Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Upper Esophageal Sphincter Compression Device
fda-device · Food and Drug Administration · Rule · Published 2015-08-04 · Effective 2015-08-04 · 80 FR 46192
Document
Document number
2015-19074
Federal Register citation
80 FR 46192
CFR reference
21 CFR 874
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-08-04
Effective date
2015-08-04
HHS docket
Docket No. FDA-2015-N-2525
Abstract
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.