FDA Action Plan for AI/ML-Based Software as a Medical Device

The FDA regulates AI and machine learning software that meets the definition of a medical device (Software as a Medical Device, or SaMD). The FDA's AI/ML action plan and associated guidance documents establish requirements for pre-market review, post-market monitoring, and predetermined change control plans — a framework that allows AI models to learn and adapt within predefined boundaries without requiring a new 510(k) each time.

Key requirements

• AI/ML SaMD may require 510(k) clearance or De Novo authorization before US marketing
• Predetermined Change Control Plan (PCCP) allows AI updates within pre-approved bounds
• Algorithm change protocols must be documented and submitted to FDA before implementation
• Post-market surveillance required to detect real-world performance degradation
• Good Machine Learning Practice (GMLP) principles apply to development and validation

Key terms

Further reading

• How to Do an AI Risk Assessment (Small Team Guide)
• AI Vendor Due Diligence in 30 Minutes (Questions + Scoring Sheet)