(a) Identification. An olfactory test device is used to determine whether an olfactory loss is present. The device includes one or more odorants that are presented to the patient's nose to subjectively assess the patient's ability to perceive odors.

(b) Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Olfactory Test Device.” For the availability of this guidance document, see §874.1(e). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9. When indicated for the screening or diagnosis of diseases or conditions other than the loss of olfactory function, the device is not exempt from premarket notification procedures.

[71 FR 32835, June 7, 2006]