United States Food and Drug Administration ↔ machine learning

Relations (1)

cross_type 2.00 — strongly supporting 3 facts

The United States Food and Drug Administration regulates machine learning by introducing new change control approaches for AI/ML-enabled medical devices [1] and publishing Good Machine Learning Practice (GMLP) guidance [2], while specifically adapting its oversight to address the unique challenges of supervised learning systems [3].

Facts (3)

Sources

Medical Hallucination in Foundation Models and Their ... medrxiv.org medRxiv 3 facts

claimThe U.S. Food and Drug Administration (FDA) has introduced new approaches to change control for AI/ML-enabled medical devices to allow for more flexible oversight of systems that continue to learn and evolve after deployment.

referenceThe FDA published Good Machine Learning Practice (GMLP) guidance to address challenges in AI/ML-enabled medical devices, specifically covering data quality, algorithm validation, and performance monitoring.

claimFDA adaptations for AI/ML-enabled medical devices primarily address supervised learning systems rather than the unique challenges posed by generative AI.