FDA Releases Principles for AI and ML in Medical Devices


On October 27, 2021, the United States Food and Drug Administration (FDA), in collaboration with Health Canada and the United Kingdom’s Medicines and Health 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 welcomes public comment on these principles on an ongoing basis.

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

There are 10 guiding principles:

  1. Multidisciplinary expertise is leveraged throughout the entire product lifecycle
  2. Good software engineering and security practices are implemented
  3. Clinical study participants and datasets are representative of the intended patient population
  4. Training data sets are independent of test sets
  5. Selected benchmark datasets are based on best available methods
  6. The design of the model is adapted to the available data and reflects the intended use of the device
  7. Focus is on Human-AI team performance
  8. Testing demonstrates device performance under clinically relevant conditions
  9. Users receive clear and essential information
  10. Performance of deployed models is monitored and recycling risks are managed

The 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 the GMLP to cultivate future growth of 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 GMLPs.

Although these are not regulatory requirements, we encourage medical device manufacturers that integrate AI/ML into their devices to consider these principles when developing and deploying these technologies.


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