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.
What You Need to Know? 👇
What is the deadline for submitting X-ray equipment assembly reports to FDA?
Assemblers must submit Form FD-2579 to CDRH, the purchaser, and applicable state authorities within 15 days of completing assembly. Reports received more than 30 days after completion are considered late and may trigger regulatory action.
What regulatory actions can FDA take against non-compliant X-ray equipment assemblers?
FDA can issue Notice of Noncompliance Letters, Warning Letters, and request civil penalties or injunctions. The escalation depends on violation severity and history, with civil penalties being the preferred action for repeat offenders.
How does FDA verify that X-ray assembly reports were filed late or not at all?
FDA establishes proof through records inspections at firms, review of FDA office records, CDRH computer files, purchaser interviews, and state record reviews to document non-compliance with reporting requirements.
What are the prerequisites for FDA to issue a Warning Letter to X-ray assemblers?
FDA must establish clear proof that Form FD-2579 was never filed or filed late, and must have previously sent at least one Notice of Noncompliance Letter with confirmed receipt evidence.
When can FDA request civil penalties against X-ray equipment assemblers?
Civil penalties may be requested when assemblers have failed to report or reported late at least twice, received written warnings twice within twelve months, and failed to respond or comply with Warning Letters.
Which FDA division handles regulatory actions against X-ray equipment assemblers?
The appropriate Division within the Office of Medical Devices and Radiological Health Operations (OMDRHO) handles these regulatory actions, including issuing compliance letters and requesting penalties from CDRH.
What You Need to Do 👇
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:
- First step: Notice of Noncompliance Letter
- Second step: Warning Letter
- Final step: Civil penalties and/or injunction for continued non-compliance
Relevant Guidances 🔗
- 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