Litigation Around Laboratory Developed Tests Starts in Earnest
Attorneys for the government and laboratory diagnostics trade groups gathered in court last week (February 19, 2025) to litigate a controversial federal rule that brings lab-developed tests (LDTs) under the remit of the FDA and its new proposed guidance. The American Clinical Laboratory Association (ACLA) has filed a lawsuit against the Food and Drug Administration (FDA), challenging a new rule that expands the FDA’s oversight of LDTs. The ACLA argues that the FDA does not have the authority to regulate these tests as medical devices, and that this responsibility should fall under the Centers for Medicare and Medicaid Services. This legal battle is significant as it could set a precedent for how much regulatory power the FDA has over lab-developed tests in the future. Whatever the outcome of this legal challenge, it is unlikely to be resolved before the rule’s new Phase 1 requirements go into effect on May 6, 2025 (for information on the FDA’s final rule, see our whitepaper here).
The FDA has proposed a comprehensive regulatory framework to oversee laboratory-developed tests. The FDA has amended its regulations to explicitly classify LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. This means LDTs will be subject to the same regulatory controls as other in vitro diagnostics (IVDs). This regulatory shift aims to enhance patient safety by ensuring LDTs meet the same stringent standards as other medical devices and diagnostics in healthcare settings by subjecting them to a more rigorous premarket review process. It requires manufacturers to register the tests with the FDA and report adverse events. The FDA contends that the risks associated with LDTs have increased, necessitating stricter oversight. The FDA plans to phase out its general enforcement discretion approach over four years. This phased approach will gradually increase laboratory compliance requirements, allowing them time to adapt to the new regulations.
The first stage of the FDA’s regulation of laboratory-developed tests (LDTs) involves several key requirements that laboratories must comply with by May 6, 2025 (see here for more information). For our clients to come into compliance with Phase 1 by the deadline, we recommend the following:
- Perform gap and risk assessments and implement remedial actions, including the following compliance aspects: Medical Device Reporting requirements, correction and removal reporting requirements, and Quality Systems requirements.
- Prepare the quality system to meet requirements under § 820.198 (complaint files). 3. Handle complaint files and follow quality system regulations to ensure that any issues with their tests are properly documented and addressed.
- Companies should report significant adverse events related to their LDTs to the FDA (Medical Device Reporting (MDR)). This helps the FDA monitor and identify problematic tests in the market.
- Report any corrections or removals of LDTs necessary to reduce a risk to health or remedy a violation of the FD&C Act.
Aware that the deadline for Phase I compliance is less than three months away, U.S. District Court Judge Sean D. Jordan promised a summary judgment “soon.” This is a fast-moving and complex issue for the laboratory industry, and we will continue to monitor the situation.
Do you need help with the new LTD rule compliance? We will provide more information on this guidance in upcoming posts. In the meantime, please reach out by email at info@labshire.com or call +1 844-686-5750 if you need our experts to assist with your development needs.
For more information on the litigation and the trial, please see our colleague Christine P. Bump’s excellent article here.
#ldt #lab #laboratory #medicallab #clia #fda #finalrule #ivd #compliance #healthcare #biopharma #lifesciences #labshire #blog #consultant #laboratorydevelopedtest
