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CDRH reclassification of IVDs from 31Jan2024 update
Posted By
Uday Patel
02-Feb-2024 13:22
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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). ...
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