Proposed LDT Rule Raises Many Questions but Provides Few Answers
FDA Law
OCTOBER 6, 2023
The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.) 150,000).”
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