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The Regulatory category covers the policy and regulatory environment around COVID-19 testing, including FloodLAMP's own FDA submissions and correspondence, the surveillance framework it operated under, and related commentary on open-access diagnostics and pandemic preparedness.
Download the combined markdown of all converted archive files in this categoryA reference set of EUA documents FloodLAMP studied during development, including comparable authorized tests and instructive examples of the FDA's authorization model.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryThe evolving FDA policy framework for COVID-19 testing, including guidance versions, templates, screening policy, pooling policy, and transition-era materials.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryFloodLAMP's own EUA submissions and Instructions for Use documents, including for the primary test utilized in FloodLAMP's real-world pilot programs ("QuickColor" extraction-free colorimetric LAMP test) and for a companion "EasyPCR" test run from the same inactivated sample and utilizing the SalivaDirect primers and probes. Also addressed is the broader open-source protocol regulatory strategy.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryThe direct written record of FloodLAMP's interactions with the FDA, including pre-EUA contacts, review communications, deficiency letters, and closure of the submission effort.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryProtocol and consent materials for the clinical-study path FloodLAMP prepared but never carried through, plus commentary on the cost and friction of the process.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryBackground on the LDT regulatory pathway and how it intersected with FDA policy, commercial IVDs, and the open-EUA ideas that mattered to FloodLAMP.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryMaterials on the open-EUA concept that sat at the center of FloodLAMP's regulatory strategy: open protocols, open supply chains, and shared access to authorization.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryBroader third-party reports, proposals, and retrospective analyses that help place FloodLAMP's regulatory experience in a larger pandemic-policy context.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategoryThe regulatory gray-zone framework FloodLAMP ultimately operated under in practice, including how non-diagnostic surveillance was explained, justified, and limited.
Open the fuller context and commentary Download the combined markdown of all converted archive files in this subcategory