FDA Issues Final Guidance on Testing/Labeling of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has released the final version of its Guidance on ensuring the safety of medical devices used in proximity to magnetic resonance imaging (MRI) equipment.

Published in mid-October, the Final Guidance, titled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,” provides recommendations on MRI safety and compatibility assessments and labeling information to be included in premarket submissions and applications for medical device approval. The recommendations in the Guidance are consistent with the requirements detailed in ASTM F2503, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.”

According to the FDA, the Guidance is applicable to all medical devices that might be used in the MR environment, including implanted medical devices and medical devices fastened to or carried by a patient, such as an external insulin pump or a pulse oximeter. The Guidance is not applicable to the MR system itself or MR system components, including spacing pads and coils.

Read the complete text of the FDA’s Final Guidance on the testing and labeling of medical devices used in an MR environment.

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