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.
Recommended Actions
- 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
- Implement specific labeling elements:
- Storage conditions
- Compatibility information
- Expiration date in correct format
- Device dimensions and specifications
- Develop clear instructions for:
- Device preparation
- Safe handling procedures
- Compatibility with other devices
- Troubleshooting guidance
- Include warnings about:
- Single use only
- Risks of coating damage
- Proper manipulation techniques
- Incompatible materials or solutions
- 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
- Storage and handling conditions
- Expiration date requirements
- Device compatibility information
- Troubleshooting guidance
Relevant Guidances
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms
- 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
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