A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?
FDA Law Blog
NOVEMBER 1, 2023
Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). The PR states that LDTs are not the “practice of medicine,” with which FDA generally may not interfere.
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