FDA Guidance - COVID IVD Test Developers v7 The FDA “Policy for Coronavirus Disease-2019 Tests (Revised)” (7th edition, January 12, 2023) outlines FDA’s EUA review priorities and enforcement policies for COVID-19 diagnostic and serology tests during the section 564 emergency declaration. It explains when tests may be distributed or offered during FDA review, what disclosures and performance information should accompany non-authorized tests, and how high-complexity CLIA labs can make certain modifications to EUA-authorized molecular tests without a new EUA if validated and limited to that lab. primary file regulatory fda-policy 2023-01-12_FDA Guidance - COVID IVD Test Developers v7.md regulatory/fda-policy/2023-01-12_FDA Guidance - COVID IVD Test Developers v7.md 2023_01_12 pdf Public Domain 5457 8029 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