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Medical Devices / Regulatory Affairs

FDA Releases Guidance on Testing and Labeling Devices in the MR Environment

Aug. 5, 2019
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The FDA has issued its recommendations for safety and compatibility assessments of medical devices in the magnetic resonance (MR) environment and the format of MRI safety information in labeling.

“This draft guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices,” the agency said.

The guidance applies to all implanted devices, devices intended to enter the MR environment, and external devices carried by or attached to a patient, such as an external insulin pump.

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