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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR882.5802]
See Related Information on Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart F--Neurological Therapeutic Devices

Sec. 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

(a) 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.

(b) 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.

[84 FR 9230, Mar. 14, 2019]

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