U.S. Agent, Importer, Initial Importer: Who Does What at FDA and the U.S. Border?

To operate a compliant supply chain, you must distinguish between these three distinct roles. Each has a specific function in FDA’s ecosystem, and assigning them to the wrong partner creates liability gaps.

1. The U.S. Agent

The Role: This is your regulatory liaison. Every foreign establishment must appoint one. They are the primary point of contact for FDA to schedule inspections or ask questions about your device listings.
The Liability: They do not take physical possession of goods. Their liability is focused on communication responsiveness and paying inspection fees if you refuse an audit.
Who should do it? A professional regulatory firm (like BRS LLC) that understands how to triage FDA communications.

2. The Initial Importer

The Role: This is the U.S.-based entity that physically receives your goods from overseas. They are the "boots on the ground" for compliance.
The Liability: They are responsible for reporting adverse events (MDRs) and Corrections/Removals to FDA. They must maintain a compliant complaint handling system.
Who should do it? Your U.S. distributor or a dedicated logistics partner registered with FDA.

3. The Importer of Record (Customs)

The Role: This is primarily a financial and logistical role defined by U.S. Customs and Border Protection (CBP). They pay the duties and tariffs.
The Confusion: Often, the "Initial Importer" (FDA role) and "Importer of Record" (Customs role) are the same company, but they don't have to be. However, if your Customs paperwork lists an Importer who is not registered with FDA, your shipment will likely be held.