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Title 21

Displaying title 21, up to date as of 7/16/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 882Neurological Devices882.1 – 882.5970
Subpart FNeurological Therapeutic Devices882.5030 – 882.5970
§ 882.5030Methyl methacrylate for aneurysmorrhaphy.
§ 882.5050Biofeedback device.
§ 882.5060Conditioning tool for eating disorders.
§ 882.5070Bite block.
§ 882.5150Intravascular occluding catheter.
§ 882.5175Carotid artery clamp.
§ 882.5200Aneurysm clip.
§ 882.5225Implanted malleable clip.
§ 882.5235Aversive conditioning device.
§ 882.5250Burr hole cover.
§ 882.5275Nerve cuff.
§ 882.5300Methyl methacrylate for cranioplasty.
§ 882.5320Preformed alterable cranioplasty plate.
§ 882.5330Preformed nonalterable cranioplasty plate.
§ 882.5360Cranioplasty plate fastener.
§ 882.5500Lesion temperature monitor.
§ 882.5550Central nervous system fluid shunt and components.
§ 882.5560Cerebrospinal fluid shunt system.
§ 882.5600Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
§ 882.5700Thermal system for insomnia.
§ 882.5705Digital therapy device to reduce sleep disturbance for psychiatric conditions.
§ 882.5800Cranial electrotherapy stimulator.
§ 882.5801Computerized behavioral therapy device for psychiatric disorders.
§ 882.5802Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
§ 882.5803Digital therapy device for Attention Deficit Hyperactivity Disorder.
§ 882.5804Computerized behavioral therapy device for the treatment of fibromyalgia symptoms.
§ 882.5805Repetitive transcranial magnetic stimulation system.
§ 882.5808Transcranial magnetic stimulator for headache.
§ 882.5810External functional neuromuscular stimulator.
§ 882.5820Implanted cerebellar stimulator.
§ 882.5830Implanted diaphragmatic/phrenic nerve stimulator.
§ 882.5840Implanted intracerebral/subcortical stimulator for pain relief.
§ 882.5850Implanted spinal cord stimulator for bladder evacuation.
§ 882.5855Brain stimulation programming planning software.
§ 882.5860Implanted neuromuscular stimulator.
§ 882.5870Implanted peripheral nerve stimulator for pain relief.
§ 882.5880Implanted spinal cord stimulator for pain relief.
§ 882.5887External lower extremity nerve stimulator for Restless Legs Syndrome.
§ 882.5888Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
§ 882.5889Electrical tongue nerve stimulator to treat motor deficits.
§ 882.5890Transcutaneous electrical nerve stimulator for pain relief.
§ 882.5891Transcutaneous electrical nerve stimulator to treat headache.
§ 882.5892External vagal nerve stimulator for headache.
§ 882.5893Thermal vestibular stimulator for headache.
§ 882.5894Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
§ 882.5895Vibratory counter-stimulation device.
§ 882.5896Percutaneous nerve stimulator for substance use disorders.
§ 882.5897External upper limb tremor stimulator.
§ 882.5898Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
§ 882.5899Trunk and limb electrical stimulator to treat headache.
§ 882.5900Preformed craniosynostosis strip.
§ 882.5910Dura substitute.
§ 882.5940Electroconvulsive therapy device.
§ 882.5950Neurovascular embolization device.
§ 882.5955Temporary coil embolization assist device.
§ 882.5960Skull tongs for traction.
§ 882.5970Cranial orthosis.