# Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device
> **Food and Drug Administration** · Final rule. · Published 2006-06-07 · Effective 2006-07-07 · 71 FR 32834
## Document
- **Document number:** E6-8791
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 71 FR 32834
- **CFR reference:** 21 CFR 874
- **Publication date:** 2006-06-07
- **Effective date:** 2006-07-07
- **HHS docket:** Docket No. 2006N-0182
## Abstract

The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Olfactory Test 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. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that is the special control for the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2006/06/07/E6-8791/medical-devices-ear-nose-and-throat-devices-classification-of-olfactory-test-device)
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