Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices
- Registration Date 2023-07-20
- Hit 2705
This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyze medical data to diagnose, control, or predict diseases.
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Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices.pdf Download
Division Digital Health Device Division
Written by Chungkeun Lee
Telephone +82-43-719-3946