21 C.F.R. PART 882—NEUROLOGICAL DEVICES
Title 21 - Food and Drugs
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.
(a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by §807.87. (c) To avoid duplicative listings, a neurological device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.php. [52 FR 17739, May 11, 1987, as amended at 68 FR 70436, Dec. 18, 2003] A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section, 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. [52 FR 17739, May 11, 1987] The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in §812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2319, Jan. 14, 2000] (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). (a) Identification. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull. (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 38808, July 25, 2001] (a) Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle. (b) Classification. Class I (general controls). When made only of surgical grade stainless steel, 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 65 FR 2319, Jan. 14, 2000] (a) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance standards). (a) Identification. A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp. (b) Classification. Class II (performance standards). (a) Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips. (b) Classification. Class II (performance standards). (a) Identification. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [44 FR 51730–51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] (a) Identification. A clip removal instrument is a device used to remove surgical clips from the patient. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A clip rack is a device used to hold or store surgical clips during surgery. (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 54 FR 25051, June 12, 1989; 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site. (b) Classification. Class II (performance standards). (a) Identification. A dowel cutting instrument is a device used to cut dowels of bone for bone grafting. (b) Classification. Class II (performance standards). (a) Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull. (b) Classification. Class II (performance standards). (a) Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain. (b) Classification. Class II (performance standards). (a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull. (b) Classification. Class II (performance standards). (a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull. (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 38808, July 25, 2001] (a) Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull. (b) Classification. Class II (performance standards). (a) Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull. (b) Classification. Class II (performance standards). (a) Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites. (b) Classification. Class II (performance standards). (a) Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures. (b) Classification. Class II (performance standards). (a) Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin. (b) Classification. Class I (general controls). When made only of surgical grade stainless steel, 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 65 FR 2319, Jan. 14, 2000] (a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. (b) Classification. Class II (performance standards). (a) Identification. A leukotome is a device used to cut sections out of the brain. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue. (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, 198965 FR 2319, Jan. 14, 2000] (a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding. (b) Classification. Class II (performance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004] (a) Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired. (b) Classification. Class II (performance standards). (a) Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means. (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. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under §882.4305. [44 FR 51730–51778, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] (a) Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery. (b) Classification. Class II (performance standards). (a) Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column. (b) Classification. Class II (performance standards). (a) Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column. (b) Classification. Class II (performance standards). (a) Identification. A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws. (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 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip. (b) Classification. Class II (performance standards). (a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to §882.9. [44 FR 51730–51778, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998] (a) Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions. (b) Classification. Class II (performance standards). (a) Identification. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels. (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 intravascular occluding catheter 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 an intravascular occluding catheter that was in commercial distribution before May 28, 1976. Any other intravascular occluding catheter 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 carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. The clamp is used to occlude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flow to the aneurysm or malformation. (b) Classification. Class II (performance standards). (a) Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting. (b) Classification. Class II (performance standards). (a) Identification. An implanted malleable clip is a bent wire or staple that is forcibly closed with a special instrument to occlude an intracranial blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissue or a mechanical device in place in a patient. (b) Classification. Class II (performance standards). (a) Identification. An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics. (b) Classification. Class II (performance standards). (a) Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. (b) Classification. Class II (performance standards). (a) Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors). (b) Classification. Class II (performance standards). (a) Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect. (b) Classification. Class II (performance standards). (a) Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material. (b) Classification. Class II (performance standards). (a) Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material. (b) Classification. Class II (performance standards). (a) Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect. (b) Classification. Class II (performance standards). (a) Identification. A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe. (b) Classification. Class II (performance standards). (a) Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt. (b) Classification. Class II (performance standards). (a) Identification. A cranial electrotheraphy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety. (b) Classification. Class III (premarket approval). (c) Date a PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §882.3. [44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 60 FR 43969, Aug. 24, 1995; 62 FR 30457, June 4, 1997] (a) Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait. (b) Classification. Class II (performance standards). (a) Identification. An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's cerebellum and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (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 26, 1984. Any implanted cerebellar stimulator that was not in commercial distribution before May 28, 1976, or that has not on or before September 26, 1984 been found by FDA to be substantially equivalent to an implanted cerebellar stimulator that was in commercial distribution before May 28, 1976 shall have an approved PMA or declared completed PDP in effect before beginning commercial distribution. [44 FR 51730–51778, Sept. 4, 1979 and 49 FR 26574, June 28, 1984] (a) Identification. An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (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 July 7, 1986 for any implanted diaphragmatic/phrenic nerve stimulator that was in commercial distribution before May 28, 1976, or that has on or before July 7, 1986 been found to be substantially equivalent to an implanted diaphragmatic/phrenic nerve stimulator that was in commercial distribution before May 28, 1976. Any other implanted diaphragmatic/phrenic nerve stimulator 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 51 FR 12101, Apr. 8, 1986] (a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (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 March 1, 1989, for any implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976, or that has on or before March 1, 1989, been found to be substantially equivalent to an implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976. Any other implanted intracerebral/subcortical stimulator for pain relief 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 53 FR 48621, Dec. 1, 1988] (a) Identification. An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (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 implanted spinal cord stimulator for bladder evacuation 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 an implanted spinal cord stimulator for bladder evacuation that was in commercial distribution before May 28, 1976. Any other implanted spinal cord stimulator for bladder evacuation 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. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient's shoe. (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 for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any implanted neuromuscular stimulator that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an implanted neuromuscular stimulator that was in commercial distribution before May 28, 1976. Any other implanted neuromuscular stimulator 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 17740, May 11, 1987; 64 FR 18329, Apr. 14, 1999] (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an inplanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class II (performance standards). (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class II (performance standards). (a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. (b) Classification. Class II (performance standards). (a) Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together. (b) Classification. Class II (performance standards). (a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain). (b) Classification. Class II (performance standards). (a) Identification. An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances (e.g., severe depression) by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §882.3. [44 FR 51730–51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987] (a) Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see §870.3300. (b) Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see §882.1(e). [69 FR 77900, Dec. 29, 2004] (a) Identification. Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position. (b) Classification. Class II (performance standards). (a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. (b) Classification. Class II (special controls) (prescription use in accordance with §801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)). [63 FR 40651, July 30, 1998] (a) Identification. Human dura mater is human pachymeninx tissue intended to repair defects in human dura mater. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Human Dura Mater.” See §882.1(e) for the availability of this guidance. [68 FR 70436, Dec. 18, 2003]
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Section Contents
§ 882.1 Scope.
