Fed Regist. 2017 Oct 24;82(204):49098-100.
The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
美国食品药品监督管理局（FDA 或我们）正在将用于检测和测量人体临床标本中非微生物分析物以辅助评估疑似脓毒症患者的设备分类为 II 类（特殊控制）。适用于该设备类型的特殊控制措施在本指令中予以明确，并且将成为用于检测和测量人体临床标本中以辅助评估疑似脓毒症患者的非微生物分析物的设备编码语言的一部分。我们采取这一行动是因为我们已经确定，将该设备分类为 II 类（特殊控制）将为该设备的安全性和有效性提供合理保证。我们相信这一行动还将部分通过减轻监管负担来增加患者获得有益创新设备的机会。
