METADATA
last updated: 2026-03-02 RT
file_name: _context-commentary_regulatory-fl-fda-submissions.md
category: regulatory
subcategory: fl-fda-submissions
words: 1401
tokens: 2051


CONTENT

## Context
This subcategory contains FloodLAMP's FDA Emergency Use Authorization (EUA) submissions and associated Instructions for Use (IFU) documents for its SARS-CoV-2 diagnostic tests. There are 15 files spanning from November 2020 to October 2021, representing the full arc of FloodLAMP's regulatory submission effort. For background on the EUA framework itself and how it differs from standard 510(k) IVD approvals, see the FDA policy subcategory `regulatory/fda-policy`. For the correspondence with the FDA that accompanied these submissions, see `regulatory/fl-fda-correspondence`.

The subcategory documents four distinct test products and several ancillary submissions. The "QuickColor" test is the main FloodLAMP test, and one that was used for all of FloodLAMP's surveillance pilot programs. When the "FloodLAMP test" is used throughout the files in this archive, the QuickColor test is the one being referred to.

- **FloodLAMP Glass Milk LAMP Test** (Pre-EUA, November 2020): The earliest submission, a colorimetric RT-LAMP assay using silica ("glass milk") purification of nucleic acids from saliva and anterior nares swab specimens (from the Harvard Rabe-Cepko protocol). This was a pre-EUA — a preliminary package submitted to initiate FDA engagement and enter the review queue. It targeted asymptomatic screening with sample pooling at a baseline level of 10. The limit of detection (LoD) was 2 copies/uL (approximately 2,000 copies/mL).

- **FloodLAMP EasyPCR COVID-19 Test** (EUA Submission + IFU, v1.0 March 2021, v1.1 May 2021): An extraction-free, duplex RT-qPCR assay using the CDC N1 and human RNaseP primer-probe sets, with TCEP-based chemical inactivation and heat treatment. It required standard RT-PCR instruments (QuantStudio, Bio-Rad CFX96) but no nucleic acid extraction equipment. The LoD was 3,100 copies/mL. Clinical evaluation at Stanford showed 97.5% positive agreement and 100% negative agreement against a high-sensitivity comparator on 80 specimens.

- **FloodLAMP QuickColor COVID-19 Test** (EUA Submission + IFU, v1.0 March 2021, v1.1 May 2021, v1.2 draft October 2021): An extraction-free, colorimetric RT-LAMP assay with a visual pink-to-yellow readout requiring no specialized instrumentation. It used 18 LAMP primers targeting three SARS-CoV-2 genes (ORF1ab, N, E) and the same TCEP-based inactivation as the EasyPCR test. The LoD was 12,500 copies/mL. Clinical evaluation at Stanford showed 90% positive agreement and 100% negative agreement on 80 specimens. The v1.2 IFU introduced triplicate repeat procedures for inconclusive results.

- **FloodLAMP FLAMP (QuickFluor) COVID-19 Test** (EUA Submission + IFU draft, March 2021, NOT SUBMITTED): A fluorimetric RT-LAMP assay using real-time fluorescence readout on RT-PCR instruments. It used the same primers and inactivation as QuickColor but with fluorescent detection instead of colorimetric. The LoD was 50,000 copies/mL and clinical evaluation showed 80% positive agreement. This test was prepared but never submitted to the FDA.

- **Pooled Swab Collection and Screening Studies** (Pre-EUA submissions, May 2021): Three documents supporting FloodLAMP's pooling and asymptomatic screening strategy — a pre-EUA for a direct-to-consumer pooled swab collection kit (allowing 1–4 self-collected anterior nasal swabs in a single tube), collection kit instructions, and a proposed validation study design for pooling and serial asymptomatic screening aligned to FDA guidance.

Each submission follows the FDA's EUA template structure: purpose, measurand, applicant information, regulatory status, proposed intended use, device description and test principle, controls, interpretation of results, manufacturing and component sourcing, and performance evaluation (LoD, inclusivity, cross-reactivity, interfering substances, clinical evaluation). The IFU documents mirror much of this content in an operational format for laboratory use.

