Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device
Information
Type
Rule
Regulated products
Medical Devices
Published
June 7, 2006
Last updated
June 7, 2006
Description
Document number E6-8791. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)