Guidance

Predetermined change control plans for machine learning-enabled medical devices

Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.

• 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 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.

Published 24 October 2023