US Agent, Clinical Trials

The Need for an Agent for Clinical Trials in the US

In Clinical, European Market, FDA, Regulatory by Nicole Feist and Anney Majewski

Our last post reviewed the requirements stated in Directive 2007/47/EC for selecting an Authorized Representative in the EU as well as the qualifications to act as an Authorized Representative. While many companies choose to conduct clinical trials in the EU, several others prefer the US. Similar to EU standards, the Food and Drug Administration (FDA) requires any company located outside of the country that chooses to perform clinical trials to identify a US Agent for representation.

To act as a US Agent for clinical trials, the company must have an established place of business in the US, whether it is the headquarters or a maintained location. A post office box is not deemed an acceptable form of address for the US Agent. Also, the established US Agent is obligated to have an employee available to answer the phone during normal business hours. Businesses that only have an answering service will not be approved as a US Agent.

When choosing a US Agent, the non-US based company can only designate one. Once a US Agent has been selected, their information needs to be submitted electronically using the FDA’s Unified Registration and Listing System (FURLS). The US Agent’s name, address, telephone number, fax number and email address must be provided. The non-US based company may then assign the US Agent as its official correspondent if desired. FDA defines an official correspondent as, “the person designated by the owner/operator of an establishment responsible for the annual registration of the establishment and the device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.”

Who you choose to represent your business in another country should not be taken lightly. Having an Authorized Representative or US Agent is very beneficial beyond being a requirement set by regulatory agencies.

To read the next blog in this series, Responsibilities of an Authorized Representative and US Agent, click here.
If you missed the previous blog in this series, The Need for an Authorized Representative for Clinical Trials in the EU, you can view it here.

Authors:

Nicole Feist, BA (nfeist@namsa.com) is a Medical Research Manager with NAMSA. Before joining NAMSA, Nicole held senior-level clinical positions at medical device organizations and contract research organizations. She specializes in helping companies create strategic clinical pathways for adoption of new technologies by developing and managing first-in-human, IDE, and postmarket clinical trials for US and outside-US approval.

Anney Majewski is the Marketing Communications Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the medical device industry. She obtained a BBA in Marketing from the University of Toledo as well as an A.S. in Psychology from Monroe County Community College.