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GUIDANCE DOCUMENT

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 March 2016

Final

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

Docket Number:
FDA-2015-D-2104
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.


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All written comments should be identified with this document's docket number: FDA-2015-D-2104.