Change is on the Horizon for MRI Safety Labeling of Medical Devices

It is important for individuals involved in regulatory affairs to be aware of changes to MRI safety labeling requirements for medical devices. Participants will become aware of the fundamental MRI safety concerns (i.e., force, torque, image artifact, and RF heating), the corresponding standard test methods, and how the results from the testing form the MRI safety label that is reported in the instructions for use (IFU) for medical devices. In addition to these key points, participants will learn how the labeling requirements have changed and how to implement these changes in upcoming regulatory submissions.

Learning Objectives:

• describe the primary four MRI safety considerations for labeling in the IFU
• explain the "state-of-the-art" for MRI labeling information and format and understand the recent changes