter.

The FDA will continue to share updates as new information becomes available.

Questions?

If you have questions about the amendment, email COVID19Dx@fda.hhs.gov.