FDA Guidance - COVID IVD Test Developers v6 The FDA “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)” (v6, Sept 27, 2022) updates FDA’s review priorities and enforcement policies for COVID-19 diagnostic and serology IVDs, superseding the November 15, 2021 version. It narrows EUA review to a smaller set of tests and supplemental requests from experienced developers that address unmet needs (e.g., variants or innovative technologies), while encouraging most developers to pursue traditional premarket pathways. It also clarifies ongoing policies for tests previously offered during FDA review, state-authorized single-lab testing, permitted modifications to authorized molecular tests, and baseline expectations for validation and reporting. primary file regulatory fda-policy 2022-09-27_FDA Guidance - COVID IVD Test Developers v6.md regulatory/fda-policy/2022-09-27_FDA Guidance - COVID IVD Test Developers v6.md 2022_09_27 pdf Public Domain 5857 8418 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