e-CFR Navigation Aids


Simple Search

Advanced Search

 — Boolean

 — Proximity


Search History

Search Tips


Latest Updates

User Info


Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 882Subpart F → §882.5802

Title 21: Food and Drugs
Subpart F—Neurological Therapeutic Devices

§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]

Need assistance?