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.
Recommended Actions
- Implement quality control procedures to ensure proper assembly according to manufacturer instructions
- Establish documentation system for assembly and installation processes
- Create checklist for critical safety components verification
- Develop training program for proper assembly procedures
- Implement regular internal audits of assembly processes
- Establish procedure for prompt response to FDA notifications
- Maintain records of all installations and field test results
- Create corrective action protocol for addressing identified noncompliances
- Establish communication protocol with FDA for compliance matters
- 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
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- Enforcement Policy for X-Ray Assembly Report Filing Requirements
- Correction and Reporting Requirements for Diagnostic X-Ray Equipment Defects and Noncompliances
- Performance Standards for Diagnostic X-Ray Systems and Major Components
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 summary file ID: 68097f0a460491f18fb1c786ef774328
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