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

Title 21Chapter ISubchapter HPart 882Subpart F → §882.5805

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

§882.5805   Repetitive transcranial magnetic stimulation system.

(a) Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

(b) Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See §882.1(e) for the availability of this guidance document.

[76 FR 44491, July 26, 2011]

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