FDA has developed this document to describe relevant information that should be provided in a premarket submission, (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification [510(k)] submissions, investigational device exemption (IDE) applications and de novo requests), to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. Electrically-powered devices include those that are AC (mains) powered devices, battery powered devices, and active implantable devices.

For the purpose of this document, EMC is defined as the ability of a device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference1), without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.