REGULATORY SERVICESRCRI® as your US Agent
RCRI® has extensive experience serving as US Agent for our global clients. The fee for this service is a base price per year. Other activities involved with FDA communication, establishment registration, etc. are provided at an hourly rate. Please contact Juli Denny, Director of Business Development for more information. jdenny@rcri-inc.com or 952-224-2263.
Why is a US Agent Necessary?
Per the Establishment Registration (Form 2891), establishments outside of the United States must designate a US Agent and an Official Correspondent. A detailed explanation of the purpose and responsibility of a US Agent, along with instructions for a foreign firm to designate a US Agent, may be found on the FDA website at: http://www.fda.gov/cdrh/deviadvice/341.html.
A brief summary of that information is provided below.
Effective February 11, 2002, all foreign establishments must notify FDA of the name, address and phone number of their United States Agent. The United States Agent must either reside in the U.S. or maintain a place of business in the U.S and be available to answer the phone or have an employee available to answer the phone during normal business hours.
Responsibilities of a United States Agent
The United States agent must either reside in the U.S. or maintain a place of business in the U.S. The United States agent cannot use a post office box as an address. The United States agent cannot use just an answering service. The agent must be available to answer the phone or have an employee available to answer the phone during normal business hours. The responsibilities of the United States agent are limited. They include: - Assisting FDA in communications with the foreign establishment
- Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States
- Assisting FDA in scheduling inspections of the foreign establishment
- If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Similarly, the regulation outlining requirements for submitting a Premarket Approval Application (21 CFR 814.20(a)) requires that a foreign applicant identify an "authorized representative residing or maintaining a place of business in the United States." Again, the same agent may satisfy both requirements.
Please note that the United States 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)
Responsibilities of the Official Correspondent
The Official Correspondent is the person designated by the owner/operator to be responsible for: - The annual registration of the establishment
- Contact with FDA for annual establishment registration and medical device listing issues
- Maintenance and submission of a current list of officers and directors to FDA upon request
- The receipt of pertinent correspondence from FDA directed to and involving the owner/operator and/or any of the firm's establishments
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