US Agent & FDA Official Correspondent

Your Direct Line to the FDA—Without Delays or Miscommunication

If you are a non-U.S. medical device manufacturer, appointing a U.S. Agent and FDA Official Correspondent is not optional—it is a regulatory requirement for entering and maintaining access to the U.S. market.

RQMIS provides reliable, responsive representation to ensure your organization stays compliant, connected, and prepared for FDA interaction at every stage.

Why This Role Matters

Before you can legally market medical devices in the United States, your establishment must:

Register with the FDA
List your devices
Designate a U.S. Agent

Without a U.S. Agent, your registration cannot be completed—and your products cannot be imported into the U.S.

At the same time, every registered establishment must assign an Official Correspondent responsible for managing FDA communications and maintaining registration accuracy.

Together, these roles ensure that the FDA has a reliable, responsive point of contact for your organization.

What Is a U.S. Agent?

A U.S. Agent is your FDA-designated representative based in the United States.

This role is required for all foreign manufacturers and serves as the primary communication bridge between your company and the FDA.

Key Responsibilities Include:

Facilitating communication between FDA and your organization
Responding to FDA inquiries regarding your devices
Assisting with scheduling FDA inspections
Receiving official FDA communications when direct contact is not possible

The U.S. Agent must:

Maintain a physical presence in the U.S.
Be reachable during normal business hours
Formally confirm their role through the FDA registration system

What Is an FDA Official Correspondent?

The Official Correspondent (OC) is responsible for managing your establishment registration and device listings with the FDA.

Key Responsibilities Include:

Maintaining and updating FDA registration and device listings
Ensuring accuracy of submitted information
Receiving and routing FDA communications
Managing annual registration updates

The OC plays a critical role in ensuring your regulatory information is accurate, current, and inspection-ready.

U.S. Agent vs. Official Correspondent

While these roles often overlap, they serve distinct functions:

U.S. Agent → External FDA communication and inspection support
Official Correspondent → Registration management and internal coordination

In many cases, companies choose a single partner to fulfill both roles—streamlining communication and reducing risk.

The Risk of Getting It Wrong

An unresponsive or poorly managed U.S. Agent or Official Correspondent can lead to:

Missed FDA communications
Delays in inspection scheduling
Import holds or regulatory inquiries
Increased compliance risk

In high-stakes situations—such as warning letters or inspections—timely communication is critical.

How RQMIS Supports You

RQMIS provides dependable U.S. Agent and Official Correspondent services designed to keep your organization compliant and responsive.

Responsive FDA Communication Management

We act as your dedicated point of contact for FDA inquiries, ensuring all communications are received, reviewed, and routed without delay.

Registration & Listing Support: We manage and maintain your FDA establishment registration and device listings, ensuring accuracy and compliance year-round.
Inspection Coordination: We support FDA inspection scheduling and communication, helping you stay prepared and aligned throughout the process.
Ongoing Compliance Support: We ensure your contact information, registrations, and regulatory obligations remain current—so you avoid disruptions to market access.

The Outcome

With RQMIS, you can:

Maintain uninterrupted access to the U.S. market
Ensure timely response to FDA communications
Reduce regulatory risk and compliance gaps
Focus on your core business while we manage the interface with FDA

Your FDA Connection—Handled Right

When it comes to FDA communication, speed and accuracy matter.