Analysis of devices authorized by the FDA for clinical decision support in critical care

The use of predictive clinical decision support (CDS) devices (ie, those that use machine learning [ML] or artificial intelligence [AI]) has the potential to improve outcomes in critical care, but a clear regulatory framework is lacking. Recent guidance from the US Food and Drug Administration (FDA) suggests most CDS tools for critical illness will be regulated because of the time-sensitive nature of the decisions informed by these devices. However, growing concerns about the clinical impact of predictive CDS systems raise questions about whether current device regulatory frameworks, developed before advanced statistical learning methods were widely available, are sufficient to ensure effectiveness and safety.

Jessica T Lee, Alexander T Moffett, George Maliha, Zahra Faraji, Genevieve P Kanter, Gary E Weissman