A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency overstepped its authority and that LDTs should be treated more as an intangible process than a tangible product.
The ruling was issued for a pair of consolidated lawsuits brought against the FDA last year by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), plus their members, after the agency put forward its finalized text in late April 2024. The judge vacated the rule in its entirety.
“AMP is extremely pleased with the court’s clear and decisive ruling in our favor, and we hope this will finally end the FDA’s attempts to exert an unwarranted overreach of authority of LDTs,” the association’s president, Jane Gibson, Ph.D., said in a statement. “The decision to vacate the FDA rule will avoid adding billions of dollars to healthcare costs and protect access to high-quality care for hundreds of millions of Americans.”
“The court’s ruling ensures that clinical laboratories can continue to focus on their primary mission—offering innovative and reliable diagnostics that save and improve the lives of millions of patients every day,” said ACLA President Susan Van Meter. “This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country.”
The FDA’s regulation had proposed a multiyear timeline that would have phased in reviews and other requirements for LDTs through 2028—while offering exemptions for tests manufactured and performed within a single health system as well as those approved by state-level evaluation programs.
The agency had said that LDTs and in vitro diagnostics have always been considered medical devices under the Federal Food, Drug & Cosmetic Act, which grants the FDA its regulatory authority—but that the agency had previously made allowances for the category, which for decades had been considered to carry low risks for patients, due to their use in small volumes with common lab equipment.
However, in recent years the FDA has said LDTs have gained both nationwide reach and technical complexity and that the diagnostics industry has come to view LDTs as a path to an initial commercial rollout prior to subjecting a test to full federal review—including genetic tests, for example, to evaluate cancer patients for tumors with specific DNA mutations.
The agency said that with about 70% of all medical decisions being based on diagnostic test results, it would be necessary to ensure the effectiveness of LDTs in the same manner as other in vitro kits sold by manufacturers.
In his summary judgement ruling for the ACLA and the AMP, the Eastern Texas district judge said Congress created a separate certification framework for laboratory test services, known as CLIA, and that LDTs should instead fall under that category.
“Unlike a drug or device, which is a manufactured and packaged article of commerce with user instructions, a laboratory-developed test service is a proprietary methodology performed by only the developing laboratory,” Judge Sean Jordan wrote in his opinion. “The testing service is not sold as a kit, and the protocol is not transferred in any manner to other laboratories, hospitals, or other facilities outside the developing laboratory entity. No physical product is sold, and no article of personal property is transferred such that title passes from one party to another.”
“CMS is primarily responsible for administering CLIA, and in that role it has issued extensive implementing regulations,” Jordan added. “CLIA and its regulations reflect that performing and interpreting laboratory tests requires significant scientific and technical knowledge, training, experience, and judgment. In this regard, the laboratory testing process is different from manufacturing devices.”
The judge also cited estimates that the FDA’s final rule would cover about 80,000 existing tests from more than 1,100 laboratories, and would include about 10,000 new tests each year—and that the agency has forecast it would need to review “an additional 103 premarket applications, 1,090 premarket notifications, and 267 de novo classification requests each year.”