Email to FDA CDRH - Request for Guidance The Email to FDA CDRH - Request for Guidance (Oct 22, 2020) outlines FloodLAMP’s pre-EUA request to the FDA for feedback on validating a pooled SARS-CoV-2 RT-LAMP screening program, including proposed pooling levels, turnaround targets, and two assay configurations (fluorimetric and colorimetric) with preliminary LoD data. It’s useful as an early regulatory-facing snapshot of FloodLAMP’s technical approach, intended use in asymptomatic group screening, and the specific guidance and template updates they were seeking to shape an EUA-ready validation plan. primary file regulatory fl-fda-correspondence 2020-10-22_Email to FDA CDRH - Request for Guidance.md regulatory/fl-fda-correspondence/2020-10-22_Email to FDA CDRH - Request for Guidance.md 2020_10_22 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 537 736 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