Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests Guidance for Test Developers and Food and Drug Administration Staff
Written by U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (CDHR) Office of Product Evaluation and Quality (OPEQ)
FDA is issuing this guidance to provide a policy and recommendations on evaluating the potential impact of emerging and future viral mutations of SARS-CoV-2 on COVID-19 tests for the duration of the COVID-19 public health emergency. This guidance describes a policy for test developers to consider the impact of emerging and future variants on their COVID-19 tests during development and post-authorization. Throughout this guidance, references to COVID-19 tests are referring to molecular and antigen tests that detect the SARS-CoV-2 virus and serology tests that detect antibodies to the SARS-CoV-2 virus.