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.
What You Need to Know? 👇
What are the key responsibilities of assemblers under FDA diagnostic X-ray equipment regulations?
Assemblers must install certified components according to manufacturer instructions, file Form FDA 2579 within 15 days, ensure compatibility between components, and report accidental radiation occurrences. They’re legally responsible for proper assembly, testing, and compliance with Performance Standards.
When is a Report of Assembly (Form FDA 2579) required for X-ray equipment installations?
Form FDA 2579 is required when installing certified components into human-use diagnostic X-ray systems, except for certified accessory components, repaired components returning to original systems, temporary installations with proper labeling, and equivalent tube housing assembly replacements.
What constitutes “compatibility” between diagnostic X-ray components under FDA regulations?
Compatibility means components can work together to meet Performance Standards when assembled per manufacturer instructions. Manufacturers must specify compatibility through model designations or physical characteristics. Operational compatibility alone is insufficient for certified component installations without manufacturer-specified compatibility statements.
Are there exceptions to filing assembly reports for temporary or loaner X-ray components?
Yes, temporary components installed during repairs don’t require assembly reports if properly labeled with specific FDA-required information including assembler signature, company details, and installation date. However, permanent replacement of temporary components requires new assembly reports.
What documentation must manufacturers provide to assemblers for certified X-ray components?
Manufacturers must provide assembly, installation, adjustment, and testing instructions adequate to ensure Performance Standards compliance. They must also specify compatible components through model designations or physical characteristics, plus user manuals with technical specifications and maintenance schedules.
How should assemblers handle situations where manufacturer instructions are inadequate or unclear?
Assemblers should contact manufacturers for clarification before proceeding and document issues in the assembly report’s comments section. Installation should be postponed if unclear instructions could result in non-compliance with Performance Standards, and assemblers may refuse connections if required power specifications aren’t met.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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