# Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System
> **Food and Drug Administration** · Final order. · Published 2015-10-27 · Effective 2015-10-27 · 80 FR 65626
## Document
- **Document number:** 2015-27197
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 65626
- **CFR reference:** 21 CFR 866
- **Publication date:** 2015-10-27
- **Effective date:** 2015-10-27
- **HHS docket:** Docket No. FDA-2015-N-3472
## Abstract

The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified 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/2015/10/27/2015-27197/medical-devices-immunology-and-microbiology-devices-classification-of-autosomal-recessive-carrier)
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