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.
What You Need to Know? 👇
What regulatory classification applies to decorative contact lenses under FDA law?
All decorative contact lenses are regulated as medical devices under section 520(n) of the Federal Food, Drug, and Cosmetic Act, regardless of whether they provide vision correction. They require FDA premarket authorization through 510(k) clearance or PMA approval.
Can decorative contact lenses be sold over-the-counter without a prescription?
No. Decorative contact lenses cannot be marketed as over-the-counter products. They must be dispensed only with a valid prescription from a qualified eye care professional, just like corrective contact lenses, due to significant safety risks.
What are the main health risks associated with unsupervised decorative contact lens use?
Risks include corneal ulcers leading to internal eye infection, corneal scarring, vision impairment, blindness, conjunctivitis, corneal edema, allergic reactions, abrasions from poor fit, and reduced visual acuity that can interfere with daily activities like driving.
What premarket requirements must manufacturers meet before selling decorative contact lenses?
Manufacturers must obtain FDA clearance through 510(k) submission or PMA approval before marketing. They must also comply with Quality System regulations (21 CFR Part 820), proper labeling requirements, and other applicable device regulations and statutory requirements.
How does FDA enforce compliance for imported decorative contact lenses?
FDA uses Import Alert #89-08 to automatically detain non-compliant decorative contact lenses at US ports of entry. Imported lenses without proper FDA premarket authorization are subject to detention without physical examination under federal import procedures.
What steps should consumers take before purchasing decorative contact lenses?
Consumers must see a qualified eye care professional for proper fitting, obtain a valid prescription, receive instructions for safe use, and maintain appropriate follow-up care. Professional supervision is essential to minimize serious eye injury risks.
What You Need to Do 👇
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