"This product has been identified as a corrective lens or prescription eyeglasses, which is a prescription use only medical device." on Amazon: what it means

A seller reports this violation for sunglasses and goggles, and says they couldn't find prescription claims in the listing. The notice identifies prescription use. If your product is ordinary sunglasses, the checks below address its eyewear paperwork rather than resolving that classification dispute.

The things you must have

• Eyewear impact resistance certificate: Ask your manufacturer for its impact test certificate; you'll include it with each shipment.

• FDA device registration and listing: Your factory registers and lists devices with FDA; you'll ask for those records.

• Country of origin marking: Your factory supplies English markings.

Check these first

If your product is sunglasses, you'll need the lens impact resistance certificate when asking your factory for the safety documents that cover the supplied lenses. If your sunglasses need their lens testing checked, ask your factory for the drop ball testing when reviewing the impact resistance evidence for those lenses. If your sunglasses are made by a foreign factory, check that factory's FDA registration and product listing when reviewing its documentation for the manufactured eyewear. If your sunglasses are made outside the country, ask your factory who its United States agent is when checking its FDA registration arrangements for eyewear. If your business imports sunglasses for resale, you'll need to check the record retention requirement when deciding how to keep the documents for those imports.