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.
Recommended Actions
- Obtain FDA approval of protocol for adding finishing laboratories
- Develop comprehensive documentation package for finishing laboratories
- Establish quality assurance program covering all required activities
- Implement monitoring and surveillance system for laboratories
- Create adverse reaction reporting system
- Prepare and maintain required documentation in device master records
- Include required information in annual reports to FDA
- Obtain signed declarations from laboratories and PMA holder
- Establish system for maintaining complaint files
- Ensure compliance with all labeling requirements
- Implement traceability system for manufactured lenses
- 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
- PMA holder must provide complete range of specifications and detailed process instructions
- Quality assurance activities must include:
- Incoming material specifications
- Acceptance/rejection criteria
- Processing compound specifications
- Final product acceptance criteria
- Packaging and labeling specifications
- Records maintenance and traceability
- Quality audit procedures
- Monitoring plan for continued surveillance required
- Two sworn declarations needed (from laboratory and PMA holder)
Relevant Guidances
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Quality System Information Requirements for Premarket Submissions
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms
- 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
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