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.
Recommended Actions
- Implement a process to investigate and determine root cause of any defects or noncompliances discovered
- Establish clear documentation procedures for evidence of user abuse/improper maintenance when charging for corrections
- Develop reporting templates and procedures for FDA notifications
- Create a tracking system for defects/noncompliances and their resolutions
- Train staff on obligations regarding free-of-charge corrections versus chargeable repairs
- Maintain records of all notifications sent to FDA and communications with factory-based manufacturers
- 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
- 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
- Model and Serial Number Labeling Requirements for X-Ray System Components
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 summary file ID: a822470563b6117c7d90f8b6d2423dd8
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