The short answer
In the U.S., every contact lens is a medical device — including colored, decorative and zero-power “cosmetic” lenses. They need FDA clearance or approval before sale, and the factory must be registered and inspected.
What exporters should watch for
👁️ All lenses are devices
A U.S. law from 2005 made decorative, non-corrective contact lenses medical devices, the same as corrective lenses. They cannot be sold as cosmetics or fashion accessories.
📁 Clearance or approval
Contact lenses need FDA premarket clearance (510(k)) or approval depending on the lens type and wear schedule. A lens without its own FDA clearance or approval cannot be imported for sale.
🏭 Registration and quality
The factory registers with FDA every year, lists its lenses, names a U.S. Agent, pays FDA’s annual fee and follows the QMSR quality system rule.
📋 Prescription sale
In the U.S., contact lenses — including colored lenses — may only be sold with a valid prescription. Selling them as over-the-counter beauty products is illegal.
Common reasons shipments are stopped
- Colored or decorative lenses sold without FDA clearance
- Lenses sold as cosmetics or without a prescription
- Factory not registered or lenses not listed
- Quality system findings
- Misleading labels claiming “FDA approved” without clearance
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Are colored contact lenses without power regulated by FDA?
Yes. Since 2005, all contact lenses — including colored, decorative and zero-power lenses — are medical devices in the U.S. They need FDA clearance or approval, the factory must be registered, and they can only be sold with a prescription.
Can I sell my CE-marked contact lenses in the U.S.?
Not on CE marking alone. You need FDA clearance or approval for the specific lens, FDA establishment registration, device listing, a U.S. Agent and compliance with FDA’s quality system rule.
Sources
- FDA — Decorative, non-corrective contact lenses (guidance)
- FDA — Quality Management System Regulation (QMSR)
- FDA — Import Alerts by Publish Date
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.