CDRH officials say pre-submission meetings can improve odds for de novo requests
Regulatory NewsFerdous Al-Faruque
De novoDiagnostics/IVDsGuidanceMedical DevicesRegulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)Regulatory NewsFerdous Al-FaruqueDe novoDiagnostics/IVDsGuidanceMedical DevicesRegulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)