21 C.F.R. Subpart B—Neurological Diagnostic Devices
Title 21 - Food and Drugs
(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). (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 51730–51778, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001] (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 regulations 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 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] (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). (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). (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). (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). (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). (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). (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). (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). (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 51730–51778, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001] (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 51730–51778, Sept. 4, 1979, as amended at 66 FR 46953, Sept. 10, 2001] (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 51730–51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001] (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). (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). (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 regulations 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 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] (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 regulations 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 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 66 FR 38807, July 25, 2001] (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). (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). (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). (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). (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). (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). (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 regulations 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 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001] (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 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] (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 51730–51778, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987; 69 FR 34920, June 23, 2004] (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 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996] (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). (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). (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). (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). (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). (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). (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). (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 51730–51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001] (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).
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart B—Neurological Diagnostic Devices
§ 882.1020 Rigidity analyzer.
§ 882.1030 Ataxiagraph.
§ 882.1200 Two-point discriminator.
§ 882.1240 Echoencephalograph.
§ 882.1275 Electroconductive media.
§ 882.1310 Cortical electrode.
§ 882.1320 Cutaneous electrode.
§ 882.1330 Depth electrode.
§ 882.1340 Nasopharyngeal electrode.
§ 882.1350 Needle electrode.
§ 882.1400 Electroencephalograph.
§ 882.1410 Electroencephalograph electrode/lead tester.
§ 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
§ 882.1430 Electroencephalograph test signal generator.
§ 882.1460 Nystagmograph.
§ 882.1480 Neurological endoscope.
§ 882.1500 Esthesiometer.
§ 882.1525 Tuning fork.
§ 882.1540 Galvanic skin response measurement device.
§ 882.1550 Nerve conduction velocity measurement device.
§ 882.1560 Skin potential measurement device.
§ 882.1570 Powered direct-contact temperature measurement device.
§ 882.1610 Alpha monitor.
§ 882.1620 Intracranial pressure monitoring device.
§ 882.1700 Percussor.
§ 882.1750 Pinwheel.
§ 882.1790 Ocular plethysmograph.
§ 882.1825 Rheoencephalograph.
§ 882.1835 Physiological signal amplifier.
§ 882.1845 Physiological signal conditioner.
§ 882.1855 Electroencephalogram (EEG) telemetry system.
§ 882.1870 Evoked response electrical stimulator.
§ 882.1880 Evoked response mechanical stimulator.
§ 882.1890 Evoked response photic stimulator.
§ 882.1900 Evoked response auditory stimulator.
§ 882.1925 Ultrasonic scanner calibration test block.
§ 882.1950 Tremor transducer.
