CDRH Industry: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Draft Guidance for Industry and FDA Staff

A draft guidance has been posted titled, "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices."  The Food and Drug Administration (FDA) has developed this document to describe the types of information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. For the purpose of this document, EMC is defined as the ability of a device to function (a) properly in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference1), and (b) without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.