New draft guidance on MR compatibility for medical devices

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."

Once finalized, this document will supersede FDA's 2014 guidance titled "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" and will complement FDA's 2016 guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices."

Although some of the general principles of the original 2014 guidance are retained, the new draft has been significantly expanded to:

  • Provide more guidance regarding how to apply the standardized test methods in terms of specifying the worst-case device and when testing is not needed.
  • Include considerations specific to electrically active devices.
  • Include nonimplanted devices that are expected to enter the MR suite.
  • Expand the required content of MR Conditional labeling.

Read More: New draft guidance on MR compatibility for medical devices

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