FDA issues draft guidance on QMSR information for premarket submissions
Regulatory NewsJoanne S. Eglovitch
Approval/marketing authorizationAudit/inspectionCDRHComplianceEnforcementGuidanceMedical DevicesProduct developmentProduct LifecycleQuality Assurance and ControlQuality management system/QMSRegulatory Intelligence/PolicyRegulatory strategyUnited StatesUS Food and Drug Administration (FDA)