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.
What You Need to Know? 👇
What are the key labeling requirements for intravascular devices with lubricious coatings according to FDA guidance?
The FDA recommends including coating identification, location, length, and purpose in device descriptions. Labeling must contain specific warnings about coating damage, preparation steps, compatibility information, and potential adverse events like embolism or stroke.
Which medical devices fall under the FDA’s lubricious coating guidance scope?
The guidance covers Class II and III intravascular devices including catheters, guidewires, balloon angioplasty catheters, delivery sheaths, stents, and embolization devices used in cerebrovascular, cardiovascular, and peripheral vascular procedures with hydrophilic or hydrophobic coatings.
What are the main safety concerns with lubricious coatings on medical devices?
Coating separation (peeling, flaking, shedding) can cause serious adverse events including pulmonary embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. The FDA has received reports requiring surgical intervention to remove coating fragments.
How should manufacturers handle device compatibility information in labeling?
Manufacturers must specify device dimensions, identify safe device combinations, and warn about tight fits that may cause coating damage. Size mismatches between devices can result in coating separation and adverse events during procedures.
What preparation steps should be included in labeling for coated devices?
Labeling should specify appropriate conditioning media, pre-conditioning duration, storage conditions, and practices to avoid (like wiping with dry gauze or using alcohol). Instructions must prevent coating damage that could compromise device safety.
When should manufacturers submit new 510(k) applications for coating-related labeling changes?
Manufacturers should refer to FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” when updating labeling for currently cleared devices. The FDA recommends incorporating these safety-based recommendations in future submissions.
What You Need to Do 👇
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