Medical Devices; Gastroenterology-Urology Devices; Classification of the Colon Capsule Imaging System
fda-device · Food and Drug Administration · Rule · Published 2014-05-16 · Effective 2014-06-16 · 79 FR 28401
Document
Document number
2014-11173
Federal Register citation
79 FR 28401
CFR reference
21 CFR 876
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-05-16
Effective date
2014-06-16
HHS docket
Docket No. FDA-2014-N-0431
Abstract
The Food and Drug Administration (FDA) is classifying the colon capsule imaging 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 colon capsule imaging 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.