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X-ray Tube Housing Assembly Reloading Facilities: Registration, Listing and Inspection Requirements

This guidance clarifies the regulatory requirements for facilities that reload X-ray tube housing assemblies, specifically addressing their status regarding medical device establishment registration, device listing, and biennial inspection requirements.

  1. Determine if your facility qualifies as a primary X-ray component assembler with reloading activities
  2. If qualified as above, verify exemption status from registration, listing, and biennial inspections
  3. Implement system for maintaining required records:
    • Complaint files
    • Injury reports
    • Failure analysis records
  4. Ensure compliance with:
    • Electronic Product Radiation Control requirements
    • Diagnostic X-ray Standard
    • Good Manufacturing Practices
  5. Establish process for making records available for FDA inspection when requested
  6. If you are an original equipment manufacturer, maintain full compliance with all registration, listing, and inspection requirements

Key Considerations

Safety

  • Must comply with Chapter V, Subchapter C - Electronic Product Radiation Control requirements
  • Must comply with Diagnostic X-ray Standard
  • Must comply with Good Manufacturing Practices requirements

Other considerations

  • No specific norms or standards are referenced in this guidance

Original guidance

  • X-ray Tube Housing Assembly Reloading Facilities: Registration, Listing and Inspection Requirements
  • HTML
  • Issue date: 2005-02-28
  • Last changed date: 2018-12-01
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Investigation & Enforcement
  • ReguVirta summary file ID: ee3316580d289ec409b4a140ba13ca24
This post is licensed under CC BY 4.0 by the author.