Draft Guidance for Industry and FDA Staff
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices
This draft guidance document is being distributed for comment purposes only.
Document issued on June 29, 2015.
When finalized this guidance will provide industry with an assessment paradigm for radiofrequency (RF)-induced heating on or near 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 is typically not possible 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 a non-linear 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.
This document provides an approach to reduce the number of possible device configurations or combinations to a manageable number for the testing of RF-induced heating in the MR environment. Additionally, this document provides guidance on how to assess RF-induced device heating for multi-configuration passive medical devices. The information provided in this guidance is intended to be used to support MR conditional labeling claims in conjunction with the information provided in FDA’s current guidance document for Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu 90 ments/UCM107708.pdf).
FDA’s guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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Last Updated: June 29, 2015