Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products

Recommended Actions

1. Establish a robust documentation system for all required reports (product, supplemental, annual, and accidental radiation occurrence)
2. Implement and maintain a comprehensive testing program with proper record-keeping
3. Review and update all product labeling to ensure compliance with identification and certification requirements
4. Create a checklist for label requirements including manufacturer address, date format, and proper identification
5. Develop a system to track and submit reports according to required timelines
6. Conduct regular audits of testing programs and documentation to ensure ongoing compliance
7. Train relevant personnel on reporting requirements and testing procedures
8. Establish a process for immediate reporting of accidental radiation occurrences
9. Review and update any outdated references (DHEW or BRH) on existing documentation or labels

Key Considerations

Non-clinical testing

• Testing program must be adequate and complete
• Testing records must be maintained
• Testing deficiencies must be addressed

Labelling

• Certification label must be present
• Identification label must be present
• Date format must not be coded or abbreviated
• Manufacturer’s complete address must be included
• References to DHEW or BRH should be updated

Other considerations

• Product reports must be submitted as required
• Supplemental reports must be submitted as required
• Annual reports must be submitted as required
• Accidental radiation occurrence reports must be submitted as required
• For non-consumer products, month and year can be included in serial number

  Relevant Guidances

• Radiation Safety Requirements for Diagnostic X-Ray Systems and Components
• Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
• Diagnostic X-Ray Systems: Component Labeling, Assembly, and Safety Requirements
• X-Ray Equipment Performance Standards and Radiation Safety Requirements
• Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
• Safety Considerations for Hand-Held X-Ray Equipment: Radiation Protection and Testing Requirements

---

Original guidance

• Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products
• HTML
• Issue date: 2007-10-30
• Last changed date: 2020-03-24
• Status: FINAL
• Official FDA topics: Medical Devices, Radiation-Emitting Products, Postmarket
• ReguVirta summary file ID: 9618fc61717e0dd22e287da78b9ea082