FDA Guidance - COVID IVD Test Developers v4 The FDA Guidance for COVID IVD Test Developers v4 updates the May 4, 2020 policy by emphasizing the expanded availability of downloadable EUA templates for different COVID-19 test types and clarifying expectations for labs, states, and commercial manufacturers operating under enforcement discretion during the public health emergency. It maintains the core “validate + notify + submit EUA within a defined window” framework (including listing/removal on FDA’s notification pages) while continuing tighter controls and labeling expectations for serology tests and broader validation guidance for molecular, antigen, and serological assays. The guidance helps developers navigate a more standardized EUA process by pairing policy flexibilities with clearer submission tools and oversight triggers. primary file regulatory fda-policy 2020-05-11_FDA Guidance - COVID IVD Test Developers v4.md regulatory/fda-policy/2020-05-11_FDA Guidance - COVID IVD Test Developers v4.md 2020_05_11 pdf docx Public Domain 7302 9407 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