21 CFR 882.5805

§ 882.5805 Repetitive transcranial magnetic stimulation system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 882.5805, § 882.5805 Repetitive transcranial magnetic stimulation system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90740
Permanent ID: ys:prov:90740@1
SHA-256: d957393fe1004c24356ff7140fb891330cea86c7dabbe6194ad0a1ecb32105c8

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.