All foreign establishments or facilities must notify the U.S. Food and Drug Administration (FDA) of the name, address, phone, and email address of their U. S. Agent.
This requirement applies to
* Food facilities
* Dietary supplements facilities
* Food canning establishments
* Cosmetics establishments
* Drugs establishments
* Medical devices establishments.
Responsibilities of the U. S. Agent
* Assist the FDA in communications with the foreign establishment
* Respond to questions concerning the foreign establishment’s products that are imported or offered for import into the United States, and
* Assist the FDA in scheduling inspections of the foreign establishment.
A U.S. Agent may also register the Foreign Food Facilities on behalf of foreign companies.
ITB HOLDINGS LLC as your company’s U.S. Agent for the purpose of FDA REGISTRATION
$99.00 USD Annual Fee
Free when combined with other services
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The initial importer of a medical device must register its establishment with FDA. An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
Always indicate the full name of your company (as registered), street address, city, postal / zip code, country and telephone number at the end of your message if you want a response. Emails without this information will be automatically deleted as spam or junk.