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Labeling for Intravascular Devices with Lubricious Coatings

This guidance provides labeling recommendations for Class II and Class III intravascular devices with lubricious coatings used in neuro-, coronary, and peripheral vasculature. It covers devices such as intravascular catheters, wires, and delivery systems with hydrophilic and/or hydrophobic coatings.

  1. Review and update current device labeling to include:
    • Clear identification of coating presence and characteristics
    • Comprehensive warnings and precautions
    • Detailed preparation and handling instructions
    • List of potential adverse events
  2. Implement specific labeling elements:
    • Storage conditions
    • Compatibility information
    • Expiration date in correct format
    • Device dimensions and specifications
  3. Develop clear instructions for:
    • Device preparation
    • Safe handling procedures
    • Compatibility with other devices
    • Troubleshooting guidance
  4. Include warnings about:
    • Single use only
    • Risks of coating damage
    • Proper manipulation techniques
    • Incompatible materials or solutions
  5. Document and justify any deviations from the guidance recommendations in premarket submissions

Key Considerations

Labeling

  • Device description must identify coating presence, type, location, length and purpose
  • Specify compatible ancillary devices and dimensions
  • Include specific indications for use and vascular regions
  • Provide warnings about coating damage risks
  • Include preparation steps and handling instructions
  • List potential adverse events related to coating loss
  • Specify storage conditions and expiration date
  • Detail device compatibility information

Safety

  • Warning against reuse or re-sterilization
  • Caution when manipulating through sharp edges or calcified vessels
  • Instructions for safe device combinations
  • Specification of appropriate conditioning media
  • Practices to avoid during preparation and use

Other considerations

  • 21 CFR Part 801.109: Prescription devices labeling requirements
  • 21 CFR 801.18: Format of dates provided on labeling

Original guidance

  • Labeling for Intravascular Devices with Lubricious Coatings
  • HTML / PDF
  • Issue date: 2019-10-10
  • Last changed date: 2019-10-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Cardiovascular, Premarket Approval (PMA), 510(k), Labeling, Neurological
  • ReguVirta summary file ID: a83c5f920333f983916e83d62f238994
This post is licensed under CC BY 4.0 by the author.