Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
fda-device · Food and Drug Administration · Rule · Published 2016-10-24 · Effective 2016-10-24 · 81 FR 73028
Document
Document number
2016-25602
Federal Register citation
81 FR 73028
CFR reference
21 CFR 874
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-10-24
Effective date
2016-10-24
HHS docket
Docket No. FDA-2016-N-3287
Abstract
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.