Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Testing and Clinical Requirements

Recommended Actions

1. Develop comprehensive test plan covering all non-clinical requirements
2. Design clinical study protocol with required follow-up periods and endpoints
3. Establish biocompatibility testing program
4. Validate sterilization process and package integrity
5. Develop shelf life testing protocol
6. Create detailed adverse event monitoring plan
7. Consider submitting Pre-Submission to FDA for feedback
8. Establish post-market surveillance plan for long-term follow-up
9. Prepare documentation demonstrating compliance with all testing requirements
10. Validate manufacturing process including dimensional tolerances

Key Considerations

Clinical testing

• Minimum 12-month follow-up required for all subjects
• Washout period required before surgery and at key timepoints
• Inclusion criteria: Early or moderate open angle glaucoma with specific visual field and optic nerve criteria
• Primary effectiveness endpoint: ≥20% reduction in mean diurnal IOP from baseline
• Secondary effectiveness endpoint: Mean diurnal IOP change from baseline

Non-clinical testing

• Testing should be performed on finished sterilized product
• Physical and mechanical testing per ANSI Z80.27
• Structural integrity testing
• Insertion testing if device has delivery system
• Additional testing for coated and metallic devices

Biocompatibility

• Cytotoxicity, sensitization, ocular irritation testing required
• Systemic toxicity, sub-chronic toxicity, genotoxicity testing
• Carcinogenicity and pyrogens testing
• Ocular implantation testing per ANSI Z80.27
• Additional testing for bioabsorbable materials

Safety

• Monitor for adverse events including hypotony and chronic anterior uveitis
• Track device removals and reasons
• Safety follow-up may be required up to 5 years

Other considerations

• Sterility validation required
• Package integrity testing needed
• Shelf life and shipping stability studies required
• Bacterial endotoxin limit ≤0.2 EU/device

  Relevant Guidances

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Submission Requirements for Terminally Sterilized Medical Devices
• Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

Related references and norms

• ANSI Z80.27: American National Standard for Ophthalmics – Implantable Glaucoma Devices
• ISO 10993-series: Biological evaluation of medical devices
• ISO 11979-5: Ophthalmic Implants – Intraocular Lenses – Part 5: Biocompatibility
• ASTM F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
• ISO 17665-1: Sterilization of Health Care Products – Moist Heat
• ISO 11135: Sterilization of Health Care Products – Ethylene Oxide
• ISO 11607-1: Packaging for Terminally Sterilized Medical Devices

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Original guidance

• Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Testing and Clinical Requirements
• HTML / PDF
• Issue date: 2015-12-15
• Last changed date: 2020-03-02
• Status: FINAL
• Official FDA topics: Medical Devices, Ophthalmic, Premarket, Premarket Approval (PMA)
• ReguVirta summary file ID: 2f1b7eb19ac01d6fd2a6f4c14f3600f3