§ 882.3 Effective dates of requirement for premarket approval.
§ 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 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.
§ 882.4030 Skull plate anvil.
§ 882.4060 Ventricular cannula.
§ 882.4100 Ventricular catheter.
§ 882.4125 Neurosurgical chair.
§ 882.4150 Scalp clip.
§ 882.4175 Aneurysm clip applier.
§ 882.4190 Clip forming/cutting instrument.
§ 882.4200 Clip removal instrument.
§ 882.4215 Clip rack.
§ 882.4250 Cryogenic surgical device.
§ 882.4275 Dowel cutting instrument.
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
§ 882.4325 Cranial drill handpiece (brace).
§ 882.4360 Electric cranial drill motor.
§ 882.4370 Pneumatic cranial drill motor.
§ 882.4400 Radiofrequency lesion generator.
§ 882.4440 Neurosurgical headrests.
§ 882.4460 Neurosurgical head holder (skull clamp).
§ 882.4500 Cranioplasty material forming instrument.
§ 882.4525 Microsurgical instrument.
§ 882.4535 Nonpowered neurosurgical instrument.
§ 882.4545 Shunt system implantation instrument.
§ 882.4560 Stereotaxic instrument.
§ 882.4600 Leukotome.
§ 882.4650 Neurosurgical suture needle.
§ 882.4700 Neurosurgical paddie.
§ 882.4725 Radiofrequency lesion probe.
§ 882.4750 Skull punch.
§ 882.4800 Self-retaining retractor for neurosurgery.
§ 882.4840 Manual rongeur.
§ 882.4845 Powered rongeur.
§ 882.4900 Skullplate screwdriver.
§ 882.5030 Methyl methacrylate for aneurysmorrhaphy.
§ 882.5050 Biofeedback device.
§ 882.5070 Bite block.
§ 882.5150 Intravascular occluding catheter.
§ 882.5175 Carotid artery clamp.
§ 882.5200 Aneurysm clip.
§ 882.5225 Implanted malleable clip.
§ 882.5235 Aversive conditioning device.
§ 882.5250 Burr hole cover.
§ 882.5275 Nerve cuff.
§ 882.5300 Methyl methacrylate for cranioplasty.
§ 882.5320 Preformed alterable cranioplasty plate.
§ 882.5330 Preformed nonalterable cranioplasty plate.
§ 882.5360 Cranioplasty plate fastener.
§ 882.5500 Lesion temperature monitor.
§ 882.5550 Central nervous system fluid shunt and components.
§ 882.5800 Cranial electrotheraphy stimulator.
§ 882.5810 External functional neuromuscular stimulator.
§ 882.5820 Implanted cerebellar stimulator.
§ 882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
§ 882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
§ 882.5850 Implanted spinal cord stimulator for bladder evacuation.
§ 882.5860 Implanted neuromuscular stimulator.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
§ 882.5900 Preformed craniosynostosis strip.
§ 882.5910 Dura substitute.
§ 882.5940 Electroconvulsive therapy device.
§ 882.5950 Neurovascular embolization device.
§ 882.5960 Skull tongs for traction.
§ 882.5970 Cranial orthosis.
§ 882.5975 Human dura mater.
Subpart A—General Provisions
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§ 882.1 Scope.
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§ 882.3 Effective dates of requirement for premarket approval.
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§ 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B—Neurological Diagnostic Devices
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§ 882.1020 Rigidity analyzer.
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§ 882.1030 Ataxiagraph.
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§ 882.1200 Two-point discriminator.
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§ 882.1240 Echoencephalograph.
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§ 882.1275 Electroconductive media.
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§ 882.1310 Cortical electrode.
