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US FDA Agent Representation For Medical Device and IVD Companies

US FDA Agent for more than 270 medical device companiesThe United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a location in the United States to appoint a registered US FDA Agent.

The US FDA Agent must be a resident of the United States or maintain a place of business in the US. Your US Agent will serve as a liaison between your company and the FDA.

Appoint Emergo as your US FDA Agent

Since 1997, Emergo has served  as an official FDA Agent for more than 100 medical device and IVD companies from 25+ countries worldwide. Here’s why you should choose us:

  •  We will communicate with the FDA on your behalf and respond to any questions concerning your medical devices.
  • We focus on regulatory compliance and will ensure that all of your regulatory responsibilities are handled professionally, confidentially and promptly.
  • As an independent "third party" representative, we will always look after your interests first and foremost. Manufacturers who appoint a distributor to act as their FDA US Agent can experience challenges in this regard. Read more about the benefits of appointing an independent US Agent
  • We can also represent your company as an in-country representative in 20+ other markets worldwide. No other consulting firm in the world offers a single source for representation in all of these markets.

Please contact us for more information on US FDA Agent representation. Ask about our special three year package for new US Agent representation clients.

Ask us for detailed information about USA FDA agent services.

Learn about the process, costs and timelines.

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* Please note that we do NOT provide US Agent representation for FOOD or PHARMACEUTICAL companies.