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

Issue Date: March 22, 2016
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Anesthesiology , Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Cardiovascular , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Radiology, Labeling, Safety – Issues, Errors, and Problems
Status: Final

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

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. Multi-component passive devices, such as orthopedic fixation devices, may result in a very large number of possible device configurations and combinations of individual components. Single-component devices, such as cardiovascular stents, are also frequently available in multiple sizes or configurations. For these multi-configuration passive devices, it can be challenging to leverage RF-induced heating testing from one device configuration or combination to other device configurations or combinations because the geometry or configuration of the device can affect heating in an unknown manner. As a result, the total number of possible configurations or combinations that need to be assessed for RF-induced heating of some passive devices can be very large.

Download the Guidance Document