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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.

  1. Implement a tracking system to ensure timely submission of Form FD 2579 within 15 days of assembly completion
  2. Maintain comprehensive records of all assembly reports submitted
  3. Establish a process to document proof of submission to all required parties (CDRH, purchaser, and State)
  4. Create a response procedure for any Notice of Noncompliance or Warning Letter received
  5. Develop a compliance monitoring system to prevent repeated violations
  6. Train personnel on the importance of timely report submission and consequences of non-compliance
  7. Establish a quality control process to verify report completion and submission within required timeframes

Key Considerations

Other considerations

  • 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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