MHRA, FDA and Health Canada offer “guiding principles” for predetermined change control plans

Regulators from the U.S., the U.K., and Canada previously released guiding principles for good machine learning practices. Now, the trio have just published a new series of “guiding principles” for pre-determined change control plans (PCCPs) for machine learning-enabled medical devices. The regulators suggest that PCCPs need to be transparent, risk-based, bounded and operate throughout the product life cycle.

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