FDA's regulation of LDTs halted by court decision: Implications moving forward
The Food and Drug Administration (FDA) has decided not to appeal a federal court ruling that vacated its final rule regulating Laboratory Developed Tests (LDTs) as medical devices. This decision, made in March 2025, leaves the rule officially nullified, and no further federal court appeal or action on the order is currently underway or expected imminently.
Matt Wetzel, a partner at the Goodwin law firm, points out that New York and Washington already have the infrastructure for regulating many aspects of lab operations, suggesting that state regulators could potentially step in to help fill the void left by the FDA's halted regulation of LDTs.
The FDA's final rule, intended to strengthen oversight of LDTs, would have required adverse event reporting, premarket review, registration, labeling, and other provisions. However, the American Clinical Laboratory Association and the Association for Molecular Pathology sued to stop the FDA from enforcing the regulation, citing concerns about the high costs of compliance that might force labs to discontinue some test services.
The U.S. District Court for the Eastern District of Texas concluded that the rule exceeded the FDA's authority under the Federal Food, Drug, and Cosmetic Act of 1938. The court's opinion cited the Supreme Court's decision in Loper Bright Enterprises v. Raimondo in finding the FDA lacked the statutory authority to regulate LDTs as devices.
While the FDA's enforcement discretion approach to LDT regulation remains in effect, the regulatory landscape remains uncertain. The FDA may revisit LDT oversight at some point in the future with revised rules or new guidance.
Zach Rothstein, executive director of AdvaMedDx, emphasizes the need for Congress to decide how to treat LDTs, as having dual regulatory roles is not efficient and not in the public's best interest. A renewed legislative effort to modernize regulation of diagnostic testing and clarify the FDA's role in LDT oversight is likely at some point.
Barring a successful appeal, the battle shifts completely to Congress regarding the regulation of LDTs. The Verifying Accurate, Leading-edge IVCT Development Act, which aimed to reform the regulatory framework for In Vitro Diagnostic (IVD) tests, failed to gain traction in Congress despite multiple attempts.
Labs have continuously evaluated their test lists, and the work they put into preparing for the FDA's rule before it was halted is not considered completely useless. Ben Wolf, a partner at Alston & Bird, stated that industry should feel good about not having to comply with the FDA requirements for now.
The FDA argues that more active oversight is needed for LDTs due to greater risks associated with modern versions of the tests. However, any comment or response to the court's opinion from the FDA could be slowed by recent cuts to FDA staff, including in the communications department.
As the FDA considers its next steps, it might focus on products previously not targeted for active enforcement. In the meantime, LDTs are regulated under the Centers for Medicare and Medicaid Services' Clinical Laboratory Improvement Amendments program, as established by Congress.
Sources:
- MedTech Dive
- Reuters
- STAT News
- Fierce Biotech
- The FDA's halted regulation of Laboratory Developed Tests (LDTs) has left a regulatory void that state regulators, like those in New York and Washington, might fill due to their existing infrastructure.
- The FDA's final rule, intended to strengthen oversight of LDTs, required adverse event reporting, premarket review, registration, labeling, and other provisions, but was vacated by a federal court in 2025 due to exceeding the FDA's authority.
- The American Clinical Laboratory Association and the Association for Molecular Pathology opposed the FDA's regulation of LDTs, citing high costs of compliance as a concern.
- The Verifying Accurate, Leading-edge IVCT Development Act, which aimed to reform the legislative framework for In Vitro Diagnostic (IVD) tests, failed to gain traction in Congress, leaving the regulation of LDTs in a state of uncertainty.
- Matt Wetzel, a partner at the Goodwin law firm, suggests that state regulators could help fill the void left by the FDA's halted regulation of LDTs.
- Zach Rothstein, executive director of AdvaMedDx, emphasizes the need for Congress to decide how to treat LDTs, as having dual regulatory roles is not efficient and not in the public's best interest.
- Labs are reevaluating their test lists, with industry experts stating that the work they put into preparing for the FDA's rule before it was halted is not completely useless.
- With the FDA considering its next steps, it might focus on products previously not targeted for active enforcement, and LDTs are currently regulated under the Centers for Medicare and Medicaid Services' Clinical Laboratory Improvement Amendments program.
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