The U.S. Food and Drug Administration (FDA) has released final guidance on how facilities should assess the safety and compatibility of medical devices in the MRI suite and recommended format for MRI safety information in medical device labeling.
The document applies to all devices and appliances that might be used in an MRI environment, including implanted devices or external ones like insulin pumps or pulse oximeters. It does not apply to the MRI system or accessories.
The agency plans to host a webinar on June 24 for those interested in learning more about the guidance, it said.
