May 29, 2024—The American Clinical Laboratory Association and its member company, HealthTrackRx, filed a lawsuit today against the U.S. Food and Drug Administration in the U.S. District Court for the Eastern District of Texas, challenging the agency’s May 6 final rule, which seeks to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetic Act.
The ACLA said in its press statement that it has worked with Congress, the FDA, and other stakeholders for years to develop legislation to establish an appropriate regulatory framework for diagnostics. Rather than continue that dialogue, the ACLA said, the FDA chose to act unilaterally and impose an ill-fitting device regime on laboratory testing services.
ACLA president Susan Van Meter said that the FDA’s final rule is the “wrong approach, both as a matter of law and public policy,” and represents regulatory overreach. “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.”
The ACLA maintains that legislation is the right, and only, approach for the FDA to regulate professional testing services offered by laboratories.