The Association for Molecular Pathology (AMP), with clinical pathologist Dr. Michael Laposata, has filed a lawsuit to stop the U.S. Food and Drug Administration (FDA) from regulating laboratory developed tests (LDTs) as medical devices.
AMP suggested that the best path forward is to modernize Clinical Laboratory Improvement Amendments (CLIA) regulations, adding that CLIA reform would ensure continued development of accurate and reliable LDT procedures and for correct utilization, precise interpretation, and proper application of molecular test results. AMP cited draft legislation from November in its statement.
"LDTs are not manufactured, packaged, nor commercially distributed as medical devices," AMP noted. Importantly, Congress has not given FDA the authority to regulate LDTs as manufactured products, but instead delegated authority to the U.S. Centers for Medicare and Medicaid Services (CMS) to regulate these procedures as laboratory services under the Public Health Service Act, according to AMP.
"AMP remains very concerned about the wide-sweeping and long-lasting consequences the FDA rule will have for our members and patients across the country," said AMP president Dr. Maria Arcila as part of the announcement.
AMP's lawsuit is one of a string of protests to the FDA's final rule on LDTs announced April 29. Among the many points AMP made in the lawsuit filed August 19 in U.S. District Court for the Southern District of Texas are the following:
- Subjecting LDTs to the costs of FDA premarket approval (PMA) will be extraordinary. In 2025, for example, FDA medical device user fees for a 510(k), de novo classification, and PMA will increase to $24,335, $162,235, and $540,783, respectively. In addition, any change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process, or that would constitute a major change or modification in the intended use of the device, requires submission of a new 510(k) or de novo application.
- It typically takes the FDA far longer to complete review of a new device application than its goal dates suggest. In 2023, the FDA took up to 451 days, 437 days, and 458 days to review 510(k), de novo, and PMA applications, respectively.
- The final rule needlessly duplicates CLIA by subjecting laboratories to overlapping standards administered by different federal agencies.
- The final rule defies critically important exemptions of the federal Food, Drug, and Cosmetic Act (FDCA) that apply to healthcare providers in relation to device registration, recordkeeping, reporting, full inspection, and listing requirements. The final rule declares that otherwise exempted healthcare professionals are fully subject to the de novo and PMA pathways, according to the filing.
- The FDA rule threatens the ability of professionals in clinical laboratories, including many academic medical centers, reference laboratories, and community health systems across the country, to create, adapt, and modify LDTs to meet patients' needs, account for supply chain issues, reflect advances in scientific understanding and practice standards, and improve performance characteristics, according to AMP.
"AMP will continue working with key stakeholders to develop a more effective and efficient legislative framework that ensures high-quality patient care while continuing to foster rapid innovation and the promise of new diagnostic technologies," Arcila added.
Although Laposata is an employee of the state of Texas, he brought the lawsuit in his personal capacity as a practicing medical doctor and clinical pathologist, according to the filing. Laposata currently serves as chairman of the department of pathology at the University of Texas Medical Branch-Galveston.
As of August 14, Stage 1 of the FDA's new policy for LDTs was still set to begin May 6, 2025.
