On 3 June, USFDA's Center for Devices and Radiological Health & Center for Biologics Evaluation and Research released updated guidance on "Electromagnetic Compatibility (EMC) of Medical Devices".
This document will supersede “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” issued July 11, 2016, 1 year after the publication of this guidance for in vitro diagnostics and 60 days after the publication of this guidance for other device types within the scope of this guidance.
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 an efficient review of electromagnetic compatibility in device submissions.
This guidance applies to medical devices, including in vitro diagnostic products, and accessories that:
• are electrically-powered; or
• have functions or sensors that are implemented using electrical or electronic circuitry
For electrically-powered medical devices and medical devices with electrical or electronic functions, you should provide evidence that the medical device is safe and performs as intended in the environments of use. This evidence includes risk management with regard to EM disturbances, testing, and labeling, as recommended in this guidance.