US Agent & Device Listing

Core Service

U.S. Agent & Device Listing

U.S. Agent coverage + listing accuracy controls designed to prevent import holds and renewal failures.

For foreign manufacturers, the U.S. Agent role is not just a formality—it is your critical link to the FDA. We serve as your official U.S. Agent and manage your device listings end-to-end, keeping your compliance posture defensible and aligned with your commercial plans.

U.S. Agent and FDA Compliance
Concepts Details RACI Pricing FAQs Request Consult
Definitions
FDA U.S. Agent

A mandatory U.S.-based representative for foreign establishments. FDA uses this contact for routine inquiries, shipment questions, and inspection scheduling.

Device Listing

The official FDA record tying your devices to your establishment. This data is leveraged daily for U.S. Customs screening and FDA database checks.

Who Needs This?

  • • Foreign manufacturers entering the U.S. market.
  • • Established manufacturers expanding portfolios.
  • • Distributors needing upstream assurance.

Our Role

  • • Act as official U.S. Agent in FURLS.
  • • Receive and triage FDA correspondence.
  • • Maintain an audit-ready record.

Portfolio Control

  • ✓ Product Codes
  • ✓ 510(k) Alignment
  • ✓ Retire Obsolete
  • ✓ Traceable History

Roles & Responsibilities (RACI)

Clear accountability for every step of the process.

AreaYour TeamBRS LLC
Strategy Define target markets and portfolio. Translate inputs into a registration plan.
Technical Data Provide specs and labeling. Map to product codes and regulations.
FDA Comms Review and approve responses. Receive inquiries; draft and submit.
Maintenance Notify us of changes. Execute updates with traceability.

Coverage Tiers

Lifecycle support tiers tailored to your compliance complexity.

Essential Coverage

Baseline compliance for stable portfolios.

Annual / Site
  • ✓ U.S. Agent of Record
  • ✓ Device Listing Maintenance
  • ✓ Annual Renewal Calendar
  • ✓ Basic Correspondence Triage
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Portfolio Governance

High-touch coverage with active validation controls.

Monthly / Access
  • ✓ Everything in Essential
  • ✓ Pre-submission Validation
  • ✓ Change Control Management
  • ✓ Quarterly Data Review
Inquire for Rates

Enterprise Coverage

Dedicated escalation and importer support.

Custom / Scope
  • ✓ Everything in Governance
  • ✓ Defined Response SLAs
  • ✓ Importer Strategy Support
  • ✓ Detention Triage Playbook
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What Can Go Wrong?

Common failure modes we prevent:

  • ⚠ Wrong product code mapping → Import friction.
  • ⚠ Obsolete listings → Inspection confusion.
  • ⚠ Weak Agent responsiveness → Delayed FDA comms.

What BRS Controls

We replace reactive scrambling with validation, traceability, and a strict response cadence. Your data is verified before submission.

Ready to stabilize your FDA presence?

Ensure your U.S. Agent and listings support your commercial strategy—without the administrative noise.

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Frequently Asked Questions

What is the U.S. Agent's primary responsibility?
The U.S. Agent serves as a communication bridge between the FDA and a foreign establishment. They must be available to answer FDA queries during business hours and assist with inspection logistics.
Who pays the FDA annual registration fee?
The establishment itself is responsible for the fee. You pay FDA directly; BRS LLC facilitates the process but does not collect this government fee.
What happens if a shipment is detained?
Speed is critical. As your U.S. Agent, we triage immediately, document actions, and drive an escalation path to determine if it is a clerical error or a compliance flag.