Benefit-Risk Reporting for FDA-Cleared Artificial Intelligence-Enabled Medical Devices.

Abstract

Devices enabled by artificial intelligence (AI) and machine learning (ML) are increasingly used in clinical settings, but there are concerns regarding benefit-risk assessment and surveillance by the US Food and Drug Administration (FDA). To characterize pre- and postmarket efficacy, safety, and risk assessment reporting for FDA-cleared AI/ML devices. This was a cross-sectional study using linked data from FDA decision summaries and approvals databases, the FDA Manufacturer and User Facility Devi