FDA Updates Guidance on Implant Safety for Patients Using MRIs

The FDA Dec. 11 issued a guidance addressing the safety and compatibility of certain devices when using magnetic resonance imaging.

The guidance’s name is “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.” Passive implants, the guidance says, are “implanted devices that serve their function without the supply of electronic power.” According to the document, the guidance supersedes an Aug. 21, 2008, guidance with the same title 2 MELR 560, 9/10/08.

The new guidance addresses testing and labeling of passive implants for safety and compatibility when using magnetic resonance imaging (MRI). It also said, “In ...