# Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems
> **Food and Drug Administration** · Final order. · Published 2017-12-27 · Effective 2017-12-27 · 82 FR 61162
## Document
- **Document number:** 2017-27853
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 61162
- **CFR reference:** 21 CFR 862
- **Publication date:** 2017-12-27
- **Effective date:** 2017-12-27
- **HHS docket:** Docket No. FDA-2017-N-6593
## Abstract

The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) 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, in part by reducing regulatory burdens.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/12/27/2017-27853/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-reagents)
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