Some companies avoid FDA REGISTRATION until their shipment is DENIED ENTRY by the U. S. Customs and Border Protection (CBP), or they have to deal with FDA detention without physical examination (DWPE). Not recommended
Do you know whether or not your company is on the FDA's Green List or Red List? Any idea what that means?
FDA detention without physical examination - DWPE. Sounds familiar?
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent for that establishment.