On March 31, 2025, a U.S. District Court ruling vacated the FDA’s Laboratory Developed Tests (LDT) Rule, raising key questions about the future regulation of lab tests and in vitro diagnostics.
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled to vacate the FDA’s final LDT Rule in the case American Clinical Laboratory Association v. FDA. The LDT Rule would have required laboratories offering LDTs to comply with medical device requirements. The rule also phased out the FDA's enforcement discretion policy, with active enforcement set to begin on May 6, 2025. Judge Jordan found that the FDA lacked authority to regulate LDTs under the current definition of “device” in the Food, Drug, and Cosmetic Act, a conclusion reinforced by Congress’ passage of the 1988 Clinical Laboratory Improvement Amendments (CLIA) and failure to pass the VALID or VITAL Acts.
The Laboratory Developed Test (LDT) Rule was introduced by the FDA to regulate laboratory-developed tests under the framework of medical device requirements. The rule aimed to bring LDTs, which are tests created and used within a single laboratory, under the same regulatory standards that apply to other medical devices. This included mandatory premarket reviews and compliance with FDA standards. The goal was to ensure that LDTs meet safety and efficacy requirements similar to those of diagnostic devices already regulated by the FDA. However, the rule faced pushback from laboratories and stakeholders, who argued that LDTs should remain outside of FDA oversight due to their unique nature and the complexity of applying medical device regulations to them.
In the ruling, Judge Jordan explained that the term “device” in the Food, Drug, and Cosmetic Act applies only to tangible, physical products and does not extend to the services provided in LDTs. The decision showed the distinction between physical devices, like software embedded in hardware, and the services provided by labs. Judge Jordan referenced the 2007 Microsoft v. AT&T decision to emphasize that "software" as a product is distinct from the service-oriented nature of LDTs.
Laboratory Developed Tests (LDTs) are diagnostic tests developed and used within a single laboratory, making them different from commercially available diagnostic devices. LDT regulation has been a contentious issue, with stakeholders debating the scope of FDA authority and the potential costs to healthcare providers.
This decision is important for LDT regulation because it challenges the FDA's authority to impose medical device requirements on laboratory-developed tests. By vacating the LDT Rule, the court has essentially ruled that LDTs do not fall under the FDA's definition of a medical device, which could limit the agency's ability to enforce stricter oversight on these tests. This ruling leaves the future of LDT regulation uncertain, as it may push the FDA to reconsider its approach and could result in legislative action to clarify the role of federal agencies in regulating laboratory tests. With the use of LDTs in clinical practice, this decision impacts how these tests will be monitored for safety and accuracy, potentially creating a gap in regulatory oversight.
The court’s decision to vacate the FDA’s LDT Rule displays the need for clearer legislative direction on how laboratory tests should be regulated. As the FDA navigates its next steps, labs must remain prepared for potential future changes in both federal and state-level regulations.
The LDT Rule was introduced by the FDA to regulate laboratory-developed tests under the same medical device requirements as commercial diagnostic devices.
The FDA aimed to ensure that LDTs meet safety and efficacy standards similar to those of other diagnostic devices to protect public health.
The court's decision vacated the LDT Rule, ruling that LDTs are not considered medical devices under the current legal framework, leaving the future of their regulation uncertain.
The court concluded that the term "device" applies only to tangible, physical products, excluding the services provided by laboratories in developing and running LDTs.
No, this decision specifically addresses LDTs, which are developed and used within a single laboratory and does not directly affect other types of in vitro diagnostic tests regulated by the FDA.