If you need a trusted US Agent backed by regulatory experts, NSF can keep your US market entry on track.
If you’re a medical device company based outside the US, appointing a US Agent is more than just an FDA requirement — it’s a critical part of your regulatory success.
But not all agents are created equal.
We provide US Agent services backed by regulatory expertise, so you’re not just meeting the requirement but also working with someone who understands what’s at stake.
What we do:
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Represent you as your official FDA point of contact
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Respond to FDA enquiries on your behalf
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Guide your team through 510(k) submissions and compliance needs
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Help you avoid costly delays and misunderstandings
What sets us apart:
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We’re part of NSF, a global organisation with deep regulatory expertise
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Our team includes former FDA regulators and industry professionals
We’ve supported medical device companies worldwide with FDA submissions, inspections, and US market entry. And we’re here to support you, too — with experience far beyond paperwork.
Have questions or ready to get started? Fill out the form below and we will be in touch soon.
Frequently asked questions about FDA U.S. agents
Who needs an FDA U.S. Agent?
Any foreign company that wants to market regulated products in the United States must appoint an FDA U.S. Agent. This includes:
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Foreign manufacturers producing devices for the U.S. market
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Foreign contract manufacturers making devices for U.S. distribution
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Foreign specification developers that design or define device specifications for U.S. sales
Why does a foreign company need an FDA U.S. Agent?
FDA requires all non-U.S. establishments to designate a U.S. Agent so the agency has a reliable contact within the United States. Without one, FDA may refuse registration, which prevents products from being legally imported or sold in the U.S.
What is the role of an FDA U.S. Agent?
A U.S. Agent serves as the official point of contact between FDA and a foreign company. Their responsibilities include:
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Acting as a liaison for all FDA communications
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Answering FDA questions about devices
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Helping schedule and facilitate inspections of foreign facilities
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Ensuring establishment registrations and device listings are accurate and up to date
What are the requirements for an FDA U.S. Agent?
To qualify, an FDA U.S. Agent must:
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Have a permanent physical address in the United States
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Be available during normal U.S. business hours to communicate with FDA
What is the difference between an FDA U.S. Agent and a distributor?
A distributor markets and sells your products in the U.S., but this does not meet FDA’s requirement for a U.S. Agent. An FDA U.S. Agent is a separate, legally required role responsible solely for official communication with FDA — even if you already have a distributor.
How do I appoint an FDA U.S. Agent?
You designate your FDA U.S. Agent during the FDA Establishment Registration process. If you already have a registration, you can update it to include your chosen U.S. Agent.
