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FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants
October 4, 2021The US Food and Drug Administration on Thursday released additional conditions of authorization for certain SARS-CoV-2 tests that have received Emergency Use Authorizations, requiring test makers to update authorized labeling and evaluate the impact of variants on test performance.
The agency also issued recommendations to clinical laboratories and healthcare providers using the tests that the FDA said could be impacted by SARS-CoV-2 mutations.
In a letter establishing additional Conditions of Authorization on certain molecular, antigen, and serology tests for SARS-CoV-2, the agency is requiring developers to update authorized labeling within three months, submit the updates to the FDA as a supplement to the EUA, and evaluate the impact of viral mutations on test performance.