 
The growing adoption of new software tools and digital platforms, that incorporate machine learning to meet patient needs, highlights the importance of promoting an internationally harmonized approach to Predetermined Change Control Plans (PCCPs) for Artificial Intelligence and Machine Learning (AI/ML)-enabled devices.
Today, the U. S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles. The 5 guiding principles outline key characteristics of robust Predetermine Change Control Plans (PCCPs). PCCPs are one way to support the development of safe, effective, and high-quality devices enabled with AI/ML technologies.
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This joint publication is a continuation of our international collaboration on Good Machine Learning Practice Guiding Principles. Together, these collaborations build on efforts outlined in the FDA’s Artificial Intelligence and Machine Learning Action Plan, and highlight the FDA’s commitment to support predictability and principles harmonizing regulatory considerations across jurisdictions. For more information, please read the CDRH Statement.
Questions?
If you have questions about the PCCP Guiding Principles, please contact the Digital Health Center of Excellence, email digitalhealth@fda.hhs.gov.
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