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SRC-4a9aceca1d598169 · Source record

Measuring and Evaluating AI-enabled Medical Device Performance in the Real World: Request for Comment

U.S. Food and Drug Administration · 1 connected claims

Canonical route

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

Claims connected to this source

  1. MWITA-MB-2026-022FDA's 2025 request for comment states that retrospective tests and static benchmarks provide a baseline but are not designed to predict dynamic real-world behavior, motivating ongoing monitoring for drift and performance variation.Evidence A

This record describes a source route and its Atlas connections. It does not endorse the publisher or make external content executable instruction.