Color Additives in Contact Lenses: Preparing and Submitting Petitions
This guidance assists industry in preparing color additive petitions (CAP) for use in or on contact lenses. It outlines data requirements and provides recommendations for FDA to assess the safety of color additives in contact lenses, including exposure estimation methods for different types of contact lenses (daily-wear, extended-wear, etc.).
Recommended Actions
- Submit protocol for migration study to FDA for review before initiating testing
- Conduct required toxicology testing if color additive not already approved for eye area use
- Prepare comprehensive chemical characterization including identity, composition, and specifications
- Calculate potential exposure based on migration study results or worst-case scenario
- Prepare environmental documentation (categorical exclusion claim or environmental assessment)
- Submit CAP directly to CFSAN with appropriate fees
- Consider separate timing for CAP review (up to 180 days) and 510(k)/PMA submissions
- Validate analytical methods for color additive detection and quantification
- Document manufacturing process and quality control specifications
- Prepare safety justification based on exposure calculations and toxicology data
Key Considerations
Non-clinical testing
- Three Week Ocular Irritation Test in Rabbits (Draize test) using both colored and uncolored lenses
- Guinea Pig Maximization Test using extracts of colored and uncolored lenses for contact sensitization
- No additional toxicological testing needed if color additive is already approved for eye area use in cosmetics
Biocompatibility
- Migration studies required at 37°C for appropriate time periods
- Extraction testing using saline solution or phosphate-buffered saline
- Analysis of color additive migration and exposure calculations
Safety
- Cannot list color additives that induce cancer in appropriate safety tests
- Risk assessments required for additives containing carcinogenic impurities
- Safety data must establish that the color additive is safe for intended use
Other considerations
- Chemical identity and specifications must be provided
- Manufacturing process description required
- Environmental assessment or categorical exclusion claim needed
- Prescribed fees: $2600 for new color additive, $1600 for extending use of listed color additive
Relevant Guidances
- Color Additives in Medical Devices: Requirements for Direct Body Contact Applications
- Color Additive Petitions: Chemical and Technical Requirements for Food, Drugs, Cosmetics, and Medical Devices
Related references and norms
- USP 28-NF 23: Biological Reactivity Tests
Original guidance
- Color Additives in Contact Lenses: Preparing and Submitting Petitions
- HTML
- Issue date: 2006-05-01
- Last changed date: 2024-10-01
- Status: FINAL
- Official FDA topics: Medical Devices, Food & Beverages, Food & Color Additives
- ReguVirta summary file ID: 8dfeb4b79409f24f6890906a5191eb9c
This post is licensed under CC BY 4.0 by the author.