METADATA
last updated: 2026-03-01 RT
file_name: _context-commentary_regulatory-ldts.md
category: regulatory
subcategory: ldts
words: 674
tokens: 947


CONTENT

## Context
The FloodLAMP test was never used as an LDT. Our pilots operated under surveillance (see archive folder regulatory/surveillance), and we submitted to the FDA for IVD EUA. We had discussions with UnitedHealth Group about a clinical lab network adopting our direct LAMP test as an LDT, shared all of our information (data, FDA submissions, cost model, etc.), but they did not move forward with the project.

As a background explainer, Laboratory-developed tests (LDTs) are in vitro diagnostic tests that are designed, manufactured, and used within a single clinical laboratory, as opposed to commercial IVD test kits produced by diagnostic manufacturers and sold to laboratories across the country. Commercial IVDs are subject to FDA premarket review under the medical device classification system, while LDTs have historically operated under FDA "enforcement discretion," meaning the agency asserted jurisdiction but generally chose not to enforce device requirements. This distinction created a bifurcated market: commercial diagnostic products held to rigorous FDA analytical and clinical validation standards, and laboratory-developed tests for the same purposes that were primarily overseen through CMS under the Clinical Laboratory Improvement Amendments (CLIA). The tension between these two regulatory tracks became a central issue during the COVID-19 pandemic and in the years that followed.

The JD Supra article by Skadden Arps attorneys (October 2020) provides a useful overview of the decades-long history of LDT regulation, tracing FDA's evolving posture from initial enforcement discretion through the 2010 public workshop, the 2014 draft guidance, the 2017 retreat to Congress, and the COVID-era policy reversals. It remains a good starting point for understanding the regulatory backdrop against which COVID-era LDT policy played out.

Two AI-generated reports in this subcategory provide more detailed analysis. The first, "FDA, LDTs, and COVID-19: Interactions, Policy Shifts, and Key Issues (2020-2023)," is a detailed synthesis of how FDA oversight of COVID-19 LDTs moved through three distinct phases: initial EUA-based enforcement discretion, the August 2020 HHS policy blocking mandatory premarket review, and FDA's restoration of an EUA-first posture after November 2021. The second, "FDA 2024 LDT Rule - Status and Legal History," covers the post-pandemic attempt by FDA to formally end broad enforcement discretion for LDTs through rulemaking, the subsequent legal challenge, the March 2025 court vacatur, and FDA's decision not to appeal, which returned LDT oversight to the pre-2024 status quo.

Related regulatory subcategories in this archive include: FDA Policy (`regulatory/fda-policy/`), which covers broader FDA regulatory actions and user fee frameworks; FDA Town Halls (`regulatory/fda-townhalls/`), which documents the weekly public calls FDA held with COVID-19 test developers; Surveillance (`regulatory/surveillance/`), which covers the surveillance testing framework under which many LDT-based programs operated; and Open EUAs (`regulatory/open-euas/`), which addresses the question of whether FDA should have made EUA pathways more accessible to LDT developers and smaller laboratories.


## Commentary
LDT regulation is deeply interconnected with FDA testing policy. As the AI report on COVID-era LDT oversight documents in detail, the FDA went back and forth during the pandemic on whether LDTs needed EUA authorization, with HHS at one point blocking mandatory premarket review entirely and FDA later restoring an EUA-first posture. Underlying these policy swings is a structural gap in the regulatory framework: there is no middle ground between laboratory-developed tests, where a single lab has broad authority to develop and use a test internally, and commercial IVDs produced by manufacturers who contract with reagent companies to produce kits sold to laboratories nationwide (or direct to consumers for at-home devices). This gap became acutely problematic during the pandemic, when the need to rapidly scale testing demanded something between the two models. A promising solution emerged in the form of the Open EUA, pioneered and authorized during the pandemic by the SalivaDirect program under Dr. Anne Wyllie, which allowed multiple laboratories to adopt and run a validated protocol under a shared authorization, overseen and managed by a responsible party (which became a nonprofit). Unfortunately, the Open EUA concept was not further developed by FDA or the field, and it remains an underexplored pathway.

For fuller commentary on LDTs, FDA policy, and Open EUAs, see `regulatory/open-euas/_context-commentary_regulatory-open-euas.md`.