FDA Fact Sheet - Sample Updated Fact Sheet for Patients The FDA “Sample Updated Fact Sheet for Patients” is a standardized, fill-in template that EUA test sponsors provide to individuals whose samples were tested for COVID-19 with an authorized device. It explains what the test is, why someone may be tested (including serial and pooled testing), and what positive or negative results mean, including the risks of false positives/negatives and recommended follow-up actions. It supports clear patient-facing communication of EUA status, benefits/limitations, and where to find additional public health guidance. primary file regulatory fda-policy 2021-04-20_FDA Fact Sheet - Sample Updated Fact Sheet for Patients.md regulatory/fda-policy/2021-04-20_FDA Fact Sheet - Sample Updated Fact Sheet for Patients.md 2021_04_20 pdf Public Domain 1273 1652 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