Contact Lenses

Yes. FDA classifies all contact lenses — including zero-power cosmetic lenses — as prescription medical devices. They require 510(k) clearance or equivalent premarket authorization, must be labeled as prescription devices, and may only be sold with a valid prescription. Importers of cosmetic lenses should verify that their products have the appropriate FDA clearance and that the foreign manufacturer is registered with FDA, as non-compliant shipments are subject to detention at the port of entry.

Importers should be prepared to provide the FDA establishment registration number of the foreign manufacturer, the device listing number, evidence of 510(k) clearance or PMA approval for each lens type, and compliant labeling. CBP transmits entry data to FDA's PREDICT system, which flags shipments for examination. Having these documents readily available — and ensuring the foreign establishment is current in its FDA registration — significantly reduces the risk of detention or refusal.