Experts: Strong design controls are key to FDA device approval
Regulatory NewsJoanne S. Eglovitch
510(k)Approval/marketing authorizationCDRHClinical TrialsComplianceDiagnostics/IVDsMedical DevicesPreclinical studyProduct developmentRegulatory Intelligence/PolicyRegulatory strategyTechnical documentationUnited StatesUS Food and Drug Administration (FDA)