[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.1600]

[Page 366]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874_EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart B_Diagnostic Devices
 
Sec. 874.1600  Olfactory test device.

    (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 Sec. 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 Sec. 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]