FDA Letter - Laboratories Who Have Developed a Molecular-Based Test The FDA “Laboratories Who Have Developed a Molecular-Based Test” letter (Nov 15, 2021) reissues and narrows an EUA for certain molecular laboratory-developed tests listed in Appendix A, authorizing them only for qualitative SARS-CoV-2 detection in respiratory specimens from individuals suspected of COVID-19 by a healthcare provider. It explains that no additional tests will be added under this EUA and updates conditions and fact sheets to reflect the current phase of the pandemic and FDA’s shift toward separate serial screening/pooling pathways. It also sets enforceable conditions for authorized single-lab use (CLIA high complexity), reporting, labeling, adverse event tracking, and ongoing evaluation of viral mutation impacts. primary file regulatory fda-policy 2021-11-15_FDA Letter - Laboratories Who Have Developed a Molecular-Based Test.md regulatory/fda-policy/2021-11-15_FDA Letter - Laboratories Who Have Developed a Molecular-Based Test.md 2021_11_15 pdf Public Domain 2599 3586 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