FDA releases joint AI medical device guidance with Canada, U.K.


The U.S. Food and Drug Administration and its counterparts in Canada and the United Kingdom issued joint guidelines for companies creating medical devices that use artificial intelligence on Wednesday.

The 10 “guiding principles” from the FDA, Health Canada and the U.K. Medicines and Healthcare Products Regulatory Agency applying expertise from multiple disciplines throughout product development and testing AI devices on data that’s representative of the intended patient population.

The trilateral regulatory framework seeks to establish a foundation for safe and effective use of AI and machine learning in medical devices that organizations such as the International Medical Device Regulators Forum can build upon.

The three governments expect their action to promote international collaboration on research, educational resources and standards.

“As the [artificial intelligence/machine learning] medical device field evolves, so too must [Good Machine Learning Practice] best practice and consensus standards,” the guidance says. “Strong partnerships with our international public health partners will be crucial if we are to empower stakeholders to advance responsible innovations in this area.”

The guidelines build on previous FDA initiatives to modernize and clarify how it governs AI medical devices. The FDA released its first action plan on regulating artificial intelligence this year, which emphasizes that AI can be more challenging to regulate than other types of medical devices since artificial intelligence continuously adapts in response to new data.

The agency hosted a virtual workshop on how to make the ways AI functions in medical devices more transparent this month, prompted in part by emerging evidence that racial biases are built into AI tools.

The FDA’s Digital Health Center of Excellence is seeking feedback on the new joint guidelines. The FDA established the office last year to centralize the its digital health activities, which include efforts to update how it regulates medical devices that incorporate AI, mobile apps and wearable technologies.



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