CENIT Consulting as your US FDA Agent

us fda agent

According to the United States Food and Drug Administration (FDA), all registered medical device establishments located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s products.

Each foreign establishment may designate only one U.S. agent.

The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. 

Requirements of a U.S. agent / FDA Official Correspondent:

  • The U.S. agent must either reside in the United States or maintain a place of business in the United States.
  • The U.S. agent cannot use a post office box as an address.
  • The U.S. agent cannot use just an answering service.
  • The U.S. agent must be available to answer the phone or have an employee available to answer the phone during normal business hours.
Responsibilities of a U.S. agent / FDA Official Correspondent

The responsibilities of the U.S. agent are limited and include:

  • assisting 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 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.

Please note that the U.S. agent has no responsibility related to:

  • Reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803)
  • Submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

Other U.S.-related services

In addition to U.S. Agent services, CENIT can also assist you with the following:

 FDA Registration and Renewal

  • Medical device establishments that produce and distribute products for use within the U.S. must register and renew their registration annually. Products manufactured and/or distributed for use within the U.S. must also be registered when brought into the U.S. market

FDA UDI and GUDID Compliance Solutions

  • Under the FDA Unique Device Identifier (UDI) rule, most medical device labels and packages must bear a UDI. The device labeler must apply the UDI and submit device information, including a device identifier (DI), product codes, and other characteristics to the Global Unique Device Identification Database (GUDID).

Master File Submission

To designate CENIT Consulting as your U.S. Agent, simply start the process by completing the form below.

Our Fees

payment
  • FDA U.S. Agent (Annual Registration) $1200 *

    FDA registration for establishment and products - Registration updates - Medical device reporting - U.S. regulatory contact - UDI regulatory contact

  • FDA UDI and GUDID Submission

  • Assignment and registration of device configurations:

  • - Single device configuration $100

  • - Group of 10 device configurations $500

  • - Group of 25 device configurations $1000

  • - More than 25 device configurations, contact for pricing

  • All FDA related correspondence

    All FDA related correspondence and/or documents received and/or delivered on behalf of client as a registered U.S. Agent will be billed at our hourly rate plus applicable shipping costs

  • * Fees are updated for 2023 and may be subject to changes.