What are DHHS requirements for medical and non-medical products?
FDA agrees that if a foreign establishment sends human drugs, animal drugs, devices, or biological products to a foreign trade zone, the foreign establishment is required to register or list its products. FDA works closely with the USA Customs Service on issues affecting the importation and exportation of FDA regulated products. If unsure which product review division to contact, contact Office of Compliance and Biologics Quality of FDA or ask Lark.
