The European Union comprises 28 countries that require CE Marking . Three additional countries (Norway, Iceland, Liechtenstein), although not officially part of the European Union,...
US FDA Agent Representation for Medical Device and IVD Companies
ANSWERED ON THIS PAGE:
- What is the representation requirement in the United States?
- What are the responsibilities of a US Agent?
- Can we appoint a distributor as our US Agent?
The United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a presence 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 physical place of business in the US. Your US Agent serves as a liaison between your company and the FDA.
What are the responsibilities of a US FDA Agent?
Appointing a US Agent is more than a regulatory obligation. The responsibilities of the US Agent include:
- assisting the FDA in communications with your company;
- responding to questions concerning your imported products sold in the US;
- assisting the FDA in scheduling inspections of your facilities.
The FDA may also provide information or documents to your US agent, which is considered equivalent to providing them to your company. For this reason, it is important to appoint a professional, dependable regulatory firm to represent your interests.
Appoint Emergo as your US FDA Agent
Since 1997, Emergo has served as an official US Agent for 180+ medical device and IVD companies from 30+ countries worldwide. Here is why you should choose us:
- Emergo is the largest regulatory consulting firm dedicated to medical devices and IVDs worldwide. We are compliance specialists in this field.
- We have an entire team dedicated to serving our representation clients so you can be assured we will always handle your regulatory responsibilities professionally, confidentially, and promptly.
- As an independent "third party" representative, we look after your interests first. Read more about the benefits of appointing an independent US Agent.
- We can 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.
- Unlike most other consulting firms offering representation, Emergo maintains employee-staffed offices you can contact in Germany, France, UK, Netherlands, Japan, Australia, Canada, and many other countries.
Hiring Emergo as your US Agent is a small price to pay to ensure professional representation for your company.
* Please note that we do NOT provide US Agent representation for FOOD or PHARMACEUTICAL companies.
Common Questions
What is an Official Correspondent?
The Official Correspondent is the person identified in the establishment registration that the FDA will try to contact first if an issue arises. However, unlike the US Agent, the Official Correspondent does not need to be located in the US and may be a representative of your company. Although it is not required, companies sometimes prefer to appoint Emergo as their Official Correspondent to be the first point of contact with FDA officials, ensuring the proper handling of inquiries from FDA officials.
Why is it better to hire a professional regulatory firm instead of a distributor?
Distributors are in the business of selling your products and are not experts in regulatory matters. What happens if there is an incident with your products in the USA? Will your distributor know how to handle the situation if the FDA calls them? What happens if you switch distributors and need to find a new US Agent? As a professional regulatory firm, we work for you and will always make sure your interests are served.