Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
This guidance clarifies the radiation control regulations for diagnostic X-ray equipment, focusing on product identification, certification, noncompliances, defects, and key definitions. It provides interpretations of various sections of the Performance Standard for Diagnostic X-ray Equipment (21 CFR Subchapter J) published in 1972.
What You Need to Know? 👇
What are the key radiation control regulations for diagnostic X-ray equipment?
The FDA’s Performance Standard for Diagnostic X-Ray Equipment (21 CFR 1020.30-32) establishes requirements for certification, identification, leakage radiation limits, beam quality, field limitation, and safety features to protect patients and operators from unnecessary radiation exposure.
Who is responsible for defects in X-ray equipment after installation?
Manufacturers are generally responsible for defects or noncompliance. However, they may not be liable if they can prove the defect resulted from unauthorized modifications, improper replacement parts, unforeseeable abuse, or user error rather than manufacturing faults.
What constitutes “reassembly” of an X-ray system under FDA regulations?
Reassembly means installing a group of components (including upgraded parts) that were previously assembled and used as an X-ray system. This applies to used systems being prepared for resale, regardless of component certification status.
When does repairing a tube housing assembly require new certification?
Repairs to tube housing assemblies, including temporary removal of the insert, do not constitute manufacturing a new assembly and don’t require new certification. Only replacement of the tube insert in a previously certified housing would trigger recertification requirements.
Are burned-out X-ray tubes considered safety defects under FDA regulations?
No, burned-out X-ray tubes are not considered safety defects but normal repair items. Defects only apply when they relate to safety risks from electronic product radiation emission, not equipment failure that produces no radiation.
What documentation must manufacturers provide with initial reports to FDA?
Manufacturers must submit complete initial reports including user instructions and assembler manuals. Partial submissions are accepted temporarily, but complete documentation must follow as supplements and be included with equipment before commercial distribution.
What You Need to Do 👇
Recommended Actions
- Review and update quality control programs to ensure absolute compliance with numerical limits
- Establish procedures for:
- Proper documentation and reporting
- Defect investigation and correction
- Product identification and certification
- Develop comprehensive user and assembler instructions
- Implement proper labeling systems
- Create process to track and investigate potential defects or noncompliance
- Establish clear documentation of design features that maintain acceptable radiation levels over product lifetime
- Review and update testing procedures to ensure compliance with absolute limits
- Train staff on definitions and requirements for different equipment types
- Establish process for handling repairs vs new manufacture situations
- Create system to maintain records of all required documentation and certifications
Key Considerations
Non-clinical testing
- Numerical limits stated in the standard are to be treated as absolute limits
- Manufacturers must design testing and quality control programs to ensure limits are not exceeded
- Normal roundoff procedures are not allowed if they result in exceeding any limit
Labelling
- Warning labels must be placed appropriately on equipment
- Product identification and certification information must be included
- Instructions for users and assemblers must be provided
Safety
- Manufacturers are responsible for defects or noncompliance unless proven to be caused by user modification/abuse
- Defects related to radiation safety must be reported and corrected
- Normal wear resulting in excessive radiation is manufacturer’s responsibility
- Burned-out X-ray tubes are not considered safety defects if they produce no radiation
Other considerations
- Definitions provided for X-ray tables, tabletops and cradles
- Clarification on what constitutes “commerce” and “reassembly”
- Requirements for documentation and reporting
- Responsibilities of manufacturers vs users
Relevant Guidances đź”—
- 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
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
Related references and norms đź“‚
- 21 CFR 1020.30-32: Performance Standard for Diagnostic X-Ray Equipment