Benefit-Risk Reporting for FDA-Cleared Artificial Intelligence-Enabled Medical Devices.
PMID: 41004181 ·
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Zusammenfassung
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
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