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Patient Labeling for Laser-Assisted In Situ Keratomileusis (LASIK) Devices (DRAFT)

This guidance provides recommendations for content and formatting of patient labeling information for LASIK devices, including a patient decision checklist. It applies to all refractive lasers with LASIK indications for use (FDA product code LZS). The guidance aims to ensure that both physicians and patients receive and understand information about the benefits and risks of LASIK devices.

This is a draft guidance. Not for implementation.

  1. Develop comprehensive patient labeling following the recommended format and content
  2. Create clear visual aids and diagrams to explain procedures and symptoms
  3. Develop patient decision checklist with acknowledgment sections
  4. Conduct usability testing with representative users
  5. Ensure translation of medical terms into lay language
  6. Include all required risk information with appropriate prominence
  7. Develop plan to ensure adequate patient information delivery
  8. Create process for documenting patient and physician acknowledgment
  9. Establish system for providing copies of decision checklist to patients
  10. Update labeling through appropriate FDA submission process (PMA supplement)

Key Considerations

Clinical testing

  • Clinical study information should be described in a way meaningful to patients
  • Results should use actual numbers rather than percentages
  • Include purpose, objectives, study design, and key safety/effectiveness outcomes
  • Include contrast sensitivity testing outcomes

Human Factors

  • Patient labeling should be tested with representative users in controlled situations
  • Iterative testing to ensure comprehension of critical information
  • Users should demonstrate adequate comprehension through recitation

Labelling

  • Written in simple, lay language
  • Include clearly labeled graphics
  • Include patient decision checklist with acknowledgment sections
  • Provide balanced presentation of benefits and risks
  • Include description of eye and surgery, purpose, benefits, alternatives, risks
  • Include what to expect before, during, and after surgery
  • Include manufacturer and provider contact information

Safety

  • Include detailed description of risks and complications
  • Present most severe and frequent risks first
  • Include visual symptoms with explanatory images
  • Include long-term risks and complications

Other considerations

  • IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices

Original guidance

  • Patient Labeling for Laser-Assisted In Situ Keratomileusis (LASIK) Devices
  • HTML / PDF
  • Issue date: 2022-07-28
  • Last changed date: 2022-10-07
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Ophthalmic, Labeling, Premarket Approval (PMA)
  • ReguVirta summary file ID: 4477de3f65130dccb75280de6e9be90a
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