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Evidence Explorer · EV-009

AI real-world performance

FDA identifies post-deployment AI performance, drift, clinical outcomes, infrastructure, and human-AI interaction as important real-world evaluation concerns.

E596/100 confidenceFederal policy/science discussion

What this evidence supports

FDA's digital-health work emphasizes lifecycle monitoring for AI-enabled medical-device performance in real-world use.

What it does not establish

The referenced request for comment is not final guidance and does not itself establish enforceable requirements.

Record details

Source authority: FDA
Evidence level: E5
Directness: 5/5
Recency: 4/5
Decision relevance: 5/5
Date: 2026-08-08

Primary source

https://www.fda.gov/medical-devices/digital-health-center-excellence/request-public-comment-measuring-and-evaluating-artificial-intelligence-enabled-medical-device

Related intelligence

FDA keeps real-world performance monitoring of AI-enabled medical devices as a major digital-health policy topic