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CPC Submits Comments on FDA’s Draft LDT Framework

The CPC submitted comments on FDA’s Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Draft Guidance to recommend that FDA:

  • Couple development of the LDT Framework with
    • a “transitional” IVD approach giving more efficient access to tests developed by laboratories and traditional manufacturer
    • development of an Agency-wide guidance on companion diagnostics
  • Refrain from implementing enforcement discretion policies that restrict (1) the exchange of scientific ideas and interactions between laboratories and between laboratories and traditional manufacturers, and (2) access to the highest quality components for LDTs
  • Clarify the treatment of unmet medical need and rare disease under enforcement discretion, and the potential overlap of these categories with companion diagnostics
  • Develop, in consultation with CMS and other stakeholders, a document detailing the boundaries of the FDCA and CLIA requirements