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Regulatory Actions and Civil Penalties for Non-Compliant Diagnostic X-ray Equipment Assemblers

This guidance outlines regulatory actions against assemblers of diagnostic X-ray equipment who fail to comply with the Diagnostic X-ray Standard, focusing on enforcement mechanisms and criteria for civil penalties.

  1. Implement quality control procedures to ensure proper assembly according to manufacturer instructions
  2. Establish documentation system for assembly and installation processes
  3. Create checklist for critical safety components verification
  4. Develop training program for proper assembly procedures
  5. Implement regular internal audits of assembly processes
  6. Establish procedure for prompt response to FDA notifications
  7. Maintain records of all installations and field test results
  8. Create corrective action protocol for addressing identified noncompliances
  9. Establish communication protocol with FDA for compliance matters
  10. Implement verification steps for critical safety features (collimation, interlocks, exposure rates, illuminance)

Key Considerations

Non-clinical testing

  • Field testing results must be obtained within one year of installation
  • Test results must be classified as either Class A or Class B noncompliances
  • Notices of adverse findings must be issued within 45 days of field test (60 days for State tests)

Safety

  • Proper collimation in radiographic, fluoroscopic, and spot film modes
  • Correct interlock assembly for x-ray beam protection
  • Appropriate entrance exposure rates through proper calibration
  • Adequate illuminance from light localizer

Other considerations

  • 21 CFR 1003.11: Notification requirements for manufacturers of electronic products
  • 21 U.S.C. 360ll(e): Notification of defects in and repair or replacement of electronic products

Original guidance

  • Regulatory Actions and Civil Penalties for Non-Compliant Diagnostic X-ray Equipment Assemblers
  • 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: 68097f0a460491f18fb1c786ef774328
This post is licensed under CC BY 4.0 by the author.