FDA Guidance - COVID IVD Test Developers v2 The "2020-03-16_FDA Guidance - COVID IVD Test Developers v2" document 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 stated goal was to 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