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Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems

This guidance clarifies the requirements for manufacturers of diagnostic x-ray systems regarding the disclosure of specifications for assembly, installation, adjustment, and testing (AIAT) information to assemblers. It explains the scope of information disclosure obligations, cost considerations, and software-related aspects to ensure compliance with federal performance standards.

  1. Establish a process to provide complete AIAT documentation for each certified component
  2. Develop clear cost calculation methodology based on production and distribution expenses
  3. Create separate documentation packages for AIAT information if bundled with proprietary software
  4. Implement verification procedures to ensure AIAT information is adequate for compliance
  5. Establish cooperation protocols between manufacturers and assemblers
  6. Create testing procedures documentation that aligns with federal performance standards
  7. Maintain records of AIAT information requests and distributions
  8. Review and update AIAT documentation when component modifications occur
  9. Ensure accessibility of AIAT information in appropriate formats (printed/digital)
  10. Train relevant staff on AIAT disclosure requirements and procedures

Key Considerations

Non-clinical testing

  • Testing procedures must be provided to verify proper operation and performance of x-ray system
  • Test methods must be included to verify compliance with performance standards
  • Documentation for radiation leakage testing and beam alignment procedures must be provided

Software

  • AIAT software can be bundled with proprietary software but must be provided at cost
  • Manufacturers can provide AIAT software separately or as printed materials
  • Software that doesn’t relate to AIAT activities is not subject to disclosure

Safety

  • Assembly and installation procedures must ensure compliance with radiation safety standards
  • Information must be provided to prevent unnecessary x-ray exposure
  • Safety and technical information must be disclosed to users

Other considerations

  • 21 CFR 1020.30: Performance standards for diagnostic x-ray systems and their major components
  • 21 CFR 1020.31: Radiographic equipment performance requirements
  • 21 CFR 1020.33: Computed tomography equipment performance requirements

Original guidance

  • Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
  • HTML / PDF
  • Issue date: 2003-09-04
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Postmarket
  • ReguVirta summary file ID: 185fd31cb49d404dedc1455aa474b642
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