FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests

COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below is a link to the most recent message about new FDA guidance for evaluating the impact of viral mutations on COVID-19 tests.

FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests

The U.S. Food and Drug Administration (FDA) recently issued new guidance for test developers. “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests” provides information on evaluating the potential impact of viral genetic mutations, which may be the basis of viral variants, on COVID-19 tests.