Fed Regist. 2016 Feb 12;81(29):7452-4.
The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
美国食品药品监督管理局（FDA）正在将用于降低化疗引起脱发可能性的头皮冷却系统归类为II类（特殊控制）。本指令确定了适用于该设备的特殊控制措施，这些措施将成为降低化疗引起脱发可能性的头皮冷却系统编码语言的一部分。该机构将该设备归类为II类（特殊控制），以合理确保该设备的安全性和有效性。
