Title 21

PART 882

Part 882 - Neurological Devices

PART 882 - NEUROLOGICAL DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:44 FR 51730, Sept. 4, 1979, unless otherwise noted. Editorial Note:Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.28.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.28.1.1.1SECTION 882.1
   882.1 Scope.
21:8.0.1.1.28.1.1.2SECTION 882.3
   882.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.28.1.1.3SECTION 882.9
   882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.28.2SUBPART B
Subpart B - Neurological Diagnostic Devices
21:8.0.1.1.28.2.1.1SECTION 882.1020
   882.1020 Rigidity analyzer.
21:8.0.1.1.28.2.1.2SECTION 882.1030
   882.1030 Ataxiagraph.
21:8.0.1.1.28.2.1.3SECTION 882.1200
   882.1200 Two-point discriminator.
21:8.0.1.1.28.2.1.4SECTION 882.1240
   882.1240 Echoencephalograph.
21:8.0.1.1.28.2.1.5SECTION 882.1275
   882.1275 Electroconductive media.
21:8.0.1.1.28.2.1.6SECTION 882.1310
   882.1310 Cortical electrode.
21:8.0.1.1.28.2.1.7SECTION 882.1320
   882.1320 Cutaneous electrode.
21:8.0.1.1.28.2.1.8SECTION 882.1330
   882.1330 Depth electrode.
21:8.0.1.1.28.2.1.9SECTION 882.1340
   882.1340 Nasopharyngeal electrode.
21:8.0.1.1.28.2.1.10SECTION 882.1350
   882.1350 Needle electrode.
21:8.0.1.1.28.2.1.11SECTION 882.1400
   882.1400 Electroencephalograph.
21:8.0.1.1.28.2.1.12SECTION 882.1410
   882.1410 Electroencephalograph electrode/lead tester.
21:8.0.1.1.28.2.1.13SECTION 882.1420
   882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
21:8.0.1.1.28.2.1.14SECTION 882.1430
   882.1430 Electroencephalograph test signal generator.
21:8.0.1.1.28.2.1.15SECTION 882.1440
   882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.
