21 CFR 874.1600 - Olfactory test device.

§ 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 § 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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 874 after this date.

  • 2016-10-24; vol. 81 # 205 - Monday, October 24, 2016
    1. 81 FR 73028 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 24, 2016. The classification was applicable on September 16, 2016.
      21 CFR Part 874