FDA Website - Umbrella EUA The Umbrella EUA describes FDA’s November 15, 2021 authorization for certain laboratory-developed RT-PCR SARS-CoV-2 tests using anterior nasal specimens for serial testing programs, including optional pooled testing and screening of asymptomatic individuals at least weekly. It specifies eligibility criteria, pooling parameters that vary by appendix (pool sizes up to 10, media vs. swab pooling, and possible home collection), and limits use to the single CLIA-certified high-complexity laboratory that developed the test. It also explains the notification/self-certification process for being added to Exhibit 1 and notes that listing does not necessarily mean FDA reviewed the underlying validation data. primary file regulatory fda-policy 2021-11-15_FDA Website - Umbrella EUA.md regulatory/fda-policy/2021-11-15_FDA Website - Umbrella EUA.md 2021_11_15 date converted 2024-03-27 website Public Domain 352 507 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