21:8.0.1.1.28.2.1.16SECTION 882.1450
   882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
21:8.0.1.1.28.2.1.17SECTION 882.1460
   882.1460 Nystagmograph.
21:8.0.1.1.28.2.1.18SECTION 882.1470
   882.1470 Computerized cognitive assessment aid.
21:8.0.1.1.28.2.1.19SECTION 882.1471
   882.1471 Computerized cognitive assessment aid for concussion.
21:8.0.1.1.28.2.1.20SECTION 882.1480
   882.1480 Neurological endoscope.
21:8.0.1.1.28.2.1.21SECTION 882.1500
   882.1500 Esthesiometer.
21:8.0.1.1.28.2.1.22SECTION 882.1525
   882.1525 Tuning fork.
21:8.0.1.1.28.2.1.23SECTION 882.1540
   882.1540 Galvanic skin response measurement device.
21:8.0.1.1.28.2.1.24SECTION 882.1550
   882.1550 Nerve conduction velocity measurement device.
21:8.0.1.1.28.2.1.25SECTION 882.1560
   882.1560 Skin potential measurement device.
21:8.0.1.1.28.2.1.26SECTION 882.1561
   882.1561 Evoked photon image capture device.
21:8.0.1.1.28.2.1.27SECTION 882.1570
   882.1570 Powered direct-contact temperature measurement device.
21:8.0.1.1.28.2.1.28SECTION 882.1580
   882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
21:8.0.1.1.28.2.1.29SECTION 882.1610
   882.1610 Alpha monitor.
21:8.0.1.1.28.2.1.30SECTION 882.1620
   882.1620 Intracranial pressure monitoring device.
21:8.0.1.1.28.2.1.31SECTION 882.1630
   882.1630 Cranial motion measurement device.
21:8.0.1.1.28.2.1.32SECTION 882.1700
   882.1700 Percussor.
21:8.0.1.1.28.2.1.33SECTION 882.1750
   882.1750 Pinwheel.
21:8.0.1.1.28.2.1.34SECTION 882.1790
   882.1790 Ocular plethysmograph.
21:8.0.1.1.28.2.1.35SECTION 882.1825
   882.1825 Rheoencephalograph.
21:8.0.1.1.28.2.1.36SECTION 882.1835
   882.1835 Physiological signal amplifier.
21:8.0.1.1.28.2.1.37SECTION 882.1845
   882.1845 Physiological signal conditioner.
21:8.0.1.1.28.2.1.38SECTION 882.1855
   882.1855 Electroencephalogram (EEG) telemetry system.
21:8.0.1.1.28.2.1.39SECTION 882.1870
   882.1870 Evoked response electrical stimulator.
21:8.0.1.1.28.2.1.40SECTION 882.1880
   882.1880 Evoked response mechanical stimulator.
21:8.0.1.1.28.2.1.41SECTION 882.1890
   882.1890 Evoked response photic stimulator.
21:8.0.1.1.28.2.1.42SECTION 882.1900
   882.1900 Evoked response auditory stimulator.
21:8.0.1.1.28.2.1.43SECTION 882.1925
   882.1925 Ultrasonic scanner calibration test block.
21:8.0.1.1.28.2.1.44SECTION 882.1935
   882.1935 Near Infrared (NIR) Brain Hematoma Detector.
21:8.0.1.1.28.2.1.45SECTION 882.1950
   882.1950 Tremor transducer.
21:8.0.1.1.28.3SUBPART C
Subparts C-D [Reserved]
