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Email to FDA Dir Tim Stenzel - FloodLAMP Pre-EUA The Email to FDA Dir Tim Stenzel - FloodLAMP Pre-EUA (Nov 10, 2020) is an outreach note requesting a meeting to discuss FloodLAMP’s newly submitted pre-EUA for an ultra-low-cost, LAMP-based SARS-CoV-2 test and how an “open source” EUA model could be expanded beyond SalivaDirect. It highlights key regulatory topics FloodLAMP wanted to align on—especially asymptomatic screening, pooling, and on-site/at-home collection—and proposes forming a consortium of mission-driven developers to produce validated, open-access molecular tests. primary file regulatory fl-fda-correspondence 2020-11-10_Email to FDA Dir Tim Stenzel - FloodLAMP Pre-EUA.md regulatory/fl-fda-correspondence/2020-11-10_Email to FDA Dir Tim Stenzel - FloodLAMP Pre-EUA.md 2020_11_10 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 281 382 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
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