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.
Recommended Actions
- Determine if your facility qualifies as a primary X-ray component assembler with reloading activities
- If qualified as above, verify exemption status from registration, listing, and biennial inspections
- Implement system for maintaining required records:
- Complaint files
- Injury reports
- Failure analysis records
- Ensure compliance with:
- Electronic Product Radiation Control requirements
- Diagnostic X-ray Standard
- Good Manufacturing Practices
- Establish process for making records available for FDA inspection when requested
- 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
- Firms whose primary activity is X-ray component assembly are exempt from:
- Establishment registration
- Device listing
- Biennial inspection requirements
- Must maintain:
- Complaint files
- Injury reports
- Failure analysis records
- Records must be available for agency inspection
- Inspections will be conducted on a “for cause” basis
- Original equipment manufacturers remain subject to all registration, listing, and inspection requirements
Relevant Guidances
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
Related references and norms
- 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
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