FDA Issues Advice on Testing and Labeling Medical Devices for Safety Around MRIs

May 20, 2021

The FDA has issued guidance for device sponsors on testing to assess the safety and compatibility of electrically active medical devices used during magnetic resonance imaging (MRI) and on labeling of MRI safety information for such devices.

For electrically active devices that are intended to function during MRI procedures — for example, a device that is intended to monitor the patient or deliver therapy —the agency said sponsors should conduct appropriate testing or simulations to “demonstrate safe use and intended performance during the MR procedure.”

This is important due to the presence of higher electromagnetic interference risks both from the MR system as well as the sensitivity of MR systems to radiofrequency noise from active devices, the agency said.

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