Cover Letter to FDA - FloodLAMP Open Source EUA Submissions
The Cover Letter to FDA for FloodLAMP Open Source EUA Submissions 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