Guidance on Radiofrequency-Induced Heating of MR Devices

Federal Register Notice: FDA is making available a guidance entitled Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices. FDA is confronted with an increasing number of premarket submissions that include an MR conditional labeling claim for multiconfiguration passive medical devices. The assessment of radiofrequency (RF)-induced heating of such devices, typically comprised of many parts, strongly depends on the specific device geometry and can therefore lead to a prohibitively large number of test cases. This guidance provides an approach to reduce the number of possible device configurations to a manageable number, and it provides guidance on how to assess the RF-induced device heating for an individual configuration. To download this guidance, click here. To view this notice, click here.