Effective February 11, 2002, Foreign firms must register with the FDA and designate a US Agent. The final rule requires foreign establishments, whose products are imported or offered for import into the United States, to register with the FDA and to identify a United States agent. The responsibilities of the United States agent include: Assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assisting FDA in scheduling inspections of the foreign establishment.

Solution:

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