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# Draft Guide on Device Electromagnetic Compatibility
- URL: https://www.fdaweb.com/draft-guide-on-device-electromagnetic-compatibility/
- Published: 2020-11-16T12:00:00.000Z
- Updated: 2026-09-14T16:36:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148092

FDA has made available a [draft guidance](https://www.fda.gov/media/143716/download?ref=fdaweb.com) entitled *Electromagnetic Compatibility* *(EMC) of Medical Devices*. The document provides recommendations about information that should be provided in medical device submissions to demonstrate the EMC for electrically powered devices with electrical or electronic functions. The agency says that typically the review of EMC information in a submission is based on the risk associated with malfunction or degradation of the medical device under consideration, where malfunction or degradation could be caused by inadequate EMC. The review is also based on the use of appropriate consensus standards, it says.