Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple guidances.
A magnetic resonance diagnostic device is intended for general diagnostic use to present images that reflect the spatial distribution and/or magnetic resonance spectra that reflect the frequency and distribution of nuclei exhibiting nuclear magnetic resonance.
MRDDs are Class II medical devices that require premarket notification and an agency determination of substantial equivalence prior to marketing.
Three product codes are currently used to identify these devices:
LNH – Nuclear Magnetic Resonance Imaging System
LNI – Nuclear Magnetic Resonance Spectroscopic System
MOS - Magnetic Resonance Specialty Coil
This guidance applies to premarket notifications for magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) systems, components, and accessories, as well as modifications to systems, components, and accessories, which might significantly impact the safety or effectiveness of the MRDD and require a premarket notification submission before marketing. This guidance provides the FDA's recommendations on the information to support premarket submissions for a magnetic resonance diagnostic device (MRDD).
Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
This FDA's guidance provides recommendations on testing medical devices in magnetic resonance (MR) environments for their safety and compatibility, and on the format for magnetic resonance imaging safety information on medical devices.
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