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CDRH reclassification of IVDs from 31Jan2024 update

  • 1.  CDRH reclassification of IVDs from 31Jan2024 update

    Posted 02-Feb-2024 13:22

    With CDRHs initiative to reclassify high risk class III IVDs to Class II, interested to hear feedback on impact of this initiative in the context of gene therapy trials where companion diagnostics (CDx) have required concurrent approvals with your BLAs and via PMA route (in majority of gene therapy trials).  E.g. Transduction Inhibition Assay has been used to evaluate levels of inhibitory antibodies prior to treatment with gene therapy.  Strategy we are considering is CDx approval pathway as a single site IVD and PMA filing versus commercialization as laboratory developed test (class II?); comments appreciated...

    Uday Patel RAC
    Regulatory Affairs Consultant
    Milton GA
    United States