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.
What You Need to Know? 👇
What are the AIAT information disclosure requirements for diagnostic X-ray system manufacturers?
Manufacturers must provide Assembly, Installation, Adjustment, and Testing (AIAT) information to assemblers upon request. This includes instructions for proper assembly, installation procedures, adjustment protocols, and testing methods to ensure compliance with federal performance standards for radiation safety.
How should manufacturers handle software bundling when providing AIAT information?
Manufacturers can bundle AIAT software with proprietary software but must provide the entire bundle at AIAT cost only. Alternatively, they can separate the software domains or provide printed materials to ensure adequate, complete, and useable instructional materials are available.
What costs can manufacturers recover when providing AIAT documentation?
Manufacturers may only recover actual production costs including paper, labor, copying, computer disks, and packaging materials. The pricing should not generate profit or loss and must reflect reasonable factors for producing each additional package or unit of instructions.
Does delivering a fully assembled X-ray system eliminate AIAT disclosure obligations?
No, delivering fully assembled systems does not relieve manufacturers of their 21 CFR 1020.30(g) obligations. AIAT information must still be provided for each certified component used in the controlled production of X-rays, regardless of assembly status at delivery.
What is the difference between assembly and installation in AIAT requirements?
Assembly involves fitting together parts or pieces of components, while installation includes setting up for use by verifying proper assembly and adjustments to ensure compliance with federal performance specifications. These terms should not be used interchangeably.
Who bears legal responsibility for compliance with X-ray system performance standards?
Both manufacturers and assemblers bear legal responsibility for their respective roles. Manufacturers certify components meet standards when properly assembled per instructions, while assemblers certify systems were assembled, installed, adjusted, and tested according to manufacturer’s instructions.
What You Need to Do 👇
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