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The ACLA has sued the FDA over the agency’s final rule on regulation of lab-developed tests.

ACLA Sues the FDA Over Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

‘FDA’s final rule is the wrong approach’ for LDTs, ACLA president says

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Scott Wallask, BA
Photo portrait of Scott Wallask

Scott Wallask, BA, is senior editorial manager for Today’s Clinical Lab and G2 Intelligence. He has spent more than 25 years covering the healthcare and high-tech industries. A former newspaper reporter, he graduated from Northeastern University with a degree in journalism.

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Published:May 30, 2024
|2 min read
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The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, filed a lawsuit on May 29 against the U.S. Food and Drug Administration (FDA) over the agency’s recent final rule to regulate laboratory-developed tests (LDTs) as medical devices. 

The suit was filed in U.S. District Court for the Eastern District of Texas, according to the ACLA. Ever since the FDA released a proposed version of the rule in the fall, industry observers largely expected one or more groups to challenge the rule in court.

The final rule, which has been years in the making, sets a series of deadlines starting in 2025 for review of LDTs by the FDA. Many clinical labs and industry groups oppose the rule given the major changes they face—a stark contrast to a long period of prior enforcement discretion by the FDA that kept LDT regulation less intense.

“For years, ACLA has worked collaboratively with Congress, FDA, and other stakeholders to develop legislation that would establish an appropriate regulatory framework for diagnostics,” the ACLA said in a statement. “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.”

 Susan Van Meter, ACLA’s president, also criticized the rule in a statement.

“FDA’s final rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” Van Meter said. “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,” she continued. “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.”

ACLA stated it would rather see LDT oversight accomplished through legislation that involves discussion with Congress, the FDA, and industry representatives.

It remains to be seen whether other groups will file additional lawsuits against the FDA. The Association for Diagnostics & Laboratory Medicine’s president, Octavia Peck Palmer, PhD, FADLM, told Today’s Clinical Lab in a recent interview that her organization “is considering all options as it reviews the rule.”