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Home/Standards & Frameworks/Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles

Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles

Joint FDA, Health Canada and MHRA principles on transparency for ML-enabled medical devices

Principles on who needs what information about ML-enabled medical devices, when and how (human-centred design, performance, workflow and update information), complementing the GMLP principles.

transparencymedical devicesfda

Sources

fda.govhttps://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-le…

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