Federal judge upholds FDA authority over lab-developed tests
A U.S. federal judge has ruled that the Food and Drug Administration (FDA) possesses the authority to regulate lab-developed tests (LDTs) as medical devices. This decision comes amid ongoing debates over the oversight of in-house diagnostic tools used by clinical laboratories.
In a ruling issued in late September 2024, U.S. District Judge Matthew J. Kacsmaryk in the Northern District of Texas affirmed the FDA's longstanding position that LDTs fall under the definition of medical devices subject to federal regulation. LDTs are diagnostic tests designed, manufactured, and performed within a single laboratory, often customized for specific needs but not always cleared through the FDA's premarket review process.
The case, Association for Molecular Pathology v. FDA, stemmed from a 2023 lawsuit filed by the American Clinical Laboratory Association (ACLA) and other groups challenging the FDA's 2024 proposed rule to phase in oversight of LDTs. The plaintiffs argued that LDTs are services rather than devices and that regulating them would stifle innovation and increase costs. However, Judge Kacsmaryk rejected these claims, stating in the opinion, 'The FDCA [Food, Drug, and Cosmetic Act] defines a device to include articles intended for use in diagnosis... LDTs plainly fit this definition.'
This ruling aligns with the FDA's efforts to address risks associated with LDTs, particularly after high-profile failures like the inaccurate COVID-19 tests during the pandemic. The agency has cited data showing that some LDTs lack rigorous validation, potentially endangering patients. For context, the FDA estimates there are over 3,000 labs offering more than 2,000 LDTs in the U.S., many in areas like oncology and genetics.
Industry stakeholders have mixed reactions. The ACLA expressed disappointment, warning that full enforcement could 'devastate access to vital testing.' Conversely, patient advocacy groups like the AIDS Institute praised the decision, noting it 'protects public health by ensuring tests are safe and effective.' The ruling does not immediately alter current practices, as the FDA's rule includes a four-year phase-in period starting in 2024, but it paves the way for stricter compliance requirements.
Broader implications include potential increases in testing costs and delays in bringing new diagnostics to market, affecting healthcare providers and patients reliant on personalized medicine. The decision may face appeals, keeping the issue in the courts as policymakers balance innovation with safety.