Magstim in North America
Regulation in North America
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 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 procedure, please consult the relevant page on the FDA's web site.
All investigational devices must be labeled as follows:
CAUTION: Investigational Device. Federal or (United States) law limits device to investigational use.
For more information about the FDA's work, please visit their official website: www.fda.gov
Please note that TMS is not approved for use in the USA.
