Regulatory Requirements for Decorative Non-Corrective Contact Lenses
This guidance explains how FDA regulates decorative, non-corrective contact lenses intended to change the appearance of normal eyes following the addition of section 520(n) to the Federal Food, Drug, and Cosmetic Act. It clarifies that all contact lenses, including decorative ones, are regulated as medical devices and require premarket authorization and prescription.
Recommended Actions
- Submit appropriate premarket notification (510(k)) or premarket approval application (PMA) before marketing
- Implement Quality System regulation requirements
- Ensure proper prescription-only distribution system
- Develop compliant labeling including risks and safety instructions
- Establish professional fitting and supervision protocol
- Set up system for regular patient check-ups and follow-up care
- Ensure import compliance if applicable
- Prepare for potential FDA inspections
- Maintain documentation of compliance with all applicable regulations
- Train staff on prescription requirements and distribution restrictions
Key Considerations
Human Factors
- Must be fitted properly by a qualified eye care professional
- Requires appropriate professional supervision and regular check-ups
- Users must obtain proper instructions for using contact lenses
Labelling
- Must comply with prescription device labeling requirements (21 CFR 801.109)
- Must include information about risks and proper instructions for safe use
Safety
- Must be dispensed only upon prescription order
- Professional supervision required to control risks
- Associated risks include corneal ulcer, infection, scarring, vision impairment, blindness
- Other risks include conjunctivitis, corneal edema, allergic reactions, and visual complications
Other considerations
- Subject to general controls of the Act
- Must comply with Quality System regulation (21 CFR Part 820)
- Requires either cleared 510(k), approved PMA, or IDE exemption
- Cannot be marketed as over-the-counter products
- Subject to FDA inspection
- Imported lenses without proper authorization subject to detention
Relevant Guidances
- Testing and Performance Requirements for Soft Daily Wear Contact Lenses
- Orthokeratology Rigid Gas Permeable Contact Lenses - Premarket Submissions and Clinical Testing Requirements
- Contact Lens Care Product Labeling: Warnings, Instructions and Readability Requirements
- Adding Lens Finishing Laboratories to Class III Rigid Gas Permeable Contact Lens PMAs
Related references and norms
- 21 CFR Part 820: Quality System Regulation
- 21 CFR 801.109: Prescription Device Labeling
Original guidance
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