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- Updated Serology EUA COVID-19 Templates Available
On March 17, the Food and Drug Administration (FDA) released two templates with recommendations on what to include in Emergency Use Authorization (EUA) requests or pre-EUA submissions for COVID-19 serology tests, including one for serology tests that detect neutralizing antibodies. Additionally, the FDA updated serology template for test developers clarified recommendations regarding monitoring for and assessing the impact of new SARS-CoV-2 mutations and variants.
These FDA templates provide current recommendations concerning what data and information should be submitted to the FDA to support an EUA request or pre-EUA submission for SARS-CoV-2 antibody tests. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
Download the new templates.