FloodLAMP FDA Correspondence and 10-14 Meeting Notes The email thread documents FDA’s October 2021 interactive review of FloodLAMP’s EUA210582 QuickColor COVID-19 Test, including an FDA request for additional information, a follow-up offer to meet by Zoom, and FloodLAMP’s written response arguing for an amended serial-screening intended use. It captures key feedback from FDA reviewers about open-protocol EUA/designation concerns, the need for acceptable clinical evidence for serial screening, and constraints around reference panels, followed by FDA’s deprioritization/closure letter and FloodLAMP’s appeal for reconsideration. The final exchange confirms FDA understood the intended-use amendment but deemed FloodLAMP’s clinical study inadequate for screening with serial testing, directing FloodLAMP to the updated molecular EUA template or a pre-EUA supplement for study-design feedback. primary file regulatory fl-fda-correspondence 2021-10-13_FloodLAMP FDA Correspondence and 10-14 Meeting Notes.md regulatory/fl-fda-correspondence/2021-10-13_FloodLAMP FDA Correspondence and 10-14 Meeting Notes.md 2021_10_13 attachments changed from gdoc version gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 2051 4121 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