FloodLAMP Open EUAs - Open-Source Protocol and Open-Access Authorization for Diagnostic Tests
Research report on "open EUAs" -- the combination of open-source diagnostic protocols with open-access FDA authorization -- centered on SalivaDirect as the canonical example. Covers the regulatory mechanics of the steward/designation model, evidence of uptake in press and academia, pre-pandemic antecedents, reasons the model did not proliferate during COVID-19, a detailed analysis of the CDC test as a government "open" diagnostic with structural limitations, and a practical framework for future open-access diagnostics. Includes a comparative openness table across six COVID-19 EUA test categories.
ai
file
regulatory
open-euas
_AI_open-euas-open-access-diagnostics-report.md
regulatory/open-euas/_AI_open-euas-open-access-diagnostics-report.md
2026_03_02
Initially created by ChatGPT Pro 5.2 Extended, edited by Opus 4.6 and RT during archive preparation. **PARTIALLY HUMAN EDITED/VERIFIED - MAY CONTAIN ERRORS** Research report analyzing the "open EUA" concept (open-source protocol combined with open-access authorization) centered on SalivaDirect as the canonical example, with analysis of the CDC test, pre-pandemic antecedents, regulatory barriers to proliferation, and implications for future open-access diagnostics. Key sources include FDA authorization documents, SalivaDirect retrospective literature, policy analyses, and FloodLAMP archive materials.
open-eua, open-source-diagnostics, salivadirect, fda-eua, cdc-test, open-access, ldt-oversight
md
CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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