Guidance: Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

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Medicines Healthcare Products Regulatory Agency

October 24

15:02 2023

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Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

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Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 5 guiding principles for the use of Predetermined Change Control Plans (PCCPs). PCCPs provide a new method for managing rapid product changes often seen with Software and Artificial Intelligence products. These guiding principles will help to ensure alignment between our jurisdictions on PCCPs and products utilising them.

Published 24 October 2023

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