Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device
fda-device · Food and Drug Administration · Rule · Published 2006-06-07 · Effective 2006-07-07 · 71 FR 32834
Document
Document number
E6-8791
Federal Register citation
71 FR 32834
CFR reference
21 CFR 874
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.