Role of US Agent (FDA Agent)

The United States Food and Drug Administration (FDA) require all medical device, IVD and pharmaceutical companies without a location in the United States to appoint a registered US FDA Agent. An appointed US FDA Agent must be a resident of the United States OR maintain a place of business in the US. Each foreign establishment may designate only one U.S. agent The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

Responsibilities of a U.S. Agent

  • Assisting FDA in communications with the foreign establishment,
  • Maintain a place of business in the United States including a telephone, email and fax.
  • Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
  • Assisting FDA in scheduling inspections of the foreign establishment and if FDA is unable to contact the foreign establishment directly or expeditiously, 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.

US Agent does NOT

  • U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E)

Advantages of appointing I 3 Consulting as your U.S. Agent

  • Manufacturers who appoint a distributor to act as their FDA US Agent can experience difficulties if any undue happens with your product.
  • Very reasonable yearly fee.
  • We can also represent your company as an in-country representative in Europe, China and India. Very few consulting organization offers such services in these countries.

Contact us for more information

INDIA -Bangalore
+ 91 994 591 2081
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USA -Chicago
+1 630 696 1293
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+49 2161 990 8831
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