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.
Recommended Actions
- Establish a process to provide complete AIAT documentation for each certified component
- Develop clear cost calculation methodology based on production and distribution expenses
- Create separate documentation packages for AIAT information if bundled with proprietary software
- Implement verification procedures to ensure AIAT information is adequate for compliance
- Establish cooperation protocols between manufacturers and assemblers
- Create testing procedures documentation that aligns with federal performance standards
- Maintain records of AIAT information requests and distributions
- Review and update AIAT documentation when component modifications occur
- Ensure accessibility of AIAT information in appropriate formats (printed/digital)
- 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
- AIAT information must be provided for each certified component
- Cost recovery limited to production and distribution expenses
- Manufacturers and assemblers share legal responsibility for compliance
- Information must be adequate and complete for proper assembly and installation
Relevant Guidances
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- Model and Serial Number Labeling Requirements for X-Ray System Components
- Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances
- Regulatory Actions and Civil Penalties for Non-Compliant Diagnostic X-ray Equipment Assemblers
- Enforcement Policy for X-Ray Assembly Report Filing Requirements
Related references and norms
- 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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