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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.

  1. Conduct comprehensive performance testing according to recognized standards
  2. Develop detailed device description including all major components
  3. Implement and validate safety controls for RF energy, gradients, and acoustic noise
  4. Prepare complete labeling package including user manual and site planning information
  5. Perform biocompatibility testing for patient-contacting materials
  6. Generate clinical images demonstrating diagnostic quality
  7. Document software development and cybersecurity measures
  8. Establish quality assurance procedures
  9. Create emergency procedures and safety protocols
  10. 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

  • 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 summary file ID: 1b31588f477010582f9f51b0d1fb678a
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