# Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia
> **Food and Drug Administration** · Final order. · Published 2016-02-12 · Effective 2016-02-12 · 81 FR 7452
## Document
- **Document number:** 2016-02878
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 7452
- **CFR reference:** 21 CFR 878
- **Publication date:** 2016-02-12
- **Effective date:** 2016-02-12
- **HHS docket:** Docket No. FDA-2016-N-0237
## Abstract

The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia 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 scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's 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/2016/02/12/2016-02878/medical-devices-general-and-plastic-surgery-devices-classification-of-the-scalp-cooling-system-to)
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