On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the Food & Drug Administration's (FDA) rule on laboratory-developed tests (LDTs), halting the agency's enforcement plans scheduled to begin in May. This decision has significant implications for the clinical laboratory and healthcare industries regarding the legal oversight of these tests.
The court sided with laboratory industry plaintiffs, finding that the FDA lacks the authority to oversee LDTs under the Food, Drug, and Cosmetic Act (FD&C Act). The ruling vacates the FDA's proposed 2028 timeline for phasing in regulatory compliance, allowing U.S. clinical laboratories to continue incorporating LDTs without implementing new requirements such as medical device reporting.
U.S. District Court Judge Sean Jordan identified the Centers for Medicare & Medicaid Services (CMS) as the authority to administer CLIA and oversee LDTs. However, clinical laboratories and other industry stakeholders will monitor for further developments, as the FDA has 60 days to appeal, and U.S. Congressional involvement in determining LDT oversight remains possible. Exponent's expertise in medical devices and regulatory consulting positions it to advise clients on navigating this evolving landscape.
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