Final FDA Guidance on Medical Device Electromagnetic Compatibility (ECM)
FDA has finalized a guidance on how manufacturers of electrically powered devices should prove Electromagnetic Compatibility for premarket clearance and approval.
Electrically powered devices include those that are battery powered and active implantable devices.
According to this guidance Electromagnetic Compatibility is defined as the ability of device to function safely and effectively in its intended electromagnetic environment.
The final guidance suggests that manufacturers should provide a summary of all testing conducting; they should demonstrate that the device is compliant with all standard specifications and they should describe how device functions have been tested.
FDA may ask additional information in case of specific active medical devices to ensure their electromagnetic compatibility.