FDA Website - EUA for Molecular Diagnostic Tests The FDA umbrella EUA for molecular laboratory-developed tests (LDTs) for SARS-CoV-2 outlines eligibility criteria, including CLIA high-complexity certification and use limited to the single developing laboratory, with authorized tests listed in Appendix A. It also notes the November 15, 2021 reissuance that limited authorization to tests already in Appendix A and provides links to the authorization letter and provider/patient fact sheets. primary file regulatory fda-policy 2020-03-31_FDA Website - EUA for Molecular Diagnostic Tests.md regulatory/fda-policy/2020-03-31_FDA Website - EUA for Molecular Diagnostic Tests.md 2020_03_31 date converted 2024-03-27 website Public Domain 170 285 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