Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
This guidance document outlines the responsibilities and requirements for assemblers of diagnostic X-ray equipment under the Federal Performance Standards. It covers the assembly, installation, and reporting requirements for certified diagnostic X-ray components and systems used on human patients.
Recommended Actions
- Establish process to verify component certification and compatibility before installation
- Implement testing procedures according to manufacturer instructions
- Create checklist for proper labeling requirements
- Develop system for timely filing of Form FDA 2579 within 15 days of installation
- Establish record keeping system for maintaining documentation for 5 years
- Create procedure for reporting accidental radiation occurrences
- Develop training program for assemblers on requirements and responsibilities
- Establish process to obtain and maintain manufacturer instructions for all components
- Create verification process for power specifications before connection
- Implement system to track temporary installations and their proper labeling
Key Considerations
Non-clinical testing
- Assemblers must test certified components according to manufacturer’s instructions
- Testing must verify system compliance with Performance Standards
- Final testing at user location is considered the final step in manufacturing
Labelling
- Components must have certification and identification labels with manufacturer details
- Temporary components must be clearly labeled as temporarily installed
- Labels must include date and place of manufacture, model designation, and serial number
Safety
- Assemblers must ensure compatibility between components
- Power specifications must be met before connection
- Accidental radiation occurrences must be reported
- Modifications must not adversely affect compliance with Performance Standards
Other considerations
- Report of Assembly (Form FDA 2579) must be filed within 15 days of installation
- Records must be maintained for at least 5 years
- Only certified components can be installed with other certified components
- Temporary installations have specific labeling and reporting requirements
- Compatibility between components must be verified
Relevant Guidances
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- 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
- Performance Standards for Diagnostic X-Ray Systems and Major Components
Related references and norms
- 21 CFR Part 1020: Performance Standards for Ionizing Radiation Emitting Products
- 21 CFR Part 1000: General
- 21 CFR Part 1002: Records and Reports
- 21 CFR Part 1010: Performance Standards for Electronic Products: General
Original guidance
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