FDA Website - Revision Concerning Viral Mutations The Revision Concerning Viral Mutations summarizes FDA’s September 23, 2021 update to certain molecular, antigen, and serology COVID-19 test EUAs adding new Conditions of Authorization to address emerging SARS-CoV-2 variants. It requires EUA holders to monitor viral mutations for potential performance impacts, communicate identified risks to FDA and end users, and update and submit revised labeling within three months. The change was intended to reduce false negatives linked to decreased sensitivity or non-reactivity from new mutations, with specific exclusions for some EUA categories. primary file regulatory fda-policy 2021-09-23_FDA Website - Revision Concerning Viral Mutations.md regulatory/fda-policy/2021-09-23_FDA Website - Revision Concerning Viral Mutations.md 2021_09_23 date converted 2024-03-27 website Public Domain 284 435 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