# Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
> **Food and Drug Administration** · Final order. · Published 2017-07-28 · Effective 2017-07-28 · 82 FR 35067
## Document
- **Document number:** 2017-15894
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 35067
- **CFR reference:** 21 CFR 876
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/07/28/2017-15894/medical-devices-gastroenterology-urology-devices-classification-of-the-oral-removable-palatal-space)
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