FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing

Lexology October 15, 2025
Womble Bond Dickinson (US) LLP

Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that. Multiple lawsuits were brought against the FDA and consolidated before a district court in the Eastern District of Texas. The impetus behind the lawsuits were claims that treating LDTs as devices requiring FDA approval would create “massive compliance costs.” Plaintiffs argued that LDTs were not devices, but services which are not subject to FDA regulation. The district court agreed:

Although the FDCA’s text alone is enough to conclude that FDA lacks authority to regulate laboratory-developed test services as medical “devices,” see supra Part IV.B, the broader statutory framework...

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