Micron’s ViewPoint 第20号（医疗器械软件(SaMD)的开发- FDA指南简介-）中文版
美国食品药品监督管理局（”FDA”）于2022年9月28日发布了题为《Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k))》的最终指南（”FDA 指南”）。本文就FDA指南，重点介绍了FDA指南中被认为对CADe系统临床试验设计开发特别重要的方面。
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