# Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
> **Food and Drug Administration** · Final order. · Published 2015-11-23 · Effective 2015-11-23 · 80 FR 72899
## Document
- **Document number:** 2015-29632
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 72899
- **CFR reference:** 21 CFR 876
- **Publication date:** 2015-11-23
- **Effective date:** 2015-11-23
- **HHS docket:** Docket No. FDA-2015-N-3720
## Abstract

The Food and Drug Administration (FDA) is classifying the prostate lesion documentation 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 prostate lesion documentation system 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/2015/11/23/2015-29632/medical-devices-gastroenterology-urology-devices-classification-of-the-prostate-lesion-documentation)
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