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Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment

This guidance clarifies the radiation control regulations for diagnostic X-ray equipment, focusing on product identification, certification, noncompliances, defects, and key definitions. It provides interpretations of various sections of the Performance Standard for Diagnostic X-ray Equipment (21 CFR Subchapter J) published in 1972.

  1. Review and update quality control programs to ensure absolute compliance with numerical limits
  2. Establish procedures for:
    • Proper documentation and reporting
    • Defect investigation and correction
    • Product identification and certification
  3. Develop comprehensive user and assembler instructions
  4. Implement proper labeling systems
  5. Create process to track and investigate potential defects or noncompliance
  6. Establish clear documentation of design features that maintain acceptable radiation levels over product lifetime
  7. Review and update testing procedures to ensure compliance with absolute limits
  8. Train staff on definitions and requirements for different equipment types
  9. Establish process for handling repairs vs new manufacture situations
  10. Create system to maintain records of all required documentation and certifications

Key Considerations

Non-clinical testing

  • Numerical limits stated in the standard are to be treated as absolute limits
  • Manufacturers must design testing and quality control programs to ensure limits are not exceeded
  • Normal roundoff procedures are not allowed if they result in exceeding any limit

Labelling

  • Warning labels must be placed appropriately on equipment
  • Product identification and certification information must be included
  • Instructions for users and assemblers must be provided

Safety

  • Manufacturers are responsible for defects or noncompliance unless proven to be caused by user modification/abuse
  • Defects related to radiation safety must be reported and corrected
  • Normal wear resulting in excessive radiation is manufacturer’s responsibility
  • Burned-out X-ray tubes are not considered safety defects if they produce no radiation

Other considerations

  • 21 CFR 1020.30-32: Performance Standard for Diagnostic X-Ray Equipment

Original guidance

  • Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
  • HTML / PDF
  • Issue date: 1989-03-01
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology
  • ReguVirta summary file ID: 4b50bfcc177c59141b393474b71c93bd
This post is licensed under CC BY 4.0 by the author.