Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff

Issue Date: October 10, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Labeling, Safety – Issues, Errors, and Problems
Status: Final

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff

This guidance document provides the FDA’s recommendations on testing to assess the safety and compatibility of medical devices in a magnetic resonance (MR) environment and the recommended format for magnetic resonance imaging safety information in medical device labeling. This guidance applies to all medical devices that might be used in the MR environment. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.

Download the Guidance Document