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Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances

This guidance outlines the obligations of factory-based manufacturers and assemblers of diagnostic X-ray equipment regarding radiation safety defects and noncompliances with performance standards, including reporting requirements and correction responsibilities.

  1. Implement a process to investigate and determine root cause of any defects or noncompliances discovered
  2. Establish clear documentation procedures for evidence of user abuse/improper maintenance when charging for corrections
  3. Develop reporting templates and procedures for FDA notifications
  4. Create a tracking system for defects/noncompliances and their resolutions
  5. Train staff on obligations regarding free-of-charge corrections versus chargeable repairs
  6. Maintain records of all notifications sent to FDA and communications with factory-based manufacturers
  7. Set up a quality system to ensure compliance with reporting requirements even when immediate corrections are made

Key Considerations

Safety

  • Manufacturers must correct defective or noncompliant diagnostic x-ray equipment at no cost to the owner
  • Assemblers must determine the cause of any noncompliance or defect discovered during repair or installation
  • Corrections must be made based on the cause of the defect:
    • If caused by assembly/installation: Assembler must correct at no charge
    • If caused by factory manufacture: Factory-based manufacturer must correct at no charge
    • If caused by user abuse/improper maintenance: Correction can be charged to owner with documented evidence

Other considerations

  • 21 CFR 1003: Notification of Defects or Failure to Comply
  • 21 CFR 1004: Repurchase, Repairs, or Replacement of Electronic Products

Original guidance

  • Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances
  • HTML
  • Issue date: 1995-02-28
  • Last changed date: 2018-12-01
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology, Investigation & Enforcement
  • ReguVirta summary file ID: a822470563b6117c7d90f8b6d2423dd8
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