Guiding principles: Predetermined change control plans for machine learning-enabled medical devices
Information
Type
Miscellaneous
Regulated products
Medical Devices
Published
July 29, 2024
Last updated
July 29, 2024
Description
FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans, drawing upon GMLP guiding principles, particularly stating that deployed models are monitored for performance and re-training risks are managed.
Tags
Organization
Country / Region
Canada
License
Open Government License 2.0 (Canada)