Cover Letter to FDA - FloodLAMP Open Source EUA Submissions The "2021-03-22_Cover Letter to FDA - FloodLAMP Open Source EUA Submissions" document is a cover letter to the FDA that accompanied FloodLAMP Open Source EUA Submissions. It summarizes FloodLAMP’s follow-up to a pre-EUA with two full EUA submissions: the QuickColor colorimetric LAMP test and the EasyPCR duplex PCR test, both using a shelf-stable chemical plus heat inactivation workflow. It positions the assays as open-source, supply-chain-resilient protocols (modeled on SalivaDirect) and highlights primer sourcing, clinical performance claims, intended screening use cases, and supporting plans for IRB studies and a companion mobile app. primary file regulatory fl-fda-correspondence 2021-03-22_Cover Letter to FDA - FloodLAMP Open Source EUA Submissions.md regulatory/fl-fda-correspondence/2021-03-22_Cover Letter to FDA - FloodLAMP Open Source EUA Submissions.md 2021_03_22 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 518 716 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