FDA Template - For Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use The FDA Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use outlines recommended data, validation studies, and submission structure for pre-EUA and EUA requests covering home and other non-laboratory testing settings. It emphasizes analytical performance, usability, flex studies, clinical evaluation in symptomatic and asymptomatic users, and result reporting to public health authorities. The template guides manufacturers in designing and documenting tests intended for lay users while addressing the higher risk of user error outside traditional laboratories. primary file regulatory fda-policy 2020-07-29_FDA Template - For Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use.md regulatory/fda-policy/2020-07-29_FDA Template - For Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use.md 2020_07_29 docx docx Public Domain 6688 9546 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