Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
This guidance applies to Magnetic Resonance Diagnostic Devices (MRDDs) as defined in 21 CFR 892.1000, which are Class II medical devices requiring premarket notification. It covers MRI and MRS systems, components, accessories, and modifications that could significantly affect safety or effectiveness. The guidance also applies to MRI components of dual-modality devices like PET/MRI systems.
What You Need to Know? 👇
What are the key changes in the updated FDA guidance for MR device 510(k) submissions?
The main update harmonizes with IEC 60601-2-33 4th edition, redefining the main magnetic field hazard area from 0.5 mT to 0.9 mT as the controlled access boundary where static magnetic fields can cause harm.
Which NEMA standards are recognized by FDA for MR device performance testing?
FDA recognizes NEMA MS standards 1-6, 8-10, and 12, covering signal-to-noise ratio, geometric distortion, image uniformity, acoustic noise, slice thickness, SAR characterization, and phased array coil testing for diagnostic MRI systems.
What SAR testing is required for multi-channel transmit coils in 510(k) submissions?
You must measure local 10g-averaged SAR values, compare peak values to quadrature volume coils meeting IEC 60601-2-33 limits, and provide validation data with uncertainty boundaries for computational models used.
When does a pulse sequence modification require a new 510(k) submission?
New pulse sequences or modifications that change intended use (like metal artifact reduction) generally require 510(k) submission. Minor modifications to existing cleared sequences without affecting intended use typically don’t require new submissions.
What clinical image documentation is acceptable for 510(k) submissions?
You can provide sample DICOM images for all pulse sequences, or alternatively, a statement from a U.S. Board Certified radiologist attesting to diagnostic image quality, plus a representative subset of images.
What cybersecurity documentation is required for MR devices meeting cyber device definition?
If your device meets section 524B(c) cyber device definition, cybersecurity documentation under section 524B(b) is required, following FDA guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive performance testing according to recognized standards
- Develop detailed device description including all major components
- Implement and validate safety controls for RF energy, gradients, and acoustic noise
- Prepare complete labeling package including user manual and site planning information
- Perform biocompatibility testing for patient-contacting materials
- Generate clinical images demonstrating diagnostic quality
- Document software development and cybersecurity measures
- Establish quality assurance procedures
- Create emergency procedures and safety protocols
- Prepare detailed site planning guidelines including magnetic field plots
Key Considerations
Clinical testing
- Clinical images required to demonstrate diagnostic quality
- Radiologist attestation may be acceptable with representative subset of images
- Clinical studies may be needed for specific clinical indications
Non-clinical testing
- Signal-to-noise ratio measurements
- Geometric distortion assessment
- Image uniformity testing
- Slice thickness verification
- Spatial resolution demonstration
- Spectroscopy performance testing (if applicable)
Human Factors
- Peripheral nerve stimulation studies required for high dB/dt systems
- Assessment of operator interface and controls
- Emergency procedures validation
Software
- Basic documentation level typically required
- Cybersecurity documentation required for cyber devices
- Additional requirements for off-the-shelf software
Cybersecurity
- Required documentation under section 524B(b) of FD&C Act for cyber devices
- Network security considerations
- Wireless technology security if applicable
Labelling
- Detailed user manual requirements
- Site planning information
- Summary specification sheet
- RF coil specific labeling
- Safety warnings and contraindications
- Emergency procedures
- Quality assurance procedures
Biocompatibility
- Required for patient-contacting materials
- ISO 10993-1 evaluation needed
Safety
- Acoustic noise measurements
- RF energy deposition assessment
- Surface heating evaluation
- Gradient-induced electric fields testing
- Cryogen safety considerations
Other considerations
- Fixed parameter options implementation
- Electromagnetic compatibility testing
- Site planning requirements
- Quality assurance procedures
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
Related references and norms 📂
- 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
- NEMA MS 1-12: Various standards for MR measurement methods
- ISO 10993-1: Biological evaluation of medical devices
- ANSI/AAMI ES60601-1: Medical electrical equipment - General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2: Medical electrical equipment - Electromagnetic Disturbances
Original guidance
- Premarket Notification Requirements for Magnetic Resonance Diagnostic Devices
- HTML / PDF
- Issue date: 2023-10-10
- Last changed date: 2023-10-10
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, 510(k), Premarket, Radiological Health, Radiology
- ReguVirta ID: 1b31588f477010582f9f51b0d1fb678a