Federal judge thwarts FDA's move to govern Laboratory-Developed Tests; wondering about the subsequent course of action.
In a significant legal setback, the Food and Drug Administration (FDA) no longer exercises formal regulatory oversight over Laboratory Developed Tests (LDTs) as medical devices, as of mid-2025. This follows a federal court ruling in Texas that vacated the FDA’s 2024 final rule aimed at bringing LDTs under the agency’s regulatory framework [1][3][5].
The court ruled that the FDA lacked statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate LDTs as medical devices. Consequently, Clinical Laboratory Improvement Amendments (CLIA)-certified labs can continue to offer LDTs without FDA clearance or approval [1][3]. This means LDTs remain primarily regulated by CLIA, not the FDA.
The FDA, however, has not appealed the court order and has chosen to step back for now, signalling a possible future re-engagement but no immediate action [1][3]. The agency may pursue revised rules, new guidance, or targeted enforcement in the future. Nevertheless, congressional action to grant explicit FDA authority over LDTs appears unlikely in the current political environment [1][3].
The industry's impact is such that labs continue to operate under CLIA regulations, with FDA enforcement discretion continuing. Stakeholders are keeping a close eye on policy shifts and new FDA initiatives [1][3]. Some experts suggest that state regulators could step in to help fill the void, as New York and Washington already have the infrastructure for regulating many aspects of lab operations [1].
LDTs are commonly used by most labs to meet specific clinical needs, where commercial in vitro diagnostic tests are unavailable [1]. The decision not to appeal the court order was met with speculation that the FDA may wait for either activity from Congress or the next administration before revisiting the issue [1].
Advocates argue that having two different tests for the same patient regulated by two different regulatory programs is inefficient and not in the public's best interest [1]. They urge Congress to decide how LDTs should be treated. However, recent attempts to reform the regulatory framework for In Vitro Diagnostic (IVD) tests, like the Verifying Accurate, Leading-edge IVCT Development Act, have failed to gain traction in Congress [1].
As the FDA considers its next steps, one area to watch is whether they begin actions toward products previously not targeted for active enforcement [1]. Attorneys predict that at some point, a renewed legislative effort to modernize regulation of diagnostic testing and clarify the FDA's role in LDT oversight is likely [1].
References: [1] Goodwin, Matt Wetzel, "FDA's LDT Final Rule Vacated: What's Next?," FDA Law Blog, May 2025, [3] AdvaMedDx, "FDA's LDT Final Rule Vacated: What's Next?," AdvaMedDx Insight, May 2025, [5] Hyman, Phelps, Gibbs, "FDA's LDT Final Rule Vacated: What's Next?," Hyman, Phelps, Gibbs, May 2025,
- The vacated final rule by the FDA in 2024 aimed at regulating Laboratory Developed Tests (LDTs) as medical devices has led to an analysis of the future of medtech diagnostics and analytics in healthcare.
- The court ruling stated that the FDA lacked the necessary statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate LDTs as medical devices, which means these devices are primarily regulated by Clinical Laboratory Improvement Amendments (CLIA), not the FDA.
- Amidst this regulatory shift in health-and-wellness, the industry is keeping a close eye on policy changes and new FDA initiatives that could impact medtech devices and patient care.
- Experts in the field suggest that state regulators could potentially fill the void left by the FDA, with states like New York and Washington already having the infrastructure to regulate lab operations.
- LDTs are commonly used in labs to diagnose medical-conditions where commercial in vitro diagnostic tests are unavailable, making their regulation crucial for overall healthcare delivery.
- The Agency for Healthcare Research and Quality (AHRQ) has reported that LDTs are used by most labs to meet specific clinical needs, and this shift in regulation could have far-reaching implications for their use in the future.
- The failure of recent attempts to reform the regulatory framework for In Vitro Diagnostic (IVD) tests, like the Verifying Accurate, Leading-edge IVCT Development Act, underscores the complexity of legislative action regarding AI in diagnostics and the need for a cohesive approach.
- As the FDA considers its next steps, it is essential for policymakers and stakeholders alike to prioritize patient safety and consider the broader implications of this regulatory change on health-and-wellness, medtech, and the future of diagnostic testing.
