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# Electromagnetic Compatibility Guidance Out
- URL: https://www.fdaweb.com/electromagnetic-compatibility-guidance-out/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136128

FDA has issued a guidance, *Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices*, to describe relevant information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. The [document](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM470201.pdf?ref=fdaweb.com) says that electrically-powered devices include those that are AC-powered, battery powered, and active implantable devices. For the purpose of the guidance, EMC is defined as the ability of a device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance, without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.

Typically, FDA says, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.