Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices
- Registration Date 2023-07-20
- Hit 2845
This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS) and computer-aided detection/diagnosis (CAD) software fall under this category.
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Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices.pdf Download
Division Digital Health Device Division
Written by Chungkeun Lee
Telephone +82-43-719-3982