Introduction to FDA Guidance on the Development of SaMD (Chinese version)

The U.S. Food and Drug Administration (FDA) announced the final revised guidance titled “Clinical Performance Assessment: Considerations for Computer Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k))”(referred to as the “FDA Guidance” below) in September 2022. This issue offers insights in Chinese on key aspects of the FDA Guidance that are particularly important for formulating the clinical trial design of Computer Assisted Detection (CADe) systems.

Micron’s ViewPoint Introduction to FDA Guidance on the Development of SaMD(Chinese version)