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§ 882.1320 Cutaneous electrode.
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§ 882.1330 Depth electrode.
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§ 882.1340 Nasopharyngeal electrode.
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§ 882.1350 Needle electrode.
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§ 882.1400 Electroencephalograph.
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§ 882.1410 Electroencephalograph electrode/lead tester.
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§ 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
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§ 882.1430 Electroencephalograph test signal generator.
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§ 882.1460 Nystagmograph.
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§ 882.1480 Neurological endoscope.
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§ 882.1500 Esthesiometer.
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§ 882.1525 Tuning fork.
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§ 882.1540 Galvanic skin response measurement device.
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§ 882.1550 Nerve conduction velocity measurement device.
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§ 882.1560 Skin potential measurement device.
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§ 882.1570 Powered direct-contact temperature measurement device.
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§ 882.1610 Alpha monitor.
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§ 882.1620 Intracranial pressure monitoring device.
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§ 882.1700 Percussor.
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§ 882.1750 Pinwheel.
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§ 882.1790 Ocular plethysmograph.
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§ 882.1825 Rheoencephalograph.
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§ 882.1835 Physiological signal amplifier.
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§ 882.1845 Physiological signal conditioner.
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§ 882.1855 Electroencephalogram (EEG) telemetry system.
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§ 882.1870 Evoked response electrical stimulator.
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§ 882.1880 Evoked response mechanical stimulator.
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§ 882.1890 Evoked response photic stimulator.
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§ 882.1900 Evoked response auditory stimulator.
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§ 882.1925 Ultrasonic scanner calibration test block.
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§ 882.1950 Tremor transducer.
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Subparts C–D [Reserved]
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Subpart E—Neurological Surgical Devices
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§ 882.4030 Skull plate anvil.
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§ 882.4060 Ventricular cannula.
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§ 882.4100 Ventricular catheter.
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§ 882.4125 Neurosurgical chair.
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§ 882.4150 Scalp clip.
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§ 882.4175 Aneurysm clip applier.
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§ 882.4190 Clip forming/cutting instrument.
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§ 882.4200 Clip removal instrument.
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§ 882.4215 Clip rack.
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§ 882.4250 Cryogenic surgical device.
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§ 882.4275 Dowel cutting instrument.
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§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
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§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
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§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
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§ 882.4325 Cranial drill handpiece (brace).
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§ 882.4360 Electric cranial drill motor.
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§ 882.4370 Pneumatic cranial drill motor.
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§ 882.4400 Radiofrequency lesion generator.
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§ 882.4440 Neurosurgical headrests.
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§ 882.4460 Neurosurgical head holder (skull clamp).
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§ 882.4500 Cranioplasty material forming instrument.
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§ 882.4525 Microsurgical instrument.
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§ 882.4535 Nonpowered neurosurgical instrument.
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§ 882.4545 Shunt system implantation instrument.
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§ 882.4560 Stereotaxic instrument.
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§ 882.4600 Leukotome.
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§ 882.4650 Neurosurgical suture needle.
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§ 882.4700 Neurosurgical paddie.
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§ 882.4725 Radiofrequency lesion probe.
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§ 882.4750 Skull punch.
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§ 882.4800 Self-retaining retractor for neurosurgery.
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§ 882.4840 Manual rongeur.
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§ 882.4845 Powered rongeur.
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§ 882.4900 Skullplate screwdriver.
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Subpart F—Neurological Therapeutic Devices
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§ 882.5030 Methyl methacrylate for aneurysmorrhaphy.
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§ 882.5050 Biofeedback device.
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§ 882.5070 Bite block.
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§ 882.5150 Intravascular occluding catheter.
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§ 882.5175 Carotid artery clamp.
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§ 882.5200 Aneurysm clip.
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§ 882.5225 Implanted malleable clip.
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§ 882.5235 Aversive conditioning device.
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§ 882.5250 Burr hole cover.
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§ 882.5275 Nerve cuff.
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§ 882.5300 Methyl methacrylate for cranioplasty.
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§ 882.5320 Preformed alterable cranioplasty plate.
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§ 882.5330 Preformed nonalterable cranioplasty plate.
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§ 882.5360 Cranioplasty plate fastener.
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§ 882.5500 Lesion temperature monitor.
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§ 882.5550 Central nervous system fluid shunt and components.
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§ 882.5800 Cranial electrotheraphy stimulator.
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§ 882.5810 External functional neuromuscular stimulator.
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§ 882.5820 Implanted cerebellar stimulator.
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§ 882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
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§ 882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
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§ 882.5850 Implanted spinal cord stimulator for bladder evacuation.
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§ 882.5860 Implanted neuromuscular stimulator.
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§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
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§ 882.5880 Implanted spinal cord stimulator for pain relief.
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§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
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§ 882.5900 Preformed craniosynostosis strip.
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§ 882.5910 Dura substitute.
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§ 882.5940 Electroconvulsive therapy device.
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§ 882.5950 Neurovascular embolization device.
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§ 882.5960 Skull tongs for traction.
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§ 882.5970 Cranial orthosis.
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§ 882.5975 Human dura mater.
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