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.
Document
Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device
The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression device into class II (special controls). The special controls tha...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
80 FR 46192
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device,” thefederalregister.org (August 4, 2015), https://thefederalregister.org/documents/2015-19074/medical-devices-ear-nose-and-throat-devices-classification-of-the-external-upper-esophageal-sphincter-compression-device.