FDA says developers must disclose impact of SARS-CoV-2 variants on test performance

Sept. 24, 2021

The U.S. Food and Drug Administration (FDA) released rules requiring diagnostic test developers to evaluate the impact of SARS-CoV-2 variants on the performance of their COVID-19 tests on an ongoing basis and include that information in each test’s labeling.

In a letter to test developers dated September 23, the FDA said the additional requirements for emergency use authorization (EUA) apply to molecular, antigen and serology assays.

For multi-analyte tests, the FDA said test developers must evaluate the impact of SARS-CoV-2 viral mutations and all other target analytes.

All data from the performance evaluations must be submitted to the FDA, and developers will be required to submit additional data that the FDA requests in response to its concerns about test performance with 48 hours.

In addition, the agency says, “If requested by FDA, you must update your labeling within 7 calendar days to include any additional labeling risk mitigations identified by FDA regarding the impact of viral mutations on test performance,” The FDA said.

The new conditions apply to all tests that currently have EUAs from the FDA as well as new applications for EUA authorization. The revision to the EUA rules does not apply to IL-6 assays, standalone specimen collection devices or home collection kits.

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