Glossary · Regulation
AI-enabled Medical Device
AI/ML-based medical device
AI-enabled Medical Device
RegulatoryA medical device whose function depends wholly or partly on a machine-learning model.
Adds obligations that static software does not carry: data governance, change control and monitoring of performance after release.
Context
Broader termSoftware as a Medical Device
RelatedSoftware as a Medical Device, Predetermined Change Control Plan, Post-Market Surveillance, Model Drift
SourceFDA, Artificial Intelligence-Enabled Device Software Functions guidance