Kyle Faget Assesses Status of FDA Laboratory Developed Tests Rule
Foley & Lardner LLP partner Kyle Faget commented on the status of the U.S. Food and Drug Administration’s Laboratory Developed Tests (LDT) rule in the Laboratory Economics article, “FDA Rules on LDTs is Dead…for Now.”
Faget said of a district court ruling which overturned the FDA’s final rule that “an appeal would have to be a core priority for the FDA to engage, and I don’t see that.”
“With the cutbacks on staff, there has to be prioritization within the agency,” she continued. “It’s a bandwidth problem.”
Faget also highlighted that throughout its opinion, the court “outlines its disagreement with the FDA’s expansion of its authority and interpretation of the definition of ‘device’ and the agency’s overall interpretation of its authority to regulate LDTs under the Food Drug and Cosmetic Act.”
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