FDA’s LDT oversight faces an uncertain future, experts say

The future of the US Food and Drug Administration’s (FDA) involvement with laboratory-developed tests (LDTs) seems uncertain in the wake of a recent federal court case that successful overturned the agency’s final rule that would have treated most LDTs as medical devices, experts argued in a recent special communication published in JAMA Health Forum.

While FDA has had oversight of in vitro diagnostic tests since 1976, the agency and US lawmakers have been largely unsuccessful in their efforts to regulate LDTs as they have encompassed a growing number of clinical areas. The US Congress has introduced the Verifying Accurate Leading-edge IVCT (In Vitro Clinical Treatment) Development (VALID) Act over several years that would grant FDA statutory oversight of diagnostic technologies, including LDTs, but the VALID Act has never been passed into law.

FDA issued a final rule in 2024 after years of debate with stakeholders that would have made the tests subject to the regulatory requirements of medical devices. Critics of the move, such as the American Clinical Laboratory Association (ACLA), claimed that the clinical laboratories already have their own regulatory oversight, and that FDA oversight would be overly burdensome. (RELATED: FDA issues long-awaited LDT final rule, Regulatory Focus 29 April 2024)

ACLA, the Association for Molecular Pathology, and other plaintiffs sued the agency, and successfully won a federal court case in American Clinical Laboratory Association et al v FDA et al, which ordered FDA to vacate the final rule. However, this court decision does not solve the underlying problems with oversight of LDTs, Kushal Kadakia, MD, of Harvard Medical School, and colleagues said.

“The outcome of ACLA v FDA does not close the door to regulatory reforms but rather resets the table for debate as to how regulatory frameworks can be adapted over time to keep pace with technological advances,” Kadakia and colleagues wrote.

While FDA’s role in regulating LDTs has been restricted through the court decision, it “simply preserved the status quo, as the FDA’s preexisting posture of enforcement discretion meant that LDTs were frequently being marketed without clinical or regulatory oversight,” the authors said.

This decision could also exacerbate an existing issue where manufacturers skirt the agency’s premarket review process by claiming their products are LDTs and therefore outside FDA’s purview, Kadakia and colleagues explained. “In other words, the court’s logic not only removed the FDA from LDT regulation but also undermined the FDA’s existing regulation of diagnostic devices,” they said.

Implications for public health

Citing the recent decision by the US Supreme Court to overturn the Chevron doctrine, the federal court’s decision noted that FDA did not have the authority to regulate LDTs unless they were granted Congressional authorization. (RELATED: Experts: Chevron deference ruling could impact recent FDA regulations, Regulatory Focus 2 July 2024)

Since FDA seems “unlikely to appeal the court’s decision,” the authors noted, it could have implications for reform through administrative action and for the agency’s regulatory authority over other areas outside of LDTs.

“The FDA’s delicate task has always been determining how Congress’ general regulatory frameworks can be adapted to protect patients and the public’s health amid the constant evolution of health technologies. However, as ACLA v FDA demonstrates, courts may be increasingly skeptical of the FDA’s interpretation of its authority following Loper Bright Enterprises v Raimondo,” Kadakia and colleagues wrote.

“The potential consequences for public health are bidirectional: the risk of a chilling effect on the FDA’s ability to engage in proactive regulatory activities and the risk of new challenges to existing FDA regulations of medical products,” they explained.

Ultimately, any change to how LDTs are scrutinized will significantly impact the laboratory industry and the practice of medicine, Kadakia and colleagues said, because “LDTs are universally embedded into clinical care today.”

“Forging a path forward will therefore require accounting for multiple stakeholder perspectives and navigating the interplay among congressional statutes, administrative action, and judicial precedent,” the authors concluded.

JAMA Health Forum Kadakia et al.

FDA’s LDT oversight faces an uncertain future, experts say

Related topics

Recommended content

Welcome to the new RAPS Digital Experience