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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2015-D-2104.