What are the responsibilities of a US Agent?

US Agent Responsibilities.

  1. Acting as an intermediary for communications between the FDA and foreign companies.
  2. Provides assistance to answer any questions concerning the foreign establishment’s devices that are imported or offered for import into the United States
  3. Assists the FDA to schedule inspections of the foreign establishments
  4.  Acts as a representative for the foreign company, and can receive documents and information from the FDA on their behalf

FDA communicates with foreign companies through US Agent. It is important that your US Agent should understand the importance of regulatory communication and promptly act when necessary.

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