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# FDA Revises Authorizations of Some Covid Tests
- URL: https://www.fdaweb.com/fda-revises-authorizations-of-some-covid-tests/
- Published: 2021-09-23T12:00:00.000Z
- Updated: 2026-09-14T17:15:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150204

FDA says it has revised the authorizations of certain molecular, antigen, and serological tests for Covid-19 to help ensure that the tests’ performance is not affected by emerging SARS-CoV-2 viral mutations. An agency [announcement](https://content.govdelivery.com/accounts/USFDA/bulletins/2f430f2?ref=fdaweb.com) says the revisions require additional conditions of authorization concerning viral mutations.

FDA says the viral mutation revision **(1)** applies to most authorized SARS-CoV-2 molecular, antigen, and serology tests; **(2)** requires developers of tests that are written within the scope of the revision to monitor emerging viral mutations and their potential impact on the performance of authorized SARS-CoV-2 tests; and **(3)** also requires such test developers to update the test labeling and communicate potential risks with the test’s intended users.

Additional information from FDA is [here](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests?utm%5Fmedium=email&utm%5Fsource=govdelivery).