FDA Template - Home Specimen Collection Molecular Diagnostic Template The FDA Home Specimen Collection Molecular Diagnostic Template provides detailed recommendations for data, validation, and labeling needed to support pre-EUA/EUA submissions for prescription home collection kits used with authorized SARS-CoV-2 molecular assays. It specifies requirements for device description, manufacturing, shipping stability, usability, and clinical validation to ensure samples collected at home remain suitable for accurate laboratory testing. The template enables manufacturers and laboratories to standardize submissions and safely expand access to home-based COVID-19 specimen collection during the public health emergency. primary file regulatory fda-policy 2020-05-29_FDA Template - Home Specimen Collection Molecular Diagnostic Template.md regulatory/fda-policy/2020-05-29_FDA Template - Home Specimen Collection Molecular Diagnostic Template.md 2020_05_29 gdoc docx Public Domain 4869 6903 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