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组合型医疗产品的阈值分析

在本白皮书中，我们将讨论如何评估已批准和拟申请的组合产品和医疗器械之间的用户界面设计差异。

Person taking notes on a clipboard while holding a nebulizer

阈值分析指详细比较两款产品的用户界面，以识别和评估任何差异的潜在影响。在由药物评价与研究中心（CDER）于2017年1月发布的两份指导文件草案中，美国食品药品监督管理局（FDA）引入了阈值分析的概念。虽然阈值分析最初是在通用和可互换生物组合产品（即药物输送器械）的开发过程中引入的，但该方法在某些方面也适用于医疗器械开发。

Emergo by UL人因工程研究与设计团队的成员在本白皮书中介绍何时和如何进行阈值分析，以及一系列相关的注意事项。

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Threshold analyses

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hfrd-threshold-analysis-whitepaper.pdf

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了解如何进行阈值分析

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