Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

On 19 May 2021 the FDA published this final guidance for industry and FDA staff.

This guidance document provides FDA'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.

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