Proposed LDT Rule Raises Many Questions but Provides Few Answers
FDA Law
OCTOBER 6, 2023
The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. It does not extend to tests for which FDA has historically not exercised enforcement discretion (e.g.,
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