FDA Template - For Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Home Use The FDA “Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Home Use” outlines recommended validation and labeling for SARS-CoV-2 tests intended for self-testing at home and other non-laboratory settings, including OTC and prescription pathways. It specifies expected analytical and clinical performance evidence plus home-use specific studies such as usability, user comprehension, flex/robustness testing, and software/mobile-app validation and reporting workflows. It is used by test developers to structure pre-EUA/EUA submissions and create clear, low-reading-level instructions, packaging, and mitigations appropriate for lay users. primary file regulatory fda-policy 2021-11-09_FDA Template - For Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Home Use.md regulatory/fda-policy/2021-11-09_FDA Template - For Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Home Use.md 2021_11_09 docx docx Public Domain 7412 10768 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