The Regulatory Landscape of Laboratory Developed Tests (LDT): A Laboratorian Perspective
The FDA released a proposed LDT rule and stated it will \u201cend its enforcement discretion\u201d of LDTs. Previously, the FDA explored other avenues for regulating LDTs. We will discuss questions relevant to the draft rule and implications to laboratory medicine, including, but not limited to:\n- What are possible implications of FDA regulation of LDTs?\n- Is the FDA the appropriate mechanism for this LDT oversight?\n- What about modernization of CLIA?\n- What would be the financial cost?\n- What would be the diagnostic cost?