FDA Guidance - COVID IVD Test Developers v1 The FDA Guidance for COVID-19 IVD Test Developers v1 establishes an accelerated policy allowing CLIA-certified high-complexity laboratories to develop, validate, and use SARS-CoV-2 molecular diagnostic tests prior to Emergency Use Authorization during the early public health emergency. It outlines minimum expectations for validation, FDA notification, result reporting, and EUA submission while permitting temporary clinical use to rapidly expand testing capacity. This guidance shaped early laboratory testing practices by balancing speed with basic analytical and clinical safeguards. primary file regulatory fda-policy 2020-02-29_FDA Guidance - COVID IVD Test Developers v1.md regulatory/fda-policy/2020-02-29_FDA Guidance - COVID IVD Test Developers v1.md 2020_02_29 pdf docx Public Domain 1961 2610 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