title: Medical devices; neurological devices; classification of repetitive transcranial magnetic stimulation system. Final rule.
abstract: The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D055909:Magnetic Field Therapy / Q000009:adverse effects / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration