Transcranial Magnetic Stimulation - FDA Actions

FDA Actions

In January 2007 an advisory panel of the United States Food and Drug Administration (FDA) did not recommend clearance for marketing of an rTMS device, stating that the device appeared to be reasonably safe but had failed to demonstrate efficacy in a study of people with major depression who had not benefitted from prior adequate treatment with oral antidepressants during their current major depressive episode. The panel agreed that "unblinding was greater in the active group, and considering the magnitude of the effect size, it may have influenced the study results." However, the FDA determined in December 2008 that the rTMS device was sufficiently similar to existing devices that did not require a premarket approval application and allowed the device to be marketed in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for "the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode". The user manual for the device warns that effectiveness has not been established in patients with major depressive disorder who have failed to achieve satisfactory improvement from zero and from two or more antidepressant medications in the current episode and that the device has not been studied in patients who have had no prior antidepressant medication.

In July 2011 the FDA published a final rule in the Federal Register that classified the rTMS system into class II (special controls) (see: Medical device#Classification) "in order to provide a reasonable assurance of safety and effectiveness of these devices". The rule identified the rTMS system as "an external device that delivers transcranial 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". An FDA guidance document issued in conjunction with the final rule describes the special controls that support the classification of the rTMS system into Class II.