ACLA, AMP, Ask Federal Court To Strike Down FDA Rule Regulating Laboratory-Developed Tests

PLANO, Texas—The FDA’s final rule regulating laboratory-developed tests (LDTs) as medical devices is a broad and unprecedented change that upends a vital sector of healthcare to the serious detriment of patients, Ashley Parrish, an attorney representing the American Clinical Laboratory Association (ACLA), told a federal court on Wednesday.

The rule oversteps the FDA’s statutory authority, intruding into a field already governed by a comprehensive regulatory framework mandated by Congress, he said. If it is allowed to stand, some labs that are unable to fund the cost of FDA approval for LDTs will close. Others will offer fewer tests and innovation will stall, which Parrish said is “already starting to happen.”

“We are asking you to save us from the disastrous consequences of [the FDA’s] interpretation of its authority and strike down this rule,” he told U.S. District Judge Sean D. Jordan. Parrish’s remarks came during oral arguments on cross-motions for summary judgment filed by ACLA and the Association for Molecular Pathology (AMP) and by the FDA in a case that began on May 24, 2024, when ACLA filed a lawsuit challenging the FDA’s authority to regulate LDTs. AMP also sued the FDA, and the cases were later administratively consolidated.

ARUP Laboratories is a member of ACLA, and CEO Andy Theurer is a member of the association’s board of directors. Many of ARUP’s pathologists are also AMP members.

ARUP has made providing education about the FDA rule a priority and has advocated on behalf of clinical labs that oppose the new rule. ARUP and others in the industry anxiously await the outcome of Wednesday’s hearing as a May 6, 2025, deadline to comply with Stage 1 requirements of the FDA rule looms.

At the end of Wednesday’s 3 ½-hour hearing, the court indicated that it will review all parties’ briefs and their arguments and will make a decision soon. If the court decides in favor of ACLA and AMP, it could choose to vacate the rule, as the associations have requested. It could also accept the FDA’s request for additional briefing on an appropriate remedy.

In either case, the FDA could choose to appeal any decision made by the court in ACLA’s and AMP’s favor. However, that outcome is considered less likely under the Trump administration than it would have been had Trump not won the election. During Trump’s first term, then-U.S. Health and Human Services (HHS) General Counsel Robert Charrow blocked the FDA from regulating LDTs.

The FDA rule, which was published in the Federal Register on May 6, 2024, added 10 words to existing regulations to state that in vitro diagnostics (IVDs) manufactured by clinical laboratories—i.e., LDTs—are considered medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA explained that in making this change, it was seeking to subject LDTs to the same FDA premarket review and postmarketing requirements that apply to medical devices.

During Wednesday’s hearing, Parrish and Michael Shumsky, an attorney representing AMP, argued that the rule exceeds the FDA’s statutory authority because LDTs do not fit the definition of a device under the FDCA.

Parrish asserted that an LDT is a professional service, not a manufactured device, because it is a series of processes performed by highly trained professionals in a licensed and accredited facility using instruments and other tools to produce information for use by a clinician to treat a patient. A testing service results in a test result, not a device.

Parrish emphasized that Congress never gave the FDA authority to regulate laboratory testing services, but rather granted that authority to the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA) passed by Congress in 1967 and updated in 1988.

He argued that in the nearly nine decades since Congress passed the FDCA in 1938, the FDA has never asserted oversight of LDTs. For the FDA to now claim it has always had that authority and is just now choosing to enforce it “implies that entire generations of laboratory professionals who include doctors and doctoral scientists providing an essential service have been engaged in criminal activity,” he said.

The FDA’s novel interpretation of a nearly 90-year-old statute triggers the “major questions doctrine,” which requires agencies to point to congressional authorization for actions of major political and economic significance, according to Shumsky.

“The [FDA] has imposed a regime that will cost billions and harm patients,” he said.

Arguing for the FDA, attorney Gabriel Schonfeld disputed Parrish’s assertion that the FDA overstepped its statutory authority in seeking to regulate LDTs. He said that the FDCA grants the FDA broad authority, including over LDTs, which he defined as IVD test systems, not professional services.

According to Schonfeld, an LDT is an “apparatus” or “contrivance” and therefore qualifies as a device subject to regulation under the FDCA. In the FDA’s view, any time a laboratory uses one or more devices to perform a test procedure, it is manufacturing a new device that must be reviewed and approved by the FDA.

Schonfeld said the FDA chose to assert what he says is its long-held authority with the new rule because LDTs have become significantly more complex and their use has become more pervasive. The FDA argues it no longer serves the interest of public health to maintain different enforcement approaches for similar IVD test systems based solely on whether they are offered by a laboratory.

“The final rule is intended to better protect the public health by helping to ensure the safety and effectiveness of IVDs offered as LDTs,” he said.

Schonfeld added that the FDA believes that the major questions doctrine does not apply because the rule is “a case of federal regulation pursuant to unambiguous congressional authorization,” not an extraordinary one presenting major economic or political questions.

After the hearing ended, attorneys for ACLA said, “We appreciate the court’s time and look forward to a decision.”

Jonathan Genzen, MD, PhD, MBA, ARUP chief medical officer and senior director of governmental affairs, contributed a declaration to ACLA’s lawsuit and attended Wednesday’s hearing. He noted that he is grateful that the court granted ACLA and AMP the opportunity to express their profound concerns with the final rule during Wednesday’s hearing and that he, too, looks forward to a decision in this important case.

Genzen’s declaration on behalf of ARUP is available here.

Additional information and resources about the FDA rule can be found on this page at aruplab.com.

Lisa Carricaburu, lisa.carricaburu@aruplab.com