All of FloodLAMP's tests shared a common TCEP-based chemical inactivation step and were designed as "open source protocol" tests — meaning designated CLIA high-complexity laboratories could source all components directly from commercial vendors rather than purchasing proprietary kits. This open-source approach is central to FloodLAMP's strategy, as documented in the `regulatory/open-euas` subcategory. The EasyPCR and QuickColor tests were designed to work as an integrated pair: QuickColor for high-throughput colorimetric screening (45-minute turnaround, no instruments) and EasyPCR for rapid PCR-based confirmation (~1 hour 45 minutes). New England Biolabs supported both tests with their LAMP master mix and Luna RT-qPCR kit, and LGC Biosearch Technologies supplied production-scale LAMP primer sets.

The submissions evolved across versions. The v1.0 submissions (March 2021) proposed intended use for "individuals suspected of COVID-19 by their healthcare provider and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested at a weekly interval." The v1.1 submissions (May 2021) reframed the intended use around "routine screening programs" in settings like schools and workplaces. None of these submissions received FDA authorization.


## Commentary
The primary commentary for submissions is combined with the correspondence category — see `regulatory/fl-fda-correspondence/_context-commentary_regulatory-fl-fda-correspondence.md` regarding FloodLAMP's FDA engagement. Here are comments on the more technical aspects of the EUA submission process.

The EUA submission process involves two main types of documents: the submission itself and the Instructions for Use (IFU). The submission is the regulatory document — it follows the FDA's structured template with sections covering purpose, measurand, intended use, device description, performance evaluation, manufacturing, and so on. The IFU is the operational document intended for the laboratories that will run the test. They overlap substantially in content, but serve different audiences and purposes. Both must be prepared and aligned, and both are substantial documents. For FloodLAMP, each test's submission ran 5,000–10,000 words, and each IFU ran 7,000–14,000 words.

A critical concept in understanding these documents is that the FDA authorizes test systems, not tests in isolation. The entire system — reagents from specific vendors, validated instruments, the exact workflow, controls, and interpretation criteria — is what receives authorization. Changing a single component can require revalidation. For open-source protocol tests like FloodLAMP's, this posed an inherent tension: the whole point was to enable broad deployment using commodity components from multiple suppliers, but the regulatory framework required specificity at every level. FloodLAMP addressed this by validating multiple instruments (QuantStudio 6 Flex, QuantStudio 7 Pro, Bio-Rad CFX96) and multiple primer and probe vendors (Eurofins Genomics, IDT, LGC Biosearch) within a single submission.

The bench science for EUA validation can actually move quite fast. In a conversation with another test developer — an academic who started a company during the pandemic and did obtain an EUA — they described doing the core validation work in a weekend. The bottleneck is not the assay work itself but the surrounding logistics and documentation. For FloodLAMP, the single biggest delay was getting registered with BEI Resources to obtain the cross-reactivity reagents. The FDA requires testing against a panel of related pathogens and respiratory flora, and BEI is the primary source for those reference organisms. The registration and shipping process takes weeks, and for a small organization running lean, that waiting period was a significant constraint.

Even with the FDA's templates available, the document preparation is a heavy lift for anyone who has not done it before. FloodLAMP benefited from other groups sharing their actual EUA submission documents — these are not published, and they differ in important ways from the public-facing authorizations and IFUs that appear on the FDA website. Having real examples was helpful for understanding the level of detail and the conventions that the templates alone do not fully convey. If the FDA allowed or facilitated sharing of these submissions, for example, by simply letting developers choose to publish their submissions openly, some likely would, especially academics. This would meaningfully lower the barrier for new entrants.
Even with the FDA's templates available, the document preparation is a heavy lift for anyone who has not done it before. FloodLAMP benefited from other groups sharing their actual EUA submission documents — these are not published, and they differ in important ways from the public-facing authorizations and IFUs that appear on the FDA website. Having real examples was helpful for understanding the level of detail and the conventions that the templates alone do not fully convey. If the FDA allowed or facilitated sharing of these submissions, for example, by simply letting developers choose to publish their submissions openly, some likely would, especially academics. This would meaningfully lower the barrier for new entrants.

The new capabilities of AI could transform the document preparation burden. The EUA submission and IFU are highly structured, repetitive across test types, and draw heavily on standardized language. With progress on standardization and transparency from the FDA — such as machine-readable templates, published example submissions, and clearer guidance on what constitutes acceptable variations — AI tools could handle much of the drafting, cross-referencing, and consistency-checking that currently consumes weeks of a developer's time. The combination of AI and regulatory modernization could significantly reduce the cost and time to bring validated, innovative tests to market.