CDRH Industry: Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Guidance for Industry and FDA Staff

The U.S. Food and Drug Administration has issued the final guidance titled, "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices."  This guidance provides an assessment paradigm for radiofrequency (RF)-induced heating for multi-configuration passive medical devices in the magnetic resonance (MR) environment, including multi-component and single-component device types with various dimensions and shape.