FDA issues draft guidance on QMSR information for premarket submissions

FDA issues draft guidance on QMSR information for premarket submissions | RAPSRegulatory NewsJoanne S. EglovitchApproval/marketing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