FDA Guidance - COVID IVD Test Developers v3 The FDA Guidance for COVID IVD Test Developers v3 revises the March 16, 2020 policy to further scale pandemic testing while tightening oversight, especially for commercial serology tests, and adding streamlined EUA templates and pathways (including NIH/NCI-evaluated serology under an umbrella EUA). It keeps the core CLIA lab and commercial manufacturer “validate + notify + submit EUA within a set window” approach but adds clearer enforcement levers like FDA website listing/removal if submissions aren’t timely and more explicit rules for modifications and bridging studies. The guidance provides updated validation recommendations by test type and reflects the shift from early flexibility toward stronger performance and labeling controls as more data and market experience accumulated. primary file regulatory fda-policy 2020-05-04_FDA Guidance - COVID IVD Test Developers v3.md regulatory/fda-policy/2020-05-04_FDA Guidance - COVID IVD Test Developers v3.md 2020_05_04 pdf docx Public Domain 14273 18972 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