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.
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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
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CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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