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Adding Lens Finishing Laboratories to Class III Rigid Gas Permeable Contact Lens PMAs

This guidance outlines revised procedures for adding lens finishing laboratories to approved Premarket Approval Applications (PMAs) for Class III Rigid Gas Permeable (RGP) contact lenses for extended wear. It allows PMA holders to include additional finishing laboratories as manufacturers and distributors without submitting PMA supplements, provided they follow an approved protocol and meet specific documentation requirements.

  1. Obtain FDA approval of protocol for adding finishing laboratories
  2. Develop comprehensive documentation package for finishing laboratories
  3. Establish quality assurance program covering all required activities
  4. Implement monitoring and surveillance system for laboratories
  5. Create adverse reaction reporting system
  6. Prepare and maintain required documentation in device master records
  7. Include required information in annual reports to FDA
  8. Obtain signed declarations from laboratories and PMA holder
  9. Establish system for maintaining complaint files
  10. Ensure compliance with all labeling requirements
  11. Implement traceability system for manufactured lenses
  12. Set up quality audit procedures for ongoing compliance monitoring

Key Considerations

Non-clinical testing

  • Finishing laboratories must prepare at least 10 lenses from 10 different prescriptions for PMA holder inspection
  • Lenses must meet final product criteria of approved PMA specifications

Labelling

  • Complete and accurate copies of all approved labeling must be provided
  • Must include cautionary statement: “Caution: Non-sterile. Clean and condition lenses prior to use”

Biocompatibility

  • Evidence that lens material is not toxic must be provided
  • Lens must be able to be cleaned and disinfected satisfactorily

Safety

  • Adverse reaction reporting system must be established and maintained
  • Lens finishing laboratories must report adverse reactions within 10 days
  • Must comply with Medical Device Reporting (MDR) regulations

Other considerations

  • 21 CFR 814.39: PMA Supplements and Amendments
  • 21 CFR 820.3(t): Quality System Regulation - Quality Audit Definition
  • 21 CFR 801.109: Prescription Devices

Original guidance

  • Adding Lens Finishing Laboratories to Class III Rigid Gas Permeable Contact Lens PMAs
  • HTML / PDF
  • Issue date: 1998-08-10
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: af4602332d80116c1e4a63c1e12b98c3
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