FDA Letter - EUA Letter of Authorization The FDA “EUA Letter of Authorization” (November 15, 2021) is the legally operative document that authorizes certain laboratory-developed RT-PCR SARS-CoV-2 tests under an Umbrella EUA for Serial Testing. It defines who may use the test (a single CLIA high-complexity laboratory), exactly what indications are authorized (individual and pooled anterior nasal specimens used at least weekly, including asymptomatic screening), and the validation pathways required for each indication (Appendices A–K). The letter also establishes binding Conditions of Authorization, including labeling requirements, post-authorization studies, mutation monitoring, pooling controls, reporting obligations, and limits on modifications. Only tests that meet the nine eligibility criteria and are properly added to Exhibit 1 are considered authorized. primary file regulatory fda-policy 2021-11-15_FDA Letter - EUA Letter of Authorization.md regulatory/fda-policy/2021-11-15_FDA Letter - EUA Letter of Authorization.md 2021_11_15 pdf Public Domain 17668 24421 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