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...
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Uday Patel RAC
Regulatory Affairs Consultant
Milton GA
United States
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