Enforcement Policy for X-Ray Assembly Report Filing Requirements
This guidance outlines regulatory actions against assemblers of diagnostic X-ray systems who fail to comply with the requirement to file reports of assembly (Form FD 2579) as per 21 CFR 1020.30(d). The reports must be submitted to CDRH, purchaser, and applicable State within 15 days of assembly completion.
Recommended Actions
- Implement a tracking system to ensure timely submission of Form FD 2579 within 15 days of assembly completion
- Maintain comprehensive records of all assembly reports submitted
- Establish a process to document proof of submission to all required parties (CDRH, purchaser, and State)
- Create a response procedure for any Notice of Noncompliance or Warning Letter received
- Develop a compliance monitoring system to prevent repeated violations
- Train personnel on the importance of timely report submission and consequences of non-compliance
- Establish a quality control process to verify report completion and submission within required timeframes
Key Considerations
Other considerations
- Reports must be filed within 15 days following assembly completion
- Reports received more than 30 days after assembly completion are considered late
- Clear proof of non-filing or late filing must be established through:
- Records inspection at the firm
- Review of FDA office records
- Review of CDRH computer files
- Purchaser interviews
- State records review
- Progressive enforcement approach:
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
Related references and norms
- 21 CFR 1020.30(d): Performance standards for diagnostic X-ray systems and their major components
Original guidance
- Enforcement Policy for X-Ray Assembly Report Filing Requirements
- HTML / PDF
- Issue date: 1995-03-01
- Last changed date: 2018-12-01
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology, Investigation & Enforcement
- ReguVirta summary file ID: d9bd3823de48ec02e01cc094bccf325c
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