21 CFR 882.5802 — Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5802
Identification
A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | 2 | 9 | SaMD |
| QMD | Transcranial Magnetic Stimulation System For Smoking Cessation | 2 | 2 |
Special Controls
QCI — Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
In combination with the general controls of the FD&C Act, the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is subject to the following special controls:
De Novo Order DEN170078
QCI — Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
*Classification.* Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic pulse output testing; (ii) Magnetic and electrical field testing; (iii) Testing of the safety features built into the device; and (iv) Testing of the sound levels patients are exposed to during device use. (5) The physician and patient labeling must include the following: (i) The risks and benefits associated with use of the device; (ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and (iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.
eCFR
QCI — Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic pulse output testing; (ii) Magnetic and electrical field testing; (iii) Testing of the safety features built into the device; and (iv) Testing of the sound levels patients are exposed to during device use. (5) The physician and patient labeling must include the following: (i) The risks and benefits associated with use of the device; (ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and (iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.
Ecfr Llm
QMD — Transcranial Magnetic Stimulation System For Smoking Cessation
*Classification.* Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic pulse output testing; (ii) Magnetic and electrical field testing; (iii) Testing of the safety features built into the device; and (iv) Testing of the sound levels patients are exposed to during device use. (5) The physician and patient labeling must include the following: (i) The risks and benefits associated with use of the device; (ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and (iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.
eCFR
