FDA Template - Molecular Diagnostic Template for Commercial Manufacturers The FDA Molecular Diagnostic Template for Commercial Manufacturers is a detailed regulatory framework outlining recommended data, validation studies, and documentation for pre-EUA and EUA submissions of SARS-CoV-2 molecular diagnostic tests. It standardizes how manufacturers present analytical, clinical, manufacturing, and pooling performance information to FDA during the COVID-19 public health emergency. primary file regulatory fda-policy 2020-07-28_FDA Template - Molecular Diagnostic Template for Commercial Manufacturers.md regulatory/fda-policy/2020-07-28_FDA Template - Molecular Diagnostic Template for Commercial Manufacturers.md 2020_07_28 docx docx Public Domain 15074 20960 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