Medical Devices; Gastroenterology-Urology Devices; Classification of the Rectal Control System
fda-device · Food and Drug Administration · Rule · Published 2015-06-01 · Effective 2015-06-01 · 80 FR 30931
Document
Document number
2015-13067
Federal Register citation
80 FR 30931
CFR reference
21 CFR 876
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-06-01
Effective date
2015-06-01
HHS docket
Docket No. FDA-2015-N-1338
Abstract
The Food and Drug Administration (FDA) is classifying the rectal control 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 rectal control 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.