Fed Regist. 2016 Dec 6;81(234):87810-2.
The Food and Drug Administration (FDA) is classifying the Computerized Cognitive Assessment Aid for Concussion 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 computerized cognitive assessment aid for concussion'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）正在将用于脑震荡的计算机化认知评估辅助设备归类为II类（特殊控制）。适用于该设备的特殊控制措施在本指令中予以确定，并且将成为用于脑震荡的计算机化认知评估辅助设备分类的编码语言的一部分。该机构将该设备归类为II类（特殊控制），以便合理保证该设备的安全性和有效性。
