This guidance document provides Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance applies to all medical devices that might be used in the MR environment. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment | FDA
Testing and Labeling for Safety in Magnetic Resonance Environment
This guidance makes recommendations on testing the safety of medical devices in the magnetic resonance environment and the safety information in the labeling.
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