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Determining and Managing Off-Label Use Concerns in 510k Submissions

This guidance outlines CDRH staff procedures for determining the intended use of devices in 510(k) submissions, focusing on how to handle situations where there is a reasonable likelihood of off-label use that could cause harm.

  1. Review all proposed labeling materials thoroughly to clearly define intended use
  2. Document any potential off-label uses identified during review
  3. Assess likelihood of off-label use and potential harm
  4. If off-label use concerns exist:
    • Escalate to senior division management
    • Contact Premarket Notification Section Chief
    • Prepare for possible consultation with Office Director
  5. Consider device modifications if off-label use concerns are raised
  6. Implement any required labeling limitations exactly as specified in SE letter
  7. Submit new 510(k) for any modifications to imposed labeling limitations
  8. Maintain documentation of all decisions and communications regarding intended use determination

Key Considerations

Labelling

  • Intended use must be determined by the proposed labeling for the product
  • Labeling includes the actual label and any accompanying information such as directions for use and promotional materials
  • When limitations are imposed due to off-label use concerns, they must be included in Precautions, Warnings, Contraindications, or other appropriate sections
  • Any modification to labeling limitations requires a new 510(k) submission

Safety

  • Must evaluate if there is a reasonable likelihood of off-label use that could cause harm
  • If off-label use concerns exist, specific limitations may be imposed through an “SE with limitations” letter

Other considerations

  • 21 CFR 807.87(e): Requirements for 510(k) submission content regarding labeling

Original guidance

  • Determining and Managing Off-Label Use Concerns in 510k Submissions
  • HTML / PDF
  • Issue date: 2002-12-02
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 04e60bf541cc2cca86e8100c7f546f65
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