Fed Regist. 2016 Oct 24;81(205):73028-30.
The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system 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 Eustachian tube balloon dilation system'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）正在将咽鼓管球囊扩张系统归类为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明确，且将成为咽鼓管球囊扩张系统分类的法典语言的一部分。该机构将该设备归类为II类（特殊控制），以便合理确保该设备的安全性和有效性。
