Industry groups urge FDA to use existing controls to monitor AI-assisted devices
Regulatory NewsJoanne S. Eglovitch
Artificial intelligence/machine learning (AI/ML)CDRHDigital health/SaMD/AIMedical DevicesPerformance evaluationPharmacovigilancePostmarketing requirement/postmarketing commitmentProduct LifecycleQMSRQuality management system/QMSRegulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)