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.
What You Need to Know? 👇
What are the key requirements for keratome manufacturers to obtain LASIK labeling according to FDA guidance?
Manufacturers must provide flap specifications (hinge type, thickness, diameter, width, accuracy), validation protocols with results, descriptions of flap creation methods including variable components and blade stopping mechanisms, and detailed instructions for creating corneal flaps.
Can keratome manufacturers immediately label their devices for LASIK if they meet FDA criteria?
Yes, if their previously cleared 510(k) submission contained the four required criteria (flap specifications, validation protocols, creation methods, and instructions), manufacturers can immediately label their device for LASIK without submitting a new 510(k).
What’s the difference between device labeling and recorded indication statements for LASIK keratomes?
Device labeling can be changed immediately if criteria are met, but the recorded indication statement on FDA’s website remains unchanged. To update the recorded statement, manufacturers must submit a new 510(k) with the revised indication statement.
When did FDA change its position on LASIK claims for keratomes?
FDA reexamined its 1996 position and issued this final guidance in 2001. Initially, FDA didn’t clear LASIK requests because it was considered off-label use, but since LASIK became an approved indication for refractive lasers, keratomes could also claim this indication.
What must manufacturers do if their original 510(k) didn’t include the required LASIK criteria?
They cannot label their keratome for LASIK and must submit a new 510(k) submission addressing all four required criteria (flap specifications, validation protocols, creation methods, and instructions) before receiving FDA clearance for LASIK labeling.
How does the least burdensome approach apply to LASIK keratome submissions?
FDA considered the least burdensome approach when developing this guidance. If manufacturers believe there’s a less burdensome way to address the requirements, they should follow procedures outlined in FDA’s “A Suggested Approach to Resolving Least Burdensome Issues” document.
What You Need to Do 👇
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