FDA: Certain COVID-19 tests must evaluate how variants affect performance

Sep 23, 2021 - 03:01 PM
FDA-guidance

The Food and Drug Administration today required certain COVID-19 test developers to evaluate how SARS-CoV-2 mutations impact their test’s performance and update the labeling for the product accordingly. The new conditions for emergency use authorization pertain to certain authorized molecular, antigen and serological tests.
 

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