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On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs).
The court’s judgment vacates the agency’s controversial final rule of May 6, 2024 (the “Final Rule”), regulating LDTs as medical devices, just weeks before the Final Rule’s initial implementation deadline and remands the issue back to the FDA for further consideration.
Key Takeaways
- Implementation of the Final Rule would have imposed major burdens on many laboratories that will now no longer apply.
- Manufacturers and distributors of laboratory reagents and equipment may be subject to FDA enforcement.
- The FDA and the Centers for Medicare & Medicaid Services have collaborated to align their roles in the regulation of LDTs, as highlighted in their joint statement.
- Despite recent developments, questions persist regarding whether updates or revisions to the current regulatory framework for LDTs will be issued.
- Any regulatory updates could have significant implications for stakeholders in the diagnostics and health care sectors, emphasizing the need for continued vigilance and compliance. Epstein Becker Green is dedicated to keeping clients informed and equipped to navigate potential changes in the regulatory landscape for LDTs.
For more information on the Final Rule, read "The LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold."
