FDA Guidance on Artificial Intelligence and Machine Learning in Software as a Medical Device
The FDA's approach to AI/ML-enabled medical devices, covering predetermined change-control plans, good machine-learning practice and transparency to clinicians. The main route to market for clinical AI in the US.
Key dates
- Jan 12, 2021AI/ML SaMD Action Plan published
- Jan 7, 2025Draft guidance on AI-enabled device software functions issued
Risk areas addressed
Who it applies to
Manufacturers of AI- or ML-enabled software functions marketed as medical devices in the United States.
Penalties & enforcement
Device marketing restrictions, recalls and enforcement under the FD&C Act.
Enforced by: US Food and Drug Administration (CDRH)
FDA AI/ML SaMD Guidance is enforced by US Food and Drug Administration (CDRH). Its obligations are already live, so a gap is a present exposure rather than a future one. In practice that means knowing which of your AI systems fall in scope in healthcare and medical devices, holding assessments that speak to safety & robustness, transparency and bias & discrimination, and being able to produce that evidence on request, including for systems built outside the jurisdiction.