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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 stimu

lator. 882.5870 Implanted peripheral nerve stimu

lator 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 Artificial embolization device. 882.5960 Skull tongs for traction. 882.5970 Cranial orthosis.

AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360), 371.

SOURCE: 44 FR 51730–51778, Sept. 4, 1979, unless otherwise noted.

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. (52 FR 17739, May 11, 1987) 8882.3 Effective dates of requirement

for premarket approval. 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,

Subpart A-General Provisions

a

8882.1 Scope.

(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 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

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)

entific 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).

8882.9 Limitations of exemptions from

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). 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 differ from the inte ded 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 sci

[65 FR 2319, Jan. 14, 2000)

Subpart B-Neurological

Diagnostic Devices

8882.1020 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).

8882.1030 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).

8882.1310 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).

8882.1320 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).

$ 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 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)

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8 882.1240 Echoencephalograph. (a) Identification.

An echoencephalograph is an ultrasonic scanning device (including A-scan, Bscan, 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).

8882.1275 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).

8882.1400 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).

$ 882.1410 Electroencephalograph elec

trodeslead tester. (a) Identification.

An electroencephalograph electrode/lead

tester is a device used for testing the other examiner and which is used to impedance (resistance to alternating determine whether a patient has taccurrent) of the electrode and lead sys- tile sensitivity. tem of an electroencephalograph to as- (b) Classification. Class I (general consure that an adequate contact is made trols). The device is exempt from the between the electrode and the skin. premarket notification procedures in

(b) Classification. Class I. The device subpart E of part 807 of this chapter is exempt from the premarket notifica subject to $882.9. The device is also extion procedures in subpart E of part 807 empt from the current good manufacof this chapter.

turing practice regulations in part 820

of this chapter, with the exception of (44 FR 51730–51778, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996)

$ 820.180 of this chapter, with respect to

general requirements concerning 8882.1420 Electroencephalogram

records, and $820.198 of this chapter, (EEG) signal spectrum analyzer. with respect to complaint files. (a) Identification. An electroencepha- [44 FR 51730-51778, Sept. 4, 1979, as amended logram (EEG) signal spectrum analyzer

at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. is a device used to display the fre

14, 2000] quency content or power spectral den

8882.1525 Tuning fork. sity of the electroencephalogram (EEG) signal.

(a) Identification. A tuning fork is a (b) Classification. Class I (general con

mechanical device which resonates at a trols).

given frequency and is used to diagnose

hearing disorders and to test for vibra8 882.1430 Electroencephalograph test tory sense. signal generator.

(b) Classification. Class I. The device (a) Identification.

An

is exempt from the premarket notificaelectroencephalograph test signal gen

tion procedures in subpart E of part 807 erator is a device used to test or cali

of this chapter. The device is also exbrate an electroencephalograph.

empt from the current good manufac(b) Classification. Class I. The device

turing practice regulations in part 820 is exempt from the premarket notifica

of this chapter, with the exception of tion procedures in subpart E of part 807

$ 820.180, with respect to general reof this chapter.

quirements concerning records, and

8 820.198, with respect to complaint [44 FR 51730-51778, Sept. 4, 1979, as amended files. at 59 FR 63011, Dec. 7, 1994)

(44 FR 51730-51778, Sept. 4, 1979, as amended 8882.1460 Nystagmograph.

at 54 FR 25051, June 12, 1989) (a) Identification. A nystagmograph is $882.1540 Galvanic skin

response a device used to measure, record, or measurement device. visually display the involuntary move

(a) Identification. A galvanic skin rements (nystagmus) of the eyeball.

sponse measurement device is a device (b) Classification. Class II (perform

used to determine autonomic responses ance standards).

as psychological indicators by meas8882.1480 Neurological endoscope.

uring the electrical resistance of the

skin and the tissue path between two (a) Identification. A neurological en- electrodes applied to the skin. doscope is an instrument with a light (b) Classification. Class II (performsource used to view the inside of the

ance standards). ventricles of the brain.

(b) Classification. Class II (perform- $882.1550 Nerve conduction velocity ance standards).

measurement device,

(a) Identification. A nerve conduction $ 882.1500 Esthesiometer.

velocity measurement device is a de(a) Identification. An esthesiometer is vice which measures nerve conduction a mechanical device which usually con- time by applying a stimulus, usually to sists of a single rod or fiber which is a patient's peripheral nerve. This deheld in the fingers of the physician or vice includes the stimulator and the

electronic processing equipment for measuring and displaying the nerve conduction time.

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

of this chapter. 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)

8882.1560 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).

8882.1570 Powered direct-contact tem

perature measurement device. (a) Identification. A powered directcontact 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).

$ 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 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000) 8 882.1790 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 a PDP is required. No effective date has been established of the requirement for premarket approval. See 8882.3. [44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987)

a

8882.1610 Alpha monitor. (a) Identification. An alpha monitor is

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). 8882.1620 Intracranial pressure moni.

toring 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). 8 882.1700 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. The device is exempt from the premarket notification procedures in subpart E of part 807

$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

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