# Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use
> **Food and Drug Administration** · Final order. · Published 2017-03-14 · Effective 2017-03-14 · 82 FR 13551
## Document
- **Document number:** 2017-04941
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 13551
- **CFR reference:** 21 CFR 862
- **Publication date:** 2017-03-14
- **Effective date:** 2017-03-14
- **HHS docket:** Docket No. FDA-2017-N-1142
## Abstract

The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use 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 classification of the high throughput genomic sequence analyzer for clinical use device. 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/2017/03/14/2017-04941/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-high)
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