United Source provides the service assisting foreign manufacturer to apply COVID-19 Emergency Use Authorizations for Medical Devices and Personal Protective Equipment.
Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States are required to register with FDA annually. Firms involved in manufacturing, packaging, labeling or reprocessing of devices must pay an annual fee. Many establishments that are required to register with FDA also are required to list their devices.
United Source is here to assist.
United Source is a FDA registered initial importer and as such authorized to facilitate the marketing of devices from a foreign manufacturer to the person who makes final delivery or sale in the USA.