Labeling Requirements for Keratomes Used in LASIK Surgery
This guidance clarifies FDA's position on labeling keratomes for LASIK indication, providing requirements for manufacturers to either immediately label their devices for LASIK or submit a new 510(k) based on specific criteria.
Recommended Actions
- Review existing 510(k) documentation to determine if it contains all required specifications and testing information
- If documentation is complete:
- Update device labeling to include LASIK indication
- Consider submitting new 510(k) to update recorded indication statement
- If documentation is incomplete:
- Prepare new 510(k) submission including all required elements
- Conduct necessary testing to validate flap specifications
- Document methods and components for flap creation
- Develop comprehensive instructions for flap creation
- Ensure compliance with least burdensome approach principles when preparing submissions
- Maintain records of all specification validations and testing results
Key Considerations
Non-clinical testing
- Validation testing protocols and results for flap specifications
- Testing to demonstrate accuracy and variability of the corneal flap produced
Labelling
- Must include specifications for:
- Type of hinge or flap (nasal or superior)
- Thickness(s) of cut
- Flap diameter(s)
- Hinge width(s)
- Must include instructions for creating a flap
Safety
- Description of methods and components for variable hinge, diameter, or thickness production
- Description of blade halting mechanism for hinge or flap creation
Other considerations
- Previously cleared devices can be immediately labeled for LASIK if their 510(k) contained all required information
- New 510(k) submission required to change the recorded indication statement
- If original 510(k) did not contain required information, new submission necessary before LASIK labeling
Relevant Guidances
- Keratomes and Replacement Keratome Blades for Corneal Surgery
- Patient Labeling for Laser-Assisted In Situ Keratomileusis (LASIK) Devices (Draft)
Related references and norms
- 21 CFR 807.87: Requirements for 510(k) submission
Original guidance
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