Future of LDT Oversight Unclear Following Court's Rejection of FDA Rule
Of Counsel Benjamin Zegarelli was quoted in 360Dx related to the future of oversight for laboratory-developed-test following a recent decision in the Eastern District of Texas that vacated the FDA's final rule on LDTs.
Benjamin suggested that, while the decision clearly states the FDA lacks legal authority over LDTs, it could also raise broader concerns about the agency’s jurisdiction over other products. This uncertainty, he suggested, may lead an appeal by the FDA, despite previous opposition to LDT regulation from the Trump administration.
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