# Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool
> **Food and Drug Administration** · Final amendment; final order. · Published 2021-12-13 · Effective 2021-12-13 · 86 FR 70733
## Document
- **Document number:** 2021-26924
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 86 FR 70733
- **CFR reference:** 21 CFR 876
- **Publication date:** 2021-12-13
- **Effective date:** 2021-12-13
- **HHS docket:** Docket No. FDA-2021-N-0898
## Abstract

The Food and Drug Administration (FDA or we) is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I 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/2021/12/13/2021-26924/medical-devices-gastroenterology-urology-devices-classification-of-the-pressure-ulcer-management)
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