Medical devices; ear, nose, and throat devices; classification of olfactory test device. Final rule.
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.
D019719:Diagnostic Equipment / Q000145:classification*; D004869:Equipment Safety; D006801:Humans; D000857:Olfaction Disorders / Q000175:diagnosis; D010036:Otolaryngology / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration