Proposed LDT Rule Raises Many Questions but Provides Few Answers
FDA Law
OCTOBER 6, 2023
There is much to unpack, and we intend to do so in a series of blog posts. The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” . Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation.
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