Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
fda-device · Food and Drug Administration · Rule · Published 2017-07-28 · Effective 2017-07-28 · 82 FR 35067
Document
Document number
2017-15894
Federal Register citation
82 FR 35067
CFR reference
21 CFR 876
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-07-28
Effective date
2017-07-28
HHS docket
Docket No. FDA-2017-N-1609
Abstract
The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss 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 oral removable palatal space occupying device for weight management and/or weight loss 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.