3-Minute Brief: Key Updates on the Lawsuits Challenging FDA’s LDT Final Rule After Oral Arguments
Long story short: the judge heard oral arguments and promised a summary judgment would be coming "soon."
Yesterday, Judge Sean D. Jordan of the District Court for the Eastern District of Texas heard oral argument in the consolidated suits against the FDA regarding the final rule to regulate laboratory-developed tests as medical devices.
If you haven’t followed the legal story, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) sued the FDA over its final rule classifying LDTs as medical devices. They argue that the FDA lacks the authority to regulate LDTs, which they consider professional services rather than tangible products subject to device regulation.
The plaintiffs seek to vacate the rule and prevent enforcement. The judge said he would issue a summary judgment “soon,” acknowledging that the Stage 1 deadline is approaching.
Christine Bump of Penn Avenue Law & Policy wrote an excellent summary of yesterday's events in court. Read it here on LinkedIn for all the details:
We’ve distilled her report into a 3-minute takeaway summary below.
Key issues and arguments
The ACLA and AMP argue that LDTs are not physical products but rather processes used to analyze biological samples for patient care, meaning they should not fall under FDA regulation. In contrast, the FDA asserts that LDTs are simply a subset of in vitro diagnostic devices (IVDs), which have always been subject to the agency’s oversight. The core of the legal debate is whether LDTs fit the FDCA’s definition of a "device," which includes "articles" used in disease diagnosis. ACLA and AMP contend that LDTs are not "articles" or "contrivances" since they are not manufactured or sold, whereas the FDA counters that LDTs could be physically packaged and distributed if labs chose to do so.
From a legislative standpoint, the plaintiffs argue that Congress never intended for the FDA to regulate LDTs, as demonstrated by the history of the FDCA and the Clinical Laboratory Improvement Amendments (CLIA). They highlight that the 1976 Medical Device Amendments and subsequent updates to CLIA did not give FDA explicit authority over laboratory-developed tests. However, the FDA maintains that it has had regulatory authority over all laboratory tests since 1938, with the Medical Device Amendments reinforcing this position.
The rule's broader impact is also a key point of contention. ACLA and AMP warn that compliance costs—projected at $115 billion upfront and $14.5 billion annually—will severely limit access to essential diagnostic tests, particularly for rare diseases and pediatric care. The FDA argues that the final rule strikes a necessary balance between safety, innovation, and accessibility.
Major questions doctrine and court proceedings
The "major questions doctrine" was debated, with AMP arguing FDA’s decision represents a “major” economic policy shift requiring explicit congressional approval. FDA disagreed, claiming its authority has always been clear. Judge Sean D. Jordan showed deep engagement with statutory definitions, legislative history, and the economic burden. He repeatedly pressed both sides on their interpretations and surgical analogies used in arguments.
A decision is expected “soon,” as Judge Jordan acknowledges the urgency of the May 6, 202, deadline for the first stage of compliance with the Final Rule, which we recently explained in detail:
We will closely monitor the upcoming court ruling, as it will determine whether labs must comply with FDA medical device regulations or continue operating under the current CLIA framework.
If the FDA's rule is upheld, firms will face significant regulatory burdens, including premarket review, compliance costs, and potential limitations on test development. If the rule is vacated, laboratories can maintain their current operations, but ongoing legal and legislative challenges may still shape the future regulatory landscape.
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