FDA US Agent – Pineprep

SERVICE

FDA US Agent Representation

Designate Pineprep as your registered US FDA Agent. We will serve as the liaison between FDA and your medical device or IVD company.

FDA US Agent Representation

The United States Food and Drug Administration (FDA) mandates that all medical device and in vitro diagnostic (IVD) companies without a presence based in the US (foreign establishment) must designate a registered US FDA Agent. This requirement is applicable to any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the US. US Agent must reside in the US or maintain a physical business location in the US and be available to answer the phone during normal business hours. The US Agent acts as a liaison between FDA and foreign establishment.

Responsibilities of a FDA US Agent

Beyond fulfilling a regulatory requirement, designating a US Agent will obligate the US Agent to be responsible for:

Assisting FDA in communications with the foreign establishment
Responding to questions concerning the foreign establishment’s devices 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 U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Therefore, choosing a professional and trusted regulatory service provider to represent your interests is important.

*Please note that the U.S. 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).

Designate Pineprep as your US FDA Agent

Located in Washington D.C. metropolitan area, Pineprep will serve professionally as your company’s US Agent.

Here are some reasons to choose us:

Pineprep is a professional regulatory consulting firm focused on medical devices and IVDs globally, with expertise in compliance.
We are dedicated to ensuring professional, confidential, and prompt handling of your regulatory responsibilities.
As an independent third-party representative, we prioritize your interests first.
We provide other complementary services such as obtaining Certificate to Foreign Government (CFG), getting documents apostilled or legalized and consulting on regulatory affairs.
Pineprep is located near Washington DC and can properly handle regulatory affairs that require correspondence with US federal government agencies (e.g., FDA, Department of State, Department of Justice, etc.) and diplomatic offices of various countries (e.g., embassies, consulates)

Hire Pineprep as your US Agent to ensure professional representation for your company.

*Please note that our US Agent representation service for food or pharmaceutical companies are not yet available. Currently, we can represent only medical device and IVD companies.

Frequently Asked Questions

What is an Official Correspondent?

The Official Correspondent is the contact person listed in the FDA establishment registration that the FDA will initially reach out to if an issue arises. Unlike the US Agent, the Official Correspondent does not need to be located in the US and may be a representative from your company. Although not required, your company may designate other company like Pineprep as the Official Correspondent to ensure communication with FDA officials is handled professionally.

Why is a regulatory firm better suited for US Agent than a distributor?

Distributors prioritize selling your products and typically do not have the expertise in regulatory matters. As an independent third-party representative, a professional regulatory firm will focus on representing and protecting your interests first and will know how to handle various situations if FDA contacts regarding issues with your products in the US. Also, designating a distributor as your US Agent can be problematic if you decide to change distributors and need a new US Agent.

We offer a diverse range of regulatory services.

Our services are focused on assisting medical device and IVD companies achieve regulatory and standard compliance.

Contact us to learn more about our FDA US Agent service.

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