Testing and Performance Requirements for Soft Daily Wear Contact Lenses
This guidance covers soft (hydrophilic) daily wear contact lenses that are Class II devices regulated under 21 CFR 886.5925. The scope is limited to: - Prescription devices for optical correction of ametropia - Made from polymacon, etafilcon A or hioxifilcon D materials - Spherical or toric lenses - Frequent replacement or daily disposable lenses - With handling/visibility tinting only The guidance explicitly excludes lenses for presbyopia, color enhancement, therapeutic use, keratoconus, special optical/physical/health performance, and those with novel materials or coatings.
What You Need to Know? 👇
What is the Safety and Performance Based Pathway for contact lenses?
The Safety and Performance Based Pathway is an optional FDA framework allowing manufacturers to demonstrate substantial equivalence by meeting FDA-identified performance criteria rather than direct comparison to predicate devices. This pathway reduces regulatory burden while maintaining safety standards.
Which contact lens materials are covered by this FDA guidance?
The guidance covers soft hydrophilic daily wear contact lenses made from three specific materials: polymacon, etafilcon A, and hioxifilcon D. These are well-established materials with extensive 510(k) submission history and proven safety profiles.
What biocompatibility testing is required for daily wear contact lenses?
Contact lenses require cytotoxicity, sensitization, and ocular irritation testing per ISO 10993 standards. However, if manufactured from identical materials and processes as predicate devices, rationale in lieu of testing may be acceptable.
Are colored or specialty contact lenses included in this guidance scope?
No, the guidance excludes lenses for presbyopia correction, color enhancement, therapeutic use, keratoconus management, blue light filtering, moisture retention, or any special optical/physical performance characteristics beyond basic ametropia correction.
What sterilization methods are acceptable under this guidance?
Only moist heat sterilization is covered in this guidance, requiring validation to sterility assurance level of 10⁻⁶. Other sterilization methods like ethylene oxide, radiation, or dry heat fall outside the guidance scope.
What packaging solution specifications must be met?
Packaging solutions must maintain pH between 7.2-7.4 and osmolality between 280-320 osmol/kg. These criteria ensure physiological compatibility and lens stability during storage before use.
What You Need to Do 👇
Recommended Actions
- Review device specifications to confirm it falls within the scope of the guidance
- Plan and execute required physicochemical and optical property testing:
- Spectral Transmittance
- UV Transmittance (if applicable)
- Refractive Index
- Water Content
- Specific Gravity
- Oxygen Permeability
- Extractables
- Conduct mechanical property testing:
- Modulus
- Tensile Strength
- Elongation at Break
- Perform packaging solution testing:
- pH
- Osmolality
- Validate sterilization process if device is labeled sterile
- Complete biocompatibility evaluation:
- Determine if testing is needed based on material equivalence
- If required, conduct cytotoxicity, sensitization and ocular irritation testing
- Prepare test reports and Declarations of Conformity as specified for each test
- Consider submitting a Pre-Submission if additional testing beyond guidance recommendations is deemed necessary
Key Considerations
Non-clinical testing
- Spectral Transmittance testing with specific criteria for each material
- UV Transmittance testing for materials with UV absorbers
- Refractive Index testing with material-specific criteria
- Water Content testing with material-specific criteria
- Specific Gravity testing with material-specific criteria
- Oxygen Permeability testing with material-specific criteria
- Extractables testing (<1% with water and hexane)
- Modulus testing with material-specific criteria
- Tensile Strength testing with material-specific criteria
- Elongation at Break testing with material-specific criteria
Biocompatibility
- Cytotoxicity testing required
- Sensitization testing required
- Ocular Irritation testing required
- Testing can be waived if using identical materials and processes as predicate device
Safety
- Packaging solution pH testing (7.2-7.4)
- Packaging solution osmolality testing (280-320 osmol/kg)
- Sterilization validation to SAL 10-6 for devices labeled as sterile
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
Related references and norms 📂
- ISO 18369-3: Ophthalmic optics - Contact lenses - Part 3: Measurement methods
- ANSI Z80.20: American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
- ISO 18369-4: Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
- ASTM D882: Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
- ISO 17665-1: Sterilization of health care products – Moist heat – Part 1
- ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1
- ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2
- ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
- ISO 10993-23: Biological evaluation of medical devices – Part 23: Tests for irritation