# Medical Devices; Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions
> **Food and Drug Administration** · Final amendment; final order. · Published 2023-01-20 · Effective 2023-01-20 · 88 FR 3634
## Document
- **Document number:** 2023-01048
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 88 FR 3634
- **CFR reference:** 21 CFR 876
- **Publication date:** 2023-01-20
- **Effective date:** 2023-01-20
- **HHS docket:** Docket No. FDA-2022-N-3255
## Abstract

The Food and Drug Administration (FDA, Agency, or we) is classifying the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2023/01/20/2023-01048/medical-devices-gastroenterology-urology-devices-classification-of-the-computerized-behavioral)
---
*AI Analytics · CC0 1.0*