ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices
Washington, D.C. – Today 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 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).
For years, ACLA has worked collaboratively with Congress, FDA and other stakeholders to develop legislation that would establish an appropriate regulatory framework for diagnostics. Rather than continue that dialogue, FDA chose instead to act unilaterally and impose an ill-fitting device regime on laboratory testing services. Given the far-reaching negative impacts on our nation’s laboratory community, ACLA 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,” said 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.”
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.
Below are links to ACLA’s previous statements, comments on the Proposed Rule, and testimony to Congress:
ACLA’s Statement on the Final Rule
ACLA’s Comments on FDA’s Proposed Regulation of Laboratory Developed Tests as Medical Devices
ACLA Statement on LDT Proposed Rule Comments by FDA and CMS
ACLA President to Testify on Regulation of Diagnostic Tests
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
