Summary: The American Clinical Laboratory Association and HealthTrackRx sued the FDA, arguing that the agency’s new LDT rule improperly classifies professional laboratory testing services as medical devices.


  1. ACLA contends that the FDA’s Final Rule exceeds its authority, as professional lab testing services should be regulated by CMS under CLIA, not as medical devices.
  2. ACLA President Susan Van Meter argues that the medical device framework is unsuitable for lab-developed tests, which are services provided by trained professionals.
  3. The lawsuit highlights concerns that the FDA’s rule could disrupt clinical laboratory services, negatively affecting patient care and the healthcare system.

The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the Eastern District of Texas, challenging the Agency’s May 6, 2024, Final Rule, which the association claims inappropriately seeks to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetics Act (FDCA).

“Congress has never granted FDA authority to regulate the professional testing services that laboratories provide, which are federally regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA),” the association says in a release.

FDA’s Final LDT Rule

ACLA says it believes it must bring this lawsuit to clarify that FDA’s Final Rule exceeds its authority. The lawsuit challenges the Final Rule because FDA has exceeded its statutory authority and acted arbitrarily and capriciously in violation of the Administrative Procedure Act.

“FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” says ACLA President Susan Van Meter. “The medical device framework is inappropriate and ill-suited for regulating laboratory-developed tests, which are services provided by trained professionals rather than manufactured products. These professional services incorporate the latest scientific advances to offer innovative testing solutions to physicians and the patients they serve. The Rule will disrupt this paradigm, creating negative consequences for the entire health care system, including millions of vulnerable patients who depend on the essential clinical testing services that only laboratory professionals can provide.”

Further reading: Senator Rand Paul Introduces Resolution to Repeal FDA’s LDT Final Rule

Significance of Lab Testing

Laboratory testing services are often created to address unmet patient needs. They provide patients and physicians with diagnostic information to inform clinical care, power precision medicine, contribute to the discovery of novel therapeutics, and lead the fight against emerging pathogens. Forcing them into the rigid regulatory framework designed for manufactured medical devices will undermine the dynamic and patient-centered nature of clinical laboratory services.

ACLA maintains that legislation is the right—and only—approach for FDA to regulate professional testing services offered by laboratories. The industry remains committed to working with Congress, FDA, and other stakeholders to advance appropriate legislation that preserves the critical role of laboratory diagnostics and ensures that patients continue to have access to lifesaving tests. 

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