# Predetermined change control plans for machine learning-enabled medical devices

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a5f4e1e1-389d-4847-a1cf-faecaff275b7
Type: Guidance
Published: October 23, 2023

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

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## Content

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.

## Attachments

- [Predetermined change control plans for machine learning-enabled medical devices: guiding principles](/government/publications/predetermined-change-control-plans-for-machine-learning-enabled-medical-devices-guiding-principles/predetermined-change-control-plans-for-machine-learning-enabled-medical-devices-guiding-principles)
- [Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles](https://assets.publishing.service.gov.uk/media/6537be725e47a500149898dc/Predetermined_Change_Control_Plans_-_Guiding_Principles.pdf)