FDA Fact Sheet - Test Summary Template The FDA “Test Summary Template” is an EUA-ready summary document for a laboratory-developed SARS-CoV-2 molecular test that standardizes how intended use, test principles, instruments/reagents, controls, result interpretation, and performance data are presented. It includes optional sections for pooling, home collection, and asymptomatic screening, plus required language on confirmatory testing considerations and variant-related performance limitations. It helps CLIA high-complexity laboratories package key validation and labeling elements in a consistent format aligned with the umbrella EUA for serial testing. primary file regulatory fda-policy 2021-11-15_FDA Fact Sheet - Test Summary Template.md regulatory/fda-policy/2021-11-15_FDA Fact Sheet - Test Summary Template.md 2021_11_15 docx docx Public Domain 2611 3812 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url