FDA Guidance on MR Passive Implants

CDRH issued a guidance for industry and FDA staff titled "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", which addresses the testing and labeling of passive implants. In preparing PMA, IDE, and 510(k) submissions, the guidance applies to MR devices that serve their function without electric power supply.

October 10, 2008

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FDA Guidance on MR Passive Implants

Active implants or devices that are not implants are not within the device's scope.The guidance says the main issues affecting passive implant safety and compatibility in the MR environment concern magnetically induced displacement force and torque, radio-frequency heating, and image artifacts. The document scope, MR testing, and labeling.--James G. Dickinson

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