FDA Fact Sheet - Fact Sheet for Patients Template The FDA “Fact Sheet for Patients Template” (v1.0, Nov 15, 2021) is a fill-in patient-facing document for EUA-authorized COVID-19 testing that explains what the test is, why someone may be tested (including serial testing), and how to interpret positive and negative results. It includes optional standardized language for pooled testing, follow-up and emergency-care guidance, and required EUA status and alternatives statements tied to the umbrella EUA for serial testing. It helps labs and test sponsors provide consistent, plain-language risk/benefit and next-step instructions to individuals receiving results. primary file regulatory fda-policy 2021-11-15_FDA Fact Sheet - Fact Sheet for Patients Template.md regulatory/fda-policy/2021-11-15_FDA Fact Sheet - Fact Sheet for Patients Template.md 2021_11_15 docx docx Public Domain 1327 1791 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