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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR882]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 882NEUROLOGICAL DEVICES
 

Subpart B--Neurological Diagnostic Devices

Sec. 882.1020 Rigidity analyzer.

(a)Identification. A rigidity analyzer is a device for quantifying the extent of the rigidity of a patient's limb to determine the effectiveness of drugs or other treatments.

(b)Classification. Class II (performance standards).

Sec. 882.1030 Ataxiagraph.

(a)Identification. An ataxiagraph is a device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed.

(b)Classification. Class I (general controls).

[44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001]

Sec. 882.1200 Two-point discriminator.

(a)Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

Sec. 882.1240 Echoencephalograph.

(a)Identification. An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.

(b)Classification. Class II (performance standards).

Sec. 882.1275 Electroconductive media.

(a)Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

(b)Classification. Class II (performance standards).

Sec. 882.1310 Cortical electrode.

(a)Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.

(b)Classification. Class II (performance standards).

Sec. 882.1320 Cutaneous electrode.

(a)Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

(b)Classification. Class II (performance standards).

Sec. 882.1330 Depth electrode.

(a)Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

(b)Classification. Class II (performance standards).

Sec. 882.1340 Nasopharyngeal electrode.

(a)Identification. A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.

(b)Classification. Class II (performance standards).

Sec. 882.1350 Needle electrode.

(a)Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

(b)Classification. Class II (performance standards).

Sec. 882.1400 Electroencephalograph.

(a)Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

(b)Classification. Class II (performance standards).

Sec. 882.1410 Electroencephalograph electrode/lead tester.

(a)Identification. An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001]

Sec. 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.

(a)Identification. An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.

(b)Classification. Class I (general controls).

[44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46953, Sept. 10, 2001]

Sec. 882.1430 Electroencephalograph test signal generator.

(a)Identification. An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

Sec. 882.1460 Nystagmograph.

(a)Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

(b)Classification. Class II (performance standards).

Sec. 882.1480 Neurological endoscope.

(a)Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

(b)Classification. Class II (performance standards).

Sec. 882.1500 Esthesiometer.

(a)Identification. An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

Sec. 882.1525 Tuning fork.

(a)Identification. A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 66 FR 38807, July 25, 2001]

Sec. 882.1540 Galvanic skin response measurement device.

(a)Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.

(b)Classification. Class II (performance standards).

Sec. 882.1550 Nerve conduction velocity measurement device.

(a)Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

(b)Classification. Class II (performance standards).

Sec. 882.1560 Skin potential measurement device.

(a)Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

(b)Classification. Class II (performance standards).

Sec. 882.1570 Powered direct-contact temperature measurement device.

(a)Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.

(b)Classification. Class II (performance standards).

Sec. 882.1610 Alpha monitor.

(a)Identification. An alpha monitor is a device with electrodes that are placed on a patient's scalp to monitor that portion of the electroencephalogram which is referred to as the alpha wave.

(b)Classification. Class II (performance standards).

Sec. 882.1620 Intracranial pressure monitoring device.

(a)Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

(b)Classification. Class II (performance standards).

Sec. 882.1700 Percussor.

(a)Identification. A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

Sec. 882.1750 Pinwheel.

(a)Identification. A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

Sec. 882.1790 Ocular plethysmograph.

(a)Identification. An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).

(b)Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any ocular plethysmograph that was in commercial distribution before May 28, 1976. Any other ocular plethysmograph shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987; 69 FR 34920, June 23, 2004]

Sec. 882.1825 Rheoencephalograph.

(a)Identification. A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area.

(b)Classification. Class III (premarket approval).

(c)Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any rheoencephalograph that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a rheoencephalograph that was in commercial distribution before May 28, 1976. Any other rheoencephalograph shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996]

Sec. 882.1835 Physiological signal amplifier.

(a)Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

(b)Classification. Class II (performance standards).

Sec. 882.1845 Physiological signal conditioner.

(a)Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

(b)Classification. Class II (performance standards).

Sec. 882.1855 Electroencephalogram (EEG) telemetry system.

(a)Identification. An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.

(b)Classification. Class II (performance standards).

Sec. 882.1870 Evoked response electrical stimulator.

(a)Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

(b)Classification. Class II (performance standards).

Sec. 882.1880 Evoked response mechanical stimulator.

(a)Identification. An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.

(b)Classification. Class II (performance standards).

Sec. 882.1890 Evoked response photic stimulator.

(a)Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

(b)Classification. Class II (performance standards).

Sec. 882.1900 Evoked response auditory stimulator.

(a)Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

(b)Classification. Class II (performance standards).

Sec. 882.1925 Ultrasonic scanner calibration test block.

(a)Identification. An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

Sec. 882.1935 Near Infrared (NIR) Brain Hematoma Detector.

(a)Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.

(b)Classification. Class II (special controls). The special controls for this device are:

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 801.109 of this chapter;

(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;

(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;

(4) Performance data should validate accuracy and precision and safety features;

(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,

(6) Appropriate software verification, validation, and hazard analysis should be performed.

[77 FR 16927, Mar. 23, 2012]

Sec. 882.1950 Tremor transducer.

(a)Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.

(b)Classification. Class II (performance standards).

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

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