FDA Letter - Serology IVD Umbrella Revocation The FDA Serology IVD Umbrella Revocation letter announces the July 21, 2020 revocation of the April 28, 2020 umbrella EUA for certain SARS-CoV-2 antibody tests evaluated through NIH/NCI or other designated government validation. It explains that FDA shifted to issuing individual EUAs to allow test-specific indications, conditions of authorization, and more flexible amendments, even though no tests had been added to the umbrella EUA’s authorized list. This change tightened oversight and enabled more tailored regulatory control over serology test performance and labeling. primary file regulatory fda-policy 2020-07-21_FDA Letter - Serology IVD Umbrella Revocation.md regulatory/fda-policy/2020-07-21_FDA Letter - Serology IVD Umbrella Revocation.md 2020_07_21 pdf docx Public Domain 483 704 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