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Distinguishing Between Medical Device Recalls and Device Enhancements

This guidance applies to medical devices regulated by CDRH to help distinguish between device recalls and device enhancements. It excludes radiation-emitting electronic products, risk management methodologies, and does not address whether new premarket submissions are required.

  1. Establish a process to evaluate device changes and determine if they constitute a recall or enhancement
  2. For potential recalls, assess:
    • If the device is currently marketed
    • If there are violations of FDA regulations
    • If specifications are not being met
    • If labeling is false or misleading
    • If there are risks to health
  3. For recalls:
    • Submit 806 report within 10 working days if health risk exists
    • Maintain required documentation
    • Implement correction or removal actions
  4. For enhancements:
    • Document rationale for enhancement classification
    • Maintain records of changes
    • Evaluate need for new premarket submissions
  5. Implement a tracking system for both recalls and enhancements to ensure proper documentation and follow-up
  6. Train relevant personnel on distinguishing between recalls and enhancements

Key Considerations

Human Factors

  • Changes related to ergonomics or usability that affect device safety or performance may constitute a recall if they are linked to violations

Software

  • Software changes to address computation errors or failures to perform as represented constitute a recall
  • Software updates for enhancement purposes without violations are not recalls

Labelling

  • Changes to address false or misleading labeling constitute a recall
  • Changes to address inadequate directions for use constitute a recall
  • Addition of new warnings to non-violative devices is considered enhancement

Safety

  • Changes to address failure to meet specifications or perform as represented constitute a recall
  • Increase in failure rates or new failure modes may indicate need for recall
  • Changes to improve non-violative device safety are considered enhancements

Other considerations

  • 21 CFR Part 7: Enforcement Policy
  • 21 CFR Part 806: Medical Device Reports of Corrections and Removals
  • 21 CFR Part 820: Quality System Regulation

Original guidance

  • Distinguishing Between Medical Device Recalls and Device Enhancements
  • HTML / PDF
  • Issue date: 2014-10-15
  • Last changed date: 2019-02-26
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket
  • ReguVirta summary file ID: ef660369b500ce6da2d0255f43c6ca8e
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