FDA Template - For Developers of Molecular Diagnostic Tests The FDA “Template for Developers of Molecular Diagnostic Tests” is a detailed pre-EUA/EUA submission template outlining recommended validation, clinical study design, and labeling content for SARS-CoV-2 molecular diagnostics. It covers core analytical studies (LoD, inclusivity/variant monitoring, cross-reactivity, interference, stability), clinical performance expectations for symptomatic and asymptomatic screening populations, and requirements for pooled testing, including validation approaches and ongoing pooling monitoring/re-assessment. It is used by developers to structure submissions and align evidence packages with FDA review criteria, including manufacturing, software, reporting, and post-authorization obligations. primary file regulatory fda-policy 2021-10-06_FDA Template - For Developers of Molecular Diagnostic Tests.md regulatory/fda-policy/2021-10-06_FDA Template - For Developers of Molecular Diagnostic Tests.md 2021_10_06 docx docx Public Domain 20940 31076 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