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Webinar Materials

• Presentation
• Printable Slides
• Transcript

Summary

On June 24, 2021, the U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. This guidance document provides the FDA's recommendations on testing to assess the safety and compatibility of medical devices in the MR Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. Ensuring the safety of patients who use magnetic resonance imaging (MRI) for disease diagnosis and health management is vital.

Background

On May 19, 2021, the FDA issued the final guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

During this webinar, the FDA will:

• Share information about the final guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.
• Answer your questions about the guidance.