Proposed LDT Rule Raises Many Questions but Provides Few Answers
FDA Law Blog
OCTOBER 6, 2023
The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. However, meeting this timeline would require FDA to issue a final rule within approximately six months of the PR’s publication date—in other words, by April 2024. The fate of the PR is far from certain.
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