The LDT landscape after ACLA v. FDA
What the 2025 vacatur actually changed for public health laboratories, and why validation discipline is now the whole advantage.
What the court did
On March 31, 2025 the Eastern District of Texas vacated the FDA May 6, 2024 final rule that treated laboratory-developed tests as medical devices. The government did not appeal. In September 2025 FDA implemented the vacatur and reverted the IVD definition.
LDTs remain under CLIA, administered by CMS, not under the FDA device pathway. For a public health laboratory that must stand up an assay for H5, Oropouche, or an unknown etiology, that is operationally decisive.
What it did not do
It did not retire analytic validation, personnel competency, proficiency testing, or documentation. Flexibility without a quality system is still a survey finding, and it is still how a bad result leaves the building.
Legislative proposals (for example an Enhancing CLIA Act) may add transparency or third-party review later. As of mid-2026 the post-vacatur status quo holds. Plan against CLIA, not against a vacated phase-out calendar.
How Salus treats it
Every catalog entry and workbench outline is labeled decision support. Local validation and medical director authority remain mandatory. The platform's job is to make the packet faster to assemble and harder to forget, not to declare an assay live.
See it in your laboratory's context.
Explore the live demo, no login and no request form.