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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.

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the reporting obligations for assemblers who discover defects in diagnostic X-ray equipment?

Assemblers must determine the cause of defects, perform corrective actions, and notify FDA according to 21 CFR 1003 and 1004. The specific reporting requirements depend on whether the defect was caused by improper assembly, factory manufacturing issues, or user abuse.

Who is responsible for covering the costs of correcting radiation safety defects in X-ray systems?

Manufacturers (including assemblers) must correct defects at no cost to the owner when caused by improper assembly, installation, or factory manufacturing issues. Owners may only be charged when defects result from documented user abuse, improper maintenance, or unauthorized repairs.

What penalties can manufacturers face for failing to report X-ray equipment defects to FDA?

Failure to correct or notify FDA of defects or noncompliances with performance standards is a violation of federal law, subject to civil penalties of up to $1,000 per offense under the Electronic Product Radiation Control provisions.

When must factory-based manufacturers be notified about X-ray equipment defects?

Factory-based manufacturers must be notified when assemblers determine that noncompliance or defects were caused in any way by the manufacturer. The manufacturer must then report all manufacturer-caused noncompliances and defects to FDA Headquarters (CDRH).

Does immediate correction of X-ray equipment defects exempt manufacturers from FDA reporting requirements?

No, immediate correction of defects or noncompliances by manufacturers or assemblers at the time of discovery does not exempt them from the 21 CFR 1003 reporting requirements to FDA.

What documentation is required before charging owners for X-ray equipment defect corrections?

Assemblers may only charge owners for corrections when they have obtained documented evidence of user abuse, lack of proper maintenance, or improper repair. Without such documentation, corrections must be provided at no cost to the owner.

What You Need to Do 👇

  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

  • Mandatory reporting requirements to FDA:
    • Assemblers must notify nearest FDA office for assembly-related defects
    • Assemblers must notify FDA and manufacturer for factory-related defects
    • Factory-based manufacturers must report all manufacturer-caused issues to FDA/CDRH
  • Civil penalty of up to $1000 per offense for failure to correct or notify FDA
  • Immediate correction does not exempt from reporting requirements

Relevant Guidances 🔗

Related references and norms 📂

  • 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 ID: a822470563b6117c7d90f8b6d2423dd8
FDA guidance, Final
Medical Devices Radiation-Emitting Products Radiology Investigation & Enforcement
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