Guide on Device Electromagnetic Compatibility Considerations

FDA has released a final guidance entitled “Electromagnetic Compatibility (EMC)of Medical Devices” that offers the agency’s current thinking on recommended information that should be provided in a premarket submission to demonstrate EMC for electrically powered medical devices and medical devices with electrical or electronic functions. The document says the review of EMC information in a submission is based on the risk associated with a device malfunction or degradation, where malfunction or degradation could be caused by inadequate EMC. The review is also based on the use of appropriate consensus standards. The guidance is intended to replace an agency guidance entitled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” in one year for in vitro diagnostics and 60 days for other device types.