A : → Eyeglasses considered as medical devices in the US, are regulated under the Food, Drug and Cosmetic Act (FD&C Act) by the US Food and Drug Administration. They subject to the Class I General Controls in the FD&C Act which requires the US manufacturers or the distributors to file the initial premarket notification with the FDA, on company establishments and list of generic type of devices, prior to the commercial distribution. However, subsequent FDA clearance per shipment is not required before marketing in the US. As an overseas manufacturer, you may either request your importer to furnish the requirement for the shipment or if you are an OEM manufacturer for a US company, the US company initial registration on the product will do.
Q : → Is it necessary for an eyeglasses company to register with the FDA prior to its exports to the US?
