As part of the FDA facility registration and product listing, you need to appoint an Official Correspondent.
Foreign companies must also designate a U.S. Agent.
US Agent
In accordance with U.S. FDA regulations, any foreign establishment engaged in the manufacture of a device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment. Each foreign establishment may designate only one U.S. Agent and provide the FDA with the name, address, telephone and fax numbers and e-mail address of the U.S. Agent. The foreign establishment may also, but is not required to, designate its U.S. Agent as its Official Correspondent.
The responsibilities of the U.S. agent include:
* Assisting the FDA in communications with the foreign establishment
* Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States.
* Assisting the FDA in scheduling inspections of the foreign establishment and if the FDA is unable to contact the foreign establishment directly or expeditiously, the FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Official Correspondent
An Official Correspondent is defined as the person designated by the owner or operator of an establishment responsible for the annual registration of the establishment and the device listing. The Official Correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments. The Official Correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned. The Official Correspondent can:
* Create new registrations and listings
* Make changes, updates and cancellations to registrations and listings that have been assigned to them.
* Add their establishment(s) to listings previously entered for the owner/operator.
* View registration and listing information for the establishments which have been created by or assigned to them.
* View the non-exempt listings that must be replaced for the establishments which have been assigned to them.
Firms like http://www.FDARegistration.net have represented hundreds of non-U.S. companies as their U.S. Agent and Official Correspondent to the FDA. They offer fast and reliable registration solutions for companies seeking to comply with FDA regulations and FDA standards in order to market their food products in the United States.
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