Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
This guidance applies to all medical devices that might be used in the MR environment, including implanted devices, devices fastened to or carried by patients, and devices intended to enter the MR environment. It provides recommendations for MRI safety and compatibility assessments and labeling information for premarket submissions. The guidance excludes MR systems and associated components.
Recommended Actions
- Determine device MR safety classification (Safe, Unsafe, or Conditional)
- Develop test plan based on device type and classification
- Conduct required safety testing according to applicable standards
- Document test results and develop appropriate labeling
- Include comprehensive MRI Safety Information section in device labeling
- Create patient device card for implants and patient-worn devices
- Submit complete test reports in premarket submission
- Consider seeking FDA feedback through Q-submission process if needed
- Ensure labeling is readily accessible throughout device lifetime
- Maintain documentation of MR safety evaluation and testing
Key Considerations
Non-clinical testing
- Testing for magnetically induced displacement force using ASTM F2052 for small devices
- Testing for magnetically induced torque using ASTM F2213
- Testing for RF-induced heating using ASTM F2182 for passive devices
- Testing for gradient-induced vibration for active implantable devices
- Testing for gradient-induced electrical potential for devices with electrodes
- Testing for RF pulse rectification for active devices with electrodes
- Testing for device malfunction in MR environment
- Testing for image artifacts using ASTM F2119
Labelling
- Must include MRI Safety Information section
- Must label device as MR Safe, MR Unsafe, or MR Conditional with appropriate symbol
- For MR Conditional devices, must specify conditions for safe use
- Must include patient device card for implants and patient-worn devices
- Must include information for both patients and healthcare providers
- Must include image artifact information
- Must include specific scan parameters and conditions when applicable
Safety
- Must address magnetically induced displacement force
- Must address magnetically induced torque
- Must address RF-induced heating
- Must address gradient-induced vibration
- Must address gradient-induced electrical potential
- Must address RF pulse rectification
- Must address device malfunction risks
- Must specify maximum allowed field strengths and exposure conditions
Other considerations
- Must consider device size and configuration for worst-case testing scenarios
- Must consider multiple MR field strengths (e.g., 1.5T, 3.0T)
- Must consider different RF coil types and configurations
- Must consider device location relative to MR bore
- Must consider cooling periods between scans when applicable
Relevant Guidances
- Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (Draft)
- Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
Related references and norms
- ASTM F2052: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2213: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- ISO/TS 10974: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
- IEC 60601-2-33: Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Original guidance
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- HTML / PDF
- Issue date: 2023-10-10
- Last changed date: 2023-10-10
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, Errors, and Problems, Labeling, Premarket, Safety - Issues
- ReguVirta summary file ID: 7f741a2bd682e52f2ee874669f9cc8f2
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