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. How to leverage “programs such as the New York State Department of Health Clinical Laboratory Evaluation Program (NYSDOH CLEP) or those within the Veterans Health Administration (VHA).”
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