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.

Marketing food products within the Unites States presents a very promising business opportunity for both U.S. and non-U.S companies.

Without appointing a U.S. Agent for foreign companies and registering your food, beverage, or dietary supplements facility, your products will be denied from entering the U.S.

As required by The Bioterrorism Act of 2002 and due to strict regulations, all foreign food facilities are required to appoint a U.S. Agent and register with the FDA in order to receive a Registration Number. If an actual or potential bioterrorism incident or an outbreak of food-borne illness occurs, registration information will help the FDA determine the location and source of the event and permit the agency quickly notify the facilities that may be affected. Foreign facilities that manufacture, process, handle, treat, pack, or store food also require FDA certification.
Severe consequences of non-compliance with FDA standards range from shipment detention at the U.S. customs to significant monetary fines and other legal enforcement measures. Simply put, if you do not comply and obtain an FDA Registration Number, your shipments will not be allowed entry into the USA.

Firms like FDARegistration.net are able to quickly and securely process FDA registration submission online for US and non US companies. They offer fast and reliable registration solutions and U.S. agent representation for companies seeking to comply with FDA regulations and FDA standards in order to market their food products in the United States. Registering food facilities is the first step in having sucess in the U.S. market.

Owners or operators of places of business (establishments) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration. There is a fee for annual establishment registration for some establishment types.

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).

The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted.

Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

Firms like FDARegistration.net are able to quickly and securely process FDA registration submission online for US and non US companies. They offer fast and reliable registration solutions and U.S. agent representation for companies seeking to comply with FDA regulations and FDA standards in order to market their medical device products in the United States. Registering medical device facilities and listing medical device products is the first step in having sucess in the U.S. market.