21:8.0.1.1.28.4SUBPART E
Subpart E - Neurological Surgical Devices
21:8.0.1.1.28.4.1.1SECTION 882.4030
   882.4030 Skull plate anvil.
21:8.0.1.1.28.4.1.2SECTION 882.4060
   882.4060 Ventricular cannula.
21:8.0.1.1.28.4.1.3SECTION 882.4100
   882.4100 Ventricular catheter.
21:8.0.1.1.28.4.1.4SECTION 882.4125
   882.4125 Neurosurgical chair.
21:8.0.1.1.28.4.1.5SECTION 882.4150
   882.4150 Scalp clip.
21:8.0.1.1.28.4.1.6SECTION 882.4175
   882.4175 Aneurysm clip applier.
21:8.0.1.1.28.4.1.7SECTION 882.4190
   882.4190 Clip forming/cutting instrument.
21:8.0.1.1.28.4.1.8SECTION 882.4200
   882.4200 Clip removal instrument.
21:8.0.1.1.28.4.1.9SECTION 882.4215
   882.4215 Clip rack.
21:8.0.1.1.28.4.1.10SECTION 882.4250
   882.4250 Cryogenic surgical device.
21:8.0.1.1.28.4.1.11SECTION 882.4275
   882.4275 Dowel cutting instrument.
21:8.0.1.1.28.4.1.12SECTION 882.4300
   882.4300 Manual cranial drills, burrs, trephines, and their accessories
21:8.0.1.1.28.4.1.13SECTION 882.4305
   882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
21:8.0.1.1.28.4.1.14SECTION 882.4310
   882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
21:8.0.1.1.28.4.1.15SECTION 882.4325
   882.4325 Cranial drill handpiece (brace).
21:8.0.1.1.28.4.1.16SECTION 882.4360
   882.4360 Electric cranial drill motor.
21:8.0.1.1.28.4.1.17SECTION 882.4370
   882.4370 Pneumatic cranial drill motor.
21:8.0.1.1.28.4.1.18SECTION 882.4400
   882.4400 Radiofrequency lesion generator.
21:8.0.1.1.28.4.1.19SECTION 882.4440
   882.4440 Neurosurgical headrests.
21:8.0.1.1.28.4.1.20SECTION 882.4460
   882.4460 Neurosurgical head holder (skull clamp).
21:8.0.1.1.28.4.1.21SECTION 882.4500
   882.4500 Cranioplasty material forming instrument.
21:8.0.1.1.28.4.1.22SECTION 882.4525
   882.4525 Microsurgical instrument.
21:8.0.1.1.28.4.1.23SECTION 882.4535
   882.4535 Nonpowered neurosurgical instrument.
21:8.0.1.1.28.4.1.24SECTION 882.4545
   882.4545 Shunt system implantation instrument.
21:8.0.1.1.28.4.1.25SECTION 882.4560
   882.4560 Stereotaxic instrument.
21:8.0.1.1.28.4.1.26SECTION 882.4600
   882.4600 Leukotome.
21:8.0.1.1.28.4.1.27SECTION 882.4650
   882.4650 Neurosurgical suture needle.
21:8.0.1.1.28.4.1.28SECTION 882.4700
   882.4700 Neurosurgical paddie.
21:8.0.1.1.28.4.1.29SECTION 882.4725
   882.4725 Radiofrequency lesion probe.
21:8.0.1.1.28.4.1.30SECTION 882.4750
   882.4750 Skull punch.
21:8.0.1.1.28.4.1.31SECTION 882.4800
   882.4800 Self-retaining retractor for neurosurgery.
21:8.0.1.1.28.4.1.32SECTION 882.4840
   882.4840 Manual rongeur.
21:8.0.1.1.28.4.1.33SECTION 882.4845
   882.4845 Powered rongeur.
21:8.0.1.1.28.4.1.34SECTION 882.4900
   882.4900 Skullplate screwdriver.
21:8.0.1.1.28.5SUBPART F
Subpart F - Neurological Therapeutic Devices
21:8.0.1.1.28.5.1.1SECTION 882.5030
   882.5030 Methyl methacrylate for aneurysmorrhaphy.
21:8.0.1.1.28.5.1.2SECTION 882.5050
   882.5050 Biofeedback device.
21:8.0.1.1.28.5.1.3SECTION 882.5070
   882.5070 Bite block.
21:8.0.1.1.28.5.1.4SECTION 882.5150
   882.5150 Intravascular occluding catheter.
21:8.0.1.1.28.5.1.5SECTION 882.5175
   882.5175 Carotid artery clamp.
21:8.0.1.1.28.5.1.6SECTION 882.5200
   882.5200 Aneurysm clip.
21:8.0.1.1.28.5.1.7SECTION 882.5225
   882.5225 Implanted malleable clip.
21:8.0.1.1.28.5.1.8SECTION 882.5235
   882.5235 Aversive conditioning device.
21:8.0.1.1.28.5.1.9SECTION 882.5250
   882.5250 Burr hole cover.
21:8.0.1.1.28.5.1.10SECTION 882.5275
   882.5275 Nerve cuff.
21:8.0.1.1.28.5.1.11SECTION 882.5300
   882.5300 Methyl methacrylate for cranioplasty.
21:8.0.1.1.28.5.1.12SECTION 882.5320
   882.5320 Preformed alterable cranioplasty plate.
21:8.0.1.1.28.5.1.13SECTION 882.5330
   882.5330 Preformed nonalterable cranioplasty plate.
21:8.0.1.1.28.5.1.14SECTION 882.5360
   882.5360 Cranioplasty plate fastener.
21:8.0.1.1.28.5.1.15SECTION 882.5500
   882.5500 Lesion temperature monitor.
21:8.0.1.1.28.5.1.16SECTION 882.5550
   882.5550 Central nervous system fluid shunt and components.
21:8.0.1.1.28.5.1.17SECTION 882.5600
   882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
21:8.0.1.1.28.5.1.18SECTION 882.5700
   882.5700 Thermal system for insomnia.
21:8.0.1.1.28.5.1.19SECTION 882.5800
   882.5800 Cranial electrotherapy stimulator.
21:8.0.1.1.28.5.1.20SECTION 882.5801
   882.5801 Computerized behavioral therapy device for psychiatric disorders.
21:8.0.1.1.28.5.1.21SECTION 882.5802
   882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
21:8.0.1.1.28.5.1.22SECTION 882.5805
   882.5805 Repetitive transcranial magnetic stimulation system.
21:8.0.1.1.28.5.1.23SECTION 882.5808
   882.5808 Transcranial magnetic stimulator for headache.
21:8.0.1.1.28.5.1.24SECTION 882.5810
   882.5810 External functional neuromuscular stimulator.
21:8.0.1.1.28.5.1.25SECTION 882.5820
   882.5820 Implanted cerebellar stimulator.
21:8.0.1.1.28.5.1.26SECTION 882.5830
   882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
21:8.0.1.1.28.5.1.27SECTION 882.5840
   882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
21:8.0.1.1.28.5.1.28SECTION 882.5850
   882.5850 Implanted spinal cord stimulator for bladder evacuation.
21:8.0.1.1.28.5.1.29SECTION 882.5860
   882.5860 Implanted neuromuscular stimulator.
21:8.0.1.1.28.5.1.30SECTION 882.5870
   882.5870 Implanted peripheral nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.31SECTION 882.5880
   882.5880 Implanted spinal cord stimulator for pain relief.
21:8.0.1.1.28.5.1.32SECTION 882.5890
   882.5890 Transcutaneous electrical nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.33SECTION 882.5891
   882.5891 Transcutaneous electrical nerve stimulator to treat headache.
21:8.0.1.1.28.5.1.34SECTION 882.5892
   882.5892 External vagal nerve stimulator for headache.
21:8.0.1.1.28.5.1.35SECTION 882.5893
   882.5893 Thermal vestibular stimulator for headache.
21:8.0.1.1.28.5.1.36SECTION 882.5894
   882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
21:8.0.1.1.28.5.1.37SECTION 882.5895
   882.5895 Vibratory counter-stimulation device.
21:8.0.1.1.28.5.1.38SECTION 882.5896
   882.5896 Percutaneous nerve stimulator for substance use disorders.
21:8.0.1.1.28.5.1.39SECTION 882.5900
   882.5900 Preformed craniosynostosis strip.
21:8.0.1.1.28.5.1.40SECTION 882.5897
   882.5897 External upper limb tremor stimulator.
21:8.0.1.1.28.5.1.41SECTION 882.5910
   882.5910 Dura substitute.
21:8.0.1.1.28.5.1.42SECTION 882.5940
   882.5940 Electroconvulsive therapy device.
21:8.0.1.1.28.5.1.43SECTION 882.5950
   882.5950 Neurovascular embolization device.
21:8.0.1.1.28.5.1.44SECTION 882.5960
   882.5960 Skull tongs for traction.
21:8.0.1.1.28.5.1.45SECTION 882.5970
   882.5970 Cranial orthosis.
21:8.0.1.1.28.5.1.46SECTION 882.5975
   882.5975 Human dura mater.