Osama Khan: A federal court has struck down the FDA’s attempt to regulate Laboratory-Developed Tests
Osama Khan, Staff Pathologist at Natera and Pathology network consultant for Path AI, shared a post on LinkedIn:
“Big News in Healthcare Regulation.
A federal court has struck down the FDA‘s attempt to regulate Laboratory-Developed Tests (LDTs)—a move with major implications for diagnostics, innovation, and regulatory authority.
For decades, LDTs—tests developed and used within a single lab—have operated under CLIA, not the FDA. Last year, the FDA tried to reclassify these as medical devices, imposing stricter oversight.
The court’s ruling? That the FDA overstepped. The judgment emphasized that Congress never intended the FDA to regulate these under the Federal Food, Drug, and Cosmetic Act (FDCA), and reaffirmed CMS’s oversight through CLIA.
Eric Q Konnick, the Association of Molecular Pathology (AMP) Professional Relations Committee Chair, said, “The FDA LDT rule would have created an undue burden on laboratories tasked with keeping patients healthy and safe, and would have led to extensive additional requirements in addition to the existing Clinical Laboratory Improvement Amendments (CLIA) regulations.”
Why this matters:
- Protects innovation in diagnostic labs.
- Maintains access to specialized testing, especially in rare and complex diseases.
- Reinforces the boundaries of agency authority—regulatory reform must come through Congress, not unilateral action.
As we navigate the evolving landscape of precision medicine, this case reminds us how vital regulatory clarity is—for both innovation and patient care.”
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