FDA Issues Guidance on Medical Device Safety in MRI Facilities

The U.S. Food and Drug Administration (FDA) has issued its final guidance on assessing the safety of medical devices used in facilities using magnetic resonance imaging (MRI) technologies.

Published in late May in the U.S. Federal Register, the Guidance, entitled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,” is intended to cover implanted medical devices, external medical devices such as insulin pumps and oximeters that are fastened to or carried by patients entering a room where MRI scans are conducted, or other medical devices that may be used by healthcare professionals during MRI scans.

In addition to providing recommendations for addressing potential safety hazards associated with medical devices used in the MR environment, the guidance also includes safety labeling information that should be included in device premarket submissions.

Read the FDA’s guidance on the testing and labeling of medical devices used in MR environments.

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