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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.

  1. Establish process to verify component certification and compatibility before installation
  2. Implement testing procedures according to manufacturer instructions
  3. Create checklist for proper labeling requirements
  4. Develop system for timely filing of Form FDA 2579 within 15 days of installation
  5. Establish record keeping system for maintaining documentation for 5 years
  6. Create procedure for reporting accidental radiation occurrences
  7. Develop training program for assemblers on requirements and responsibilities
  8. Establish process to obtain and maintain manufacturer instructions for all components
  9. Create verification process for power specifications before connection
  10. 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

  • 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

  • Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
  • HTML / PDF
  • Issue date: 2023-02-21
  • Last changed date: 2023-02-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: 02b4d644b7203434727793085d6bd77d
This post is licensed under CC BY 4.0 by the author.