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

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance: Policy for Evaluating the Impact of Viral Mutations on COVID-19 Tests.

Read the Guidance

This immediately in effect guidance:

• Describes recommendations for test developers to consider the impact of emerging and future viral mutations of SARS-CoV-2 on their COVID-19 tests prior to and post-authorization. 
• Applies to COVID-19 test developers of molecular and antigen diagnostic tests, and serology tests that have been issued an Emergency Use Authorization (EUA) from the FDA, COVID-19 test developers that are offering their tests as outlined in the FDA’s testing guidance, and COVID-19 test developers pursuing an EUA from the FDA. 
• Provides recommendations on information to include in EUA requests or supplemental EUA requests.
• Describes the FDA’s activities to better understand the public health impact of new virus variants and the potential impact on authorized COVID-19 tests.

For more information, see the Press Release: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants.

Questions?

If you have questions about this guidance, email COVID19DX@fda.hhs.gov.