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Voluntary Malfunction Summary Reporting Program for Medical Devices

This guidance explains the Voluntary Malfunction Summary Reporting (VMSR) Program which allows manufacturers to report certain device malfunctions in summary form quarterly instead of individual 30-day reports. It applies to manufacturers of devices within eligible product codes and aims to streamline malfunction reporting while maintaining FDA's ability to monitor device safety.

  1. Verify product code eligibility for VMSR Program participation
  2. Update MDR procedures to include:
    • Process for identifying when individual vs summary reporting is required
    • Quarterly reporting schedule and format requirements
    • Supplemental reporting procedures
  3. Implement system to track and categorize malfunction events by:
    • Brand name
    • Device model
    • Problem codes
    • New vs previously reported malfunction types
  4. Train relevant personnel on:
    • VMSR Program requirements and conditions
    • Form FDA 3500A completion for summary reports
    • Individual reporting triggers
    • Supplemental reporting requirements
  5. Establish process to monitor FDA communications regarding:
    • Product code eligibility changes
    • Requests for individual reporting
    • Program updates
  6. Maintain documentation of:
    • Decision to participate in VMSR Program
    • All summary and individual reports submitted
    • Compliance with program conditions

Key Considerations

Safety

  • Individual reporting is required for:
    • Reportable deaths and serious injuries
    • Events associated with 5-day reports
    • Events subject to certain device recalls
    • When FDA determines individual reporting is needed for public health issues
    • New types of malfunctions not previously reported
  • Summary reports must be submitted quarterly according to defined schedule
  • Each summary report must include specific information like device identifier, brand name, model number, description of events, etc.

Other considerations

  • ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes

Original guidance

  • Voluntary Malfunction Summary Reporting Program for Medical Devices
  • HTML / PDF
  • Issue date: 2024-08-29
  • Last changed date: 2024-08-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Biologics
  • ReguVirta summary file ID: 5a6f51abfd956a8b2648aa7fca8a0c9c
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