In May 2024, the decades-long debate between the FDA and CLIA program over regulation of LDTs, seemingly came to an end with the publication of an FDA final rule, making it explicit that IVDs are classified as devices under the FD&C Act, including when the manufacturer of the IVD is a laboratory (i.e., LDT). This new rule formalized FDA’s oversight of LDTs, which have historically been regulated through CLIA under CMS. However, based on the AMP and ACLA lawsuits urging the courts to vacate the final rule, based on and claiming an overstep in FDA authority, the debate over regulatory control of LDTs is likely far from over. On January 23, the oral argument date for the lawsuits against the FDA was set for February 19, signaling the potential for a ruling prior to the Stage 1 May 6 implementation deadline, requiring LDT manufacturers to meet select MDR requirements.
In October 2024, key societies including the AAB, NILA, ASCP, ADLM, ASM and IDSA filed an Amicus Brief in support of the AMP and ACLA lawsuits. Similar to the argument made by AMP and ACLA, the brief indicates the FDA is overstepping its authority and addresses concerns of disproportionate impact these new regulations will have on community or regional laboratories with ‘niche specialties’, hindering innovation and access to necessary testing. Similarly, in letters addressed to the co-chairs of the Trump transition team, CAP and the ASCP urged the incoming administration to rescind the FDA LDT final rule, citing concerns that the rule would limit patient access, referencing the 2020 decision made by US HHS Secretary Alex Azar to block the FDA from regulating LDTs.
With the court’s decision and May 6, 2025 Stage 1† deadline looming, many questions remain. Will either side appeal if the case is upheld or overturned? Will Congress enact additional reform or legislation before a decision is reached? How well Is the FDA currently equipped to regulate LDTs based on staffing and infrastructure? What impact will this regulatory change have on access to testing and innovation? What financial impact will this have on LDT manufacturers?
With the potential of the FDA final rule being upheld, the regulatory and market access landscape for LDTs in the US could be changing. Manufacturers may be forced to consider alternative business strategies, including consolidation or acquisition.
BeaconOne is actively tracking and engaging in the evolving US and O-US policy and reimbursement landscape for laboratory services. Contact us to learn more about our global capabilities.
†Stage 1 requirements: FDA will require compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files. Subsequent stages will be rolled out over a 4-year period; Stage 2, May 2026, Stage 3, May 2027, Stage 4, Nov 2027, Stage 5, May 2028
AAB: American Association of Bioanalysts; ACLA: American Clinical Laboratory Association; ADLM: Association for Diagnostics & Laboratory Medicine (ADLM); AMP: Association of Molecular Pathology; ASCP: American Society for Clinical Pathology; ASM: American Society for Microbiology; CAP: College of American Pathologists; CLIA: Clinical Laboratory Improvement Amendments; CMS: Center for Medicare & Medicaid Services; FDA: Food and Drug Administration; FD&C Act: Federal Food, Drug, and Cosmetic Act; HHS: Health and Human Services; IDSA: Infectious Disease Society of America, IVDs: in vitro diagnostics; LDTs: laboratory developed tests; NILA: National Independent Laboratory Association