FloodLAMP FDA Townhall Engagement on Open Source FDA IVD EUAs and Generic Molecular Tests The “Dialogue on Open Source Testing and FDA IVD Authorization of Generic Molecular Tests” summarizes a December 9, 2020 FDA town hall exchange about using Rights of Reference and “method” EUAs (modeled on SalivaDirect) to enable interoperable, non-proprietary molecular test protocols across laboratories. It outlines how open IVD EUAs could reduce duplicative validation, strengthen supply-chain resilience, and scale testing via a structured lab designation process, positioning FloodLAMP’s strategy to expand this open-access paradigm beyond SalivaDirect. primary file regulatory fl-fda-correspondence 2020-12-09_FloodLAMP FDA Townhall Engagement on Open Source FDA IVD EUAs and Generic Molecular Tests.md regulatory/fl-fda-correspondence/2020-12-09_FloodLAMP FDA Townhall Engagement on Open Source FDA IVD EUAs and Generic Molecular Tests.md 2020_12_09 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 1462 2047 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