Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures
fda-device · Food and Drug Administration · Rule · Published 2016-07-13 · Effective 2016-07-13 · 81 FR 45229
Document
Document number
2016-16530
Federal Register citation
81 FR 45229
CFR reference
21 CFR 876
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-07-13
Effective date
2016-07-13
HHS docket
Docket No. FDA-2016-N-1813
Abstract
The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures 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 metallic biliary stent system for benign strictures' 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.