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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.

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the most common assembler violations in diagnostic X-ray equipment?

The most frequent violations include collimation problems causing improper X-ray field sizing, interlock misassemblies allowing X-ray production without proper barriers, miscalibrated fluoroscopic controls exceeding exposure limits, and inadequate collimator light illuminance due to lamp voltage misadjustment.

When should civil penalties be considered for X-ray equipment assembler violations?

Civil penalties are recommended when test results show Class A or B noncompliances within one year of installation, assemblers have received prior written warnings, notices were issued within 45 days of testing, and at least two installations demonstrate violations after warning notification.

What is the primary enforcement mechanism for X-ray assembler performance standard violations?

The FDA primarily uses civil penalties as the enforcement mechanism for assembler violations. Injunctions are only considered when civil penalties prove ineffective, there’s evidence of gross negligence, willful violations, or when injuries result from the violations.

How soon after installation must X-ray equipment testing occur for enforcement actions?

Testing must be performed as soon as possible after assembly but no more than one year after installation. This timeframe minimizes assembler claims that noncompliance resulted from normal wear, improper maintenance, or inadequate repair rather than assembly errors.

What documentation is required before recommending civil penalties against X-ray assemblers?

Required documentation includes written warnings to assemblers and headquarters officials about past violations, notices of adverse findings issued within 45 days of field tests, and evidence of at least two noncompliant installations assembled within one year after warning notification.

What types of noncompliances are classified under the diagnostic X-ray field testing program?

Field test results are classified as either Class A or Class B noncompliances as described in FDA Compliance Program 7386.003 for Field Compliance Testing of Diagnostic Medical X-ray Equipment, though specific classification criteria aren’t detailed in this guidance document.

What You Need to Do 👇

  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

  • Written notification to assembler and headquarters officials of violations
  • Documentation of at least two different noncompliant installations after warning
  • Civil penalties as primary enforcement mechanism
  • Injunction considered for continuing gross negligence or willful violations

Relevant Guidances 🔗

Related references and norms 📂

  • 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 ID: 68097f0a460491f18fb1c786ef774328
FDA guidance, Final
Medical Devices Radiation-Emitting Products Investigation & Enforcement
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