FDA Guidance - COVID IVD Test Developers v5 The FDA “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)” (v5, Nov 15, 2021) sets the overarching regulatory and enforcement framework for COVID-19 diagnostic and serology IVDs during the pandemic. It defines FDA’s EUA review priorities, expectations for validation, rules for offering tests during FDA review, state and laboratory policies, and how authorized tests may be modified. It guides developers and laboratories on which tests FDA will prioritize, how to maintain compliance, and when EUA authorization is expected before distribution. primary file regulatory fda-policy 2021-11-15_FDA Guidance - COVID IVD Test Developers v5.md regulatory/fda-policy/2021-11-15_FDA Guidance - COVID IVD Test Developers v5.md 2021_11_15 pdf Public Domain 7947 11054 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