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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 882 - Neurological Devices |
| Subpart A - General Provisions |
| § 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). |
| Subpart B - Neurological Diagnostic Devices |
| § 882.1020 - Rigidity analyzer. |
| § 882.1030 - Ataxiagraph. |
| § 882.1200 - Two-point discriminator. |
| § 882.1240 - Echoencephalograph. |
| § 882.1275 - Electroconductive media. |
| § 882.1310 - Cortical electrode. |
| § 882.1320 - Cutaneous electrode. |
| § 882.1330 - Depth electrode. |
| § 882.1340 - Nasopharyngeal electrode. |
| § 882.1350 - Needle electrode. |
| § 882.1400 - Electroencephalograph. |
| § 882.1410 - Electroencephalograph electrode/lead tester. |
| § 882.1420 - Electroencephalogram (EEG) signal spectrum analyzer. |
| § 882.1430 - Electroencephalograph test signal generator. |
| § 882.1440 - Neuropsychiatric interpretive electroencephalograph assessment aid. |
| § 882.1450 - Brain injury adjunctive interpretive electroencephalograph assessment aid. |
| § 882.1455 - Traumatic brain injury eye movement assessment aid. |
| § 882.1460 - Nystagmograph. |
| § 882.1470 - Computerized cognitive assessment aid. |
| § 882.1471 - Computerized cognitive assessment aid for concussion. |
| § 882.1480 - Neurological endoscope. |
| § 882.1491 - Pediatric Autism Spectrum Disorder diagnosis aid. |
| § 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. |
| § 882.1561 - Evoked photon image capture device. |
| § 882.1570 - Powered direct-contact temperature measurement device. |
| § 882.1580 - Non-electroencephalogram (EEG) physiological signal based seizure monitoring system. |
| § 882.1610 - Alpha monitor. |
| § 882.1620 - Intracranial pressure monitoring device. |
| § 882.1630 - Cranial motion measurement 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. |
| § 882.1935 - Near Infrared (NIR) Brain Hematoma Detector. |
| § 882.1950 - Tremor transducer. |
| Subparts C--D - XXX |
| Subpart E - Neurological Surgical Devices |
| § 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. |
| § 882.4950 - Diagnostic neurosurgical microscope filter. |
| Subpart F - Neurological Therapeutic Devices |
| § 882.5030 - Methyl methacrylate for aneurysmorrhaphy. |
| § 882.5050 - Biofeedback device. |
| § 882.5060 - Conditioning tool for eating disorders. |
| § 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. |
| § 882.5560 - Cerebrospinal fluid shunt system. |
| § 882.5600 - Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment. |
| § 882.5700 - Thermal system for insomnia. |
| § 882.5705 - Digital therapy device to reduce sleep disturbance for psychiatric conditions. |
| § 882.5800 - Cranial electrotherapy stimulator. |
| § 882.5801 - Computerized behavioral therapy device for psychiatric disorders. |
| § 882.5802 - Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions. |
| § 882.5803 - Digital therapy device for Attention Deficit Hyperactivity Disorder. |
| § 882.5805 - Repetitive transcranial magnetic stimulation system. |
| § 882.5808 - Transcranial magnetic stimulator for headache. |
| § 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. |
| § 882.5855 - Brain stimulation programming planning software. |
| § 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. |
| § 882.5891 - Transcutaneous electrical nerve stimulator to treat headache. |
| § 882.5892 - External vagal nerve stimulator for headache. |
| § 882.5893 - Thermal vestibular stimulator for headache. |
| § 882.5894 - Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. |
| § 882.5895 - Vibratory counter-stimulation device. |
| § 882.5896 - Percutaneous nerve stimulator for substance use disorders. |
| § 882.5897 - External upper limb tremor stimulator. |
| § 882.5898 - Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder. |
| § 882.5899 - Trunk and limb electrical stimulator to treat headache. |
| § 882.5900 - Preformed craniosynostosis strip. |
| § 882.5910 - Dura substitute. |
| § 882.5940 - Electroconvulsive therapy device. |
| § 882.5950 - Neurovascular embolization device. |
| § 882.5955 - Temporary coil embolization assist device. |
| § 882.5960 - Skull tongs for traction. |
| § 882.5970 - Cranial orthosis. |
| § 882.5975 - Human dura mater. |