FDA Template - Antigen Template for Test Developers The FDA “Antigen Template for Test Developers” is an interactive EUA review template that specifies the data, validation studies, and labeling information recommended for SARS-CoV-2 antigen test submissions. It details analytical, clinical, stability, manufacturing, software, and point-of-care performance expectations to support intended use claims, including screening and asymptomatic testing. It is used by test developers to structure pre-EUA/EUA submissions and align study design with FDA review expectations during the COVID-19 public health emergency. primary file regulatory fda-policy 2020-10-26_FDA Template - Antigen Template for Test Developers.md regulatory/fda-policy/2020-10-26_FDA Template - Antigen Template for Test Developers.md 2020_10_26 docx docx Public Domain 8393 13046 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