Electromagnetic Compatibility (EMC) of Medical Devices

6 June 2022 — FDA issued guidance on EMC for industry and FDA staff.

This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the labeling. This guidance applies to medical devices, including in vitro diagnostics, and accessories that are electrically powered or have functions or sensors that are implemented using electrical or electronic circuitry. The recommendations are intended to promote consistency and facilitate efficient review of electromagnetic compatibility in device submissions.