Guidance

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

Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes.

From:
Medicines and Healthcare products Regulatory Agency
Published
24 October 2023

Documents

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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Details

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s 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