Assessment of Radiofrequency-Induced Heating in the Magnetic
Resonance Environment for Multi-Configuration Passive Medical Devices;
Draft Guidance for Industry and Food and Drug Administration Staff;
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the assessment of RF-induced heating of multi-component, or multi-configuration, passive medical devices in the MR environment. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
For more inforamtion go to FDA