FDA Guidance - COVID IVD Test Developers v2 The FDA Guidance for COVID IVD Test Developers v2 expands the February 29, 2020 policy by covering not only CLIA high-complexity laboratory-developed molecular tests but also state-authorized testing pathways, commercial manufacturer test distribution prior to EUA, and serology testing policies during the public health emergency. It provides validation study recommendations by test type (molecular, antigen, serology) and sets expectations for notification, transparency in reporting, and EUA submission timelines while allowing limited use during review. The guidance helped scale U.S. testing capacity by defining flexible, risk-managed routes for labs and manufacturers to deploy validated tests quickly. primary file regulatory fda-policy 2020-03-16_FDA Guidance - COVID IVD Test Developers v2.md regulatory/fda-policy/2020-03-16_FDA Guidance - COVID IVD Test Developers v2.md 2020_03_16 pdf docx Public Domain 4566 5900 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