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FDA Issues Minor Updates to Guidances on Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Today, the U.S. Food and Drug Administration (FDA) is publishing updates to the following magnetic resonance (MR) related guidances, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, to harmonize with the latest edition of relevant FDA-recognized consensus standards. These updated guidances provide the FDA’s recommendations on testing and labeling that should be included in premarket submissions of MR diagnostic devices (MRDD) and compatibility of other medical devices in the MR environment.

Questions?

If you have questions about these guidances, contact the Division of Industry and Consumer Education.