* Please note that we do NOT provide US Agent representation for FOOD or PHARMACEUTICAL companies.
Common questions regarding US FDA Agent representation
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.
Additional services for United States:
- Consulting & Training for Medical Device Unique Device Identification (UDI) Requirements
- FDA 510(k) Submission Consulting and Approval
- FDA eMDR Adverse Event Reporting for Medical Device Companies
- FDA QSR Consulting
- FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)
- FDA US Agent Medical Devices in USA
- FDA認証（許可）取得のためのFDA 510(k)申請
- Human Factors Engineering (HFE) and Usability Testing for Medical Devices
- US FDA Consulting for Medical Device and IVD Manufacturers
- US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
- US FDA Medical Device Classification System
- US FDA Medical Device Establishment Registration
- US FDA Official Correspondent for Medical Device Companies
- US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices