On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices.   The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.

FDA notes that AI/ML technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. They use software algorithms to learn from real-world use and in some situations, may use this information to improve the product’s performance. However, they also present unique considerations due to their complexity and the iterative and data-driven nature of their development.

There are 10 guiding principles:

  1. Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle
  2. Good Software Engineering and Security Practices Are Implemented
  3. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population
  4. Training Data Sets Are Independent of Test Sets
  5. Selected Reference Datasets Are Based Upon Best Available Methods
  6. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device
  7. Focus Is Placed on the Performance of the Human-AI Team
  8. Testing Demonstrates Device Performance During Clinically Relevant Conditions
  9. Users Are Provided Clear, Essential Information
  10. Deployed Models Are Monitored for Performance and Re-training Risks Are Managed

FDA notes that these guiding principles address the unique nature of medical device products that incorporate AI/ML and are intended to lay the foundation for GMLP to cultivate future growth in medical devices using AI/ML.  The agency also notes that there are areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations, and other collaborative bodies could work to advance GMLP.

While these are not regulatory requirements, we encourage medical device manufacturers that incorporate AI/ML in their devices to consider these principles in the development and deployment of such technology.