Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices

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Draft Guidance for Industry and Food and Drug Administration Staff;
Availability

This draft guidance is being issued consistent with FDA's good 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 The draft guidance, when 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

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