FDA Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan

Summary

FDA's Center for Devices and Radiological Health published a five-part action plan in January 2021, responding to feedback on its 2019 discussion paper on modifications to AI/ML-based software as a medical device. It is a work plan, not a rule or guidance. Later FDA outputs on the same themes, now listed on FDA's AI-enabled medical devices page, include the Good Machine Learning Practice guiding principles (October 2021, with Health Canada and the UK MHRA), guiding principles on PCCPs and on transparency for ML-enabled devices, the final PCCP guidance for AI-enabled device software functions (December 2024, revised August 2025) and the draft lifecycle guidance (January 2025). FDA reports more than 1,600 AI-enabled devices authorized as of September 2026.

Key dates

1. January 2021Takes effect
2. January 2021Issued
3. October 16, 2026Checked against sources
4. October 21, 2026Checked against sources

Developments are added when the record is reviewed. Next review: October 16, 2027.

Evidence

Each passage is quoted from its source. The quoted passages are re-checked against the live pages every month.

1. Additional Resources Artificial Intelligence Program: Research on AI/ML-Based Medical Devices Artificial Intelligence and Machine Learning Software as a Medical Device Action Plan

   Supports: Plan still listed; URL redirects to /artificial-intelligence-enabled-medical-devices

   The FDA has authorized over 1,600 AI-enabled medical devices for marketing in the United States as of September 2026.

   Supports: Current context

   Guiding Principles Good Machine Learning Practice for Medical Device Development Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices Transparency for Machine Learning-Enabled Medical Devices

   Supports: Related guiding principles

   Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration Primary source

2. Software as a Medical Device (SaMD) Action Plan January 2021

   Supports: Title and date

   we will briefly describe a five-part Action Plan to advance this work.

   Supports: Five-part plan

   AI/ML-Based SaMD Action Plan U.S. Food and Drug Administration, CDRH Primary source

3. The final document from IMDRF builds on the guiding principles released in October 2021 by the U.S. Food and Drug Administration, Health Canada, and the United Kingdom's Medicines and Healthcare products Regulatory Agency.

   Supports: GMLP date

   Good Machine Learning Practice for Medical Device Development: Guiding Principles U.S. Food and Drug Administration Primary source