Predetermined change control plans for machine learning-enabled medical devices: Guiding principles

Overview

In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re-training risks are managed.
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re-training risks are managed.
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re-training risks are managed.
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re-training risks are managed.

External Links