In the USA federal law regulates the sale of Medical Devices through the US Food and Drug Administration (FDA). This is done to ensure safety and effectiveness. Devices which are permitted to be marketed for their intended use must either have a 510(k) or PMA clearance.
The MAG and More Apollo TMS Therapy System has 510(k) clearance (K180313) and is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
The use of devices for other than their FDA cleared intended use is considered as investigational. Such use is only permitted if the Investigational Device Exemption (IDE) guidelines have been followed. For full information on this, please consult the FDA's website Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.
All investigational devices must be labeled in accordance with the labeling provisions of the IDE regulations (§812.5) and must bear the statement "CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use."
Please note that transcranial magnetic stimulation (TMS, rTMS) is considered investigational in the USA except for the above cleared intended use.
Items marked with* are investigational devices and for research use only. CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.