METADATA
last updated: 2026-03-02 RT
file_name: _context-commentary_regulatory-fl-fda-correspondence.md
category: regulatory
subcategory: fl-fda-correspondence
words: 1021
tokens: 1525


CONTENT

## Context
This subcategory contains FloodLAMP's direct correspondence with the FDA regarding its SARS-CoV-2 diagnostic test EUA submissions, spanning from October 2020 through October 2021. The files include pre-EUA requests, emails to FDA leadership, FDA deficiency letters, meeting notes, FloodLAMP's written responses, and the deprioritization/closure letters that ended FloodLAMP's EUA pursuit. For the submission documents themselves and technical background on the EUA process, see `regulatory/fl-fda-submissions/_context-commentary_regulatory-fl-fda-submissions.md`.

During the COVID-19 pandemic, the FDA's Center for Devices and Radiological Health (CDRH) managed EUA requests for diagnostic tests through a process that evolved substantially as submission volume grew. Communication between the FDA and test developers typically occurred through a combination of formal letters (deficiency notices, final decisions), email exchanges with assigned reviewers, optional pre-EUA feedback, and periodic virtual town halls open to the broader developer community. The FDA also offered short interactive review meetings — typically 30 minutes — to discuss specific submission issues.

For developers seeking EUAs, the process began with either a pre-EUA submission (to get preliminary feedback before a full filing) or a direct EUA submission. The FDA would then triage the submission based on prioritization factors — primarily whether the test would increase testing accessibility (point-of-care, at-home) or significantly expand testing capacity (high-throughput, high-volume manufacturing). Beginning in fall 2020, the FDA formalized a deprioritization system that included two mechanisms: "Decline to Review" for low-priority submissions and "Decline to Issue" for submissions with unresolved critical deficiencies. By September 30, 2021, the FDA had declined to review 558 EUA requests for COVID-19 tests. For more on deprioritization, see the companion research report `regulatory/fl-fda-correspondence/_AI_FDA Deprioritization of COVID-19 Diagnostic EUAs.md`.

FloodLAMP's correspondence documents the full arc of engagement with the FDA: early encouragement from OIVD Director Tim Stenzel on the open-source protocol approach (December 2020), initial EUA submissions and immediate deprioritization (March–April 2021), a pre-EUA that the FDA closed without reviewing the validation data (May–June 2021), a direct appeal to FDA leadership with real-world surveillance data (October 4, 2021), a 6-deficiency letter followed by a 30-minute Zoom meeting and written response (October 13–20, 2021), and final closure one day after FloodLAMP's response (October 21, 2021). The correspondence with the FDA on FloodLAMP's open-source EUA submissions is closely connected to two other regulatory subcategories: the FDA town halls (`regulatory/fda-townhalls`) where FloodLAMP engaged FDA leadership publicly, and the open EUAs concept (`regulatory/open-euas`) that was central to FloodLAMP's regulatory strategy.


## Commentary
FloodLAMP's experience with the FDA during the COVID-19 pandemic was defined by a persistent inability to obtain meaningful regulatory engagement on submissions that, by the FDA's own stated criteria, should have warranted review. The company developed a validated, instrument-free, colorimetric RT-LAMP test at a cost of $1–2 per reaction, designed as an open-source protocol modeled on the SalivaDirect EUA. The test was adopted by EMS agencies and municipal fire departments for routine surveillance screening. Despite multiple submissions, real-world deployment data, and direct appeals to FDA leadership, FloodLAMP received blanket deprioritization along with hundreds of other test developers. Had a meaningful review, let alone an EUA, been obtained in the spring of 2021, the trajectory of the company would have been fundamentally different.

For a detailed factual reconstruction and analysis of the critical October 2021 correspondence sequence that ended FloodLAMP's EUA pursuit, see `regulatory/fl-fda-correspondence/_AI_FloodLAMP FDA October 2021 Correspondence Analysis.md`. That document covers the complete timeline from October 2020 through October 2021, the FDA's stated justifications, and multiple interpretive explanations of the FDA's rationale. For related commentary on the FDA town halls and the open EUA concept, see `regulatory/fda-townhalls/_context-commentary_regulatory-fda-townhalls.md` and `regulatory/open-euas/_context-commentary_regulatory-open-euas.md`.

The first direct interaction with the FDA set the tone for what followed. In a November 2020 phone call for the pre-EUA, the assigned reviewer had not heard of SalivaDirect, DetectaChem, or even LAMP as a technology. The reviewer strongly recommended against pursuing anything involving asymptomatic testing or pooling, and instead recommended the narrowest possible indication: a single symptomatic person suspected of COVID-19. This was the starting position from which FloodLAMP had to make its case for the open-source screening model.

The FDA's rationale for deprioritization consistently came back to being short-staffed and resource-constrained. These were real constraints. But the response to those constraints — blanket deprioritization — failed a basic policy test. At the point FloodLAMP was deprioritized, the country was more than a year into the pandemic. The question the FDA should have been asking was: "Will this decision result in less testing?" When the answer was yes, creative solutions were warranted. The FDA could have established streamlined review tracks for open-protocol tests, created batch review processes for submissions using validated primer sets, facilitated reference panels for small developers, or simply provided actionable feedback rather than closing files without reviewing the data. None of these were pursued. The ITAP (Independent Test Assessment Program) eventually emerged as a partial alternative pathway, but it had limited access and transparency.

The October 4, 2021 letter to OIVD Director Tim Stenzel stands as one of the best summaries of FloodLAMP's case for its test and its work. In that letter, FloodLAMP presented real-world surveillance data from five sites across three states, approximately 2,300 people screened in 800 pools with three unknown positives detected and no known false negatives, alongside manufacturing readiness (2 million tests on hand, 3 million more at LGC Biosearch), $1–2 per test pricing, and active commercial sites with EMS and fire departments. Stenzel never responded. The review team sent a 6-deficiency letter nine days later, offered a 30-minute Zoom call the following day, received a substantive written response on October 20, and issued a final closure on October 21. The speed of that closure, one day after FloodLAMP's response that proposed a narrowed intended use and addressed multiple deficiencies, suggests the outcome was predetermined and the interactive review seemed to be procedural rather than genuinely deliberative.

Five weeks after the FDA closed FloodLAMP's submission, the Omicron variant was reported. By January 2022, the United States experienced the worst testing shortage of the entire pandemic. The principle behind the deprioritization decision — that the country did not need more tests — was catastrophically wrong, and it was applied systematically to FloodLAMP and hundreds of other test developers.