张慧珊,丁金聚,张译丹

FDA医用脉搏血氧仪指南构建了从研发到临床的全链条规范，以患者安全为核心，涵盖非临床测试、临床验证及标签披露，与国际标准形成互补。2025年草案强化种族差异关注，要求临床试验纳入一定比例深色皮肤人群并标注肤色影响警告，回应不同种族测量偏差问题。指南还涉及技术演进（如多光谱传感器、柔性监测）、临床验证要求、国际监管差异（与欧盟MDR对比）及未来趋势（技术融合、算法优化），文章对其进行综述分析。

FDA；医用脉搏血氧仪；指南分析

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