Fed Regist. 2015 Aug 4;80(149):46192-4.
The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression device 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 external UES compression device'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）正在将外部食管上括约肌（UES）压迫装置归类为II类（特殊控制）。适用于该装置的特殊控制措施在本指令中予以明确，并且将成为外部UES压迫装置分类的法典语言的一部分。该机构将该装置归类为II类（特殊控制），以便合理确保该装置的安全性和有效性。
