Labeling Requirements for Surgical Staplers and Staples for Internal Use
This guidance applies to surgical staplers and staples for internal use, including manual and powered linear cutting staplers, transverse approximator non-cutting open staplers, and circular staplers used in open/endoscopic surgery. It covers devices under specific product codes: GAG (Stapler, Surgical), GDW (Staple, Implantable), NLL (Staple, Implantable, Reprocessed), and NAY (System, Surgical, Computer Controlled Instrument).
Recommended Actions
- Review current device labeling against guidance requirements
- Update labeling to include all required warnings, contraindications, and technical specifications
- Ensure package labels clearly display critical information for device selection
- Implement changes within 180 days of guidance publication for non-878.4740 devices
- Evaluate if labeling changes require new 510(k) submission
- Update reprocessing instructions if applicable
- Add clear visual indicators and diagrams where appropriate
- Include specific tissue compatibility information
- Document compatibility with other devices/materials
- Implement clear safety mechanism identification
Key Considerations
Labelling
- Must include specific contraindications regarding use on necrotic, friable, or altered integrity tissues
- Must include warnings about tissue thickness limits, avoiding obstructions, tissue damage, aorta use, blood vessel control
- Must provide clear instructions for proper device use and cartridge handling
- Must list compatible staples and key performance parameters
- Package labels must include critical technical characteristics for proper device selection
- Must include validated reprocessing instructions for reusable components
- Must specify expiration date/shelf life
Safety
- Must include safety mechanisms identification
- Must provide warnings about crossing staple lines
- Must include information about blood vessel control methods in case of failure
Other considerations
- Must specify technical characteristics like:
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Original guidance
- Labeling Requirements for Surgical Staplers and Staples for Internal Use
- HTML / PDF
- Issue date: 2021-10-08
- Last changed date: 2021-10-07
- Status: FINAL
- Official FDA topics: Medical Devices, Device & Drug Safety, Labeling, General & Plastic Surgery
- ReguVirta summary file ID: ed647d1593af1ece6e4b7e876df588ff
This post is licensed under CC BY 4.0 by the author.