Contact Lenses

Contact lenses are Class II or Class III medical devices regulated by FDA's Center for Devices and Radiological Health (CDRH). Imported lenses must come from FDA-registered foreign manufacturers, and the specific lens design must hold a valid 510(k) clearance or PMA approval. FDA may detain shipments for admissibility review, and importers should ensure their foreign supplier's registration and device clearance are current before shipment. Consult a licensed customs broker or regulatory affairs specialist familiar with FDA device imports.

Yes. FDA regulates all contact lenses — including cosmetic, colored, and plano lenses — as medical devices regardless of whether they correct vision. This means non-prescription decorative lenses require the same 510(k) clearance, manufacturer registration, and prescription requirement under the Fairness to Contact Lens Consumers Act as corrective lenses. Importers of cosmetic lenses who overlook this requirement face significant enforcement risk.