US Agent Services (FDA Official Correspondent)

For Medical Device and In Vitro Diagnostics (IVD) companies without a physical presence in the United States (U.S.), appointing an FDA-registered U.S. Agent is not just a regulatory requirement—it’s a critical step for accessing the U.S. market. At RQMIS, we serve as your FDA U.S. Agent (Official Correspondent), providing reliable representation and ensuring compliance with FDA requirements.

Registration requirements apply to the following categories of foreign establishments:

Primary Manufacturers
Contract Manufacturers and Remanufacturers
Contract Sterilizers
Foreign Exporter of medical devices located in a non-US country
Specification Developers/Reprocessors of single-use medical devices

Why Do You Need an FDA U.S. Agent?

The U.S. Food and Drug Administration (FDA) requires all foreign medical device and IVD companies to appoint a registered U.S. Agent who:

Is physically located in the U.S. or maintains a physical place of business within the country.
Is available during U.S. business hours to respond to FDA communications, including inspections, queries, and urgent matters.
Acts as a liaison between the FDA and the foreign establishment, ensuring timely and accurate communication.

How RQMIS Supports You as an FDA U.S. Agent

1. FDA Establishment Registration Assistance

Guide you through the FDA Unified Registration and Listing System (FURLS) for establishment registration and device listing.
Ensure compliance with annual registration renewal requirements and timely payment of FDA registration fees.
Maintain accurate establishment information in FDA databases.

2. Official Communication with the FDA

Serve as your primary point of contact with the FDA for all official correspondence.
Facilitate FDA inspections, audits, and inquiries efficiently and professionally.
Ensure prompt responses to FDA regulatory notices, including 483 observations, Warning Letters, or recalls.

3. Representation During FDA Inspections

Provide support and guidance during FDA inspections of foreign establishments.
Assist in preparing documentation and ensuring all processes meet FDA compliance standards.
Help address any findings or corrective actions required post-inspection.

4. Regulatory Compliance Support

Assist in meeting FDA compliance requirements across all regulatory categories, including labeling, quality management systems, and device safety.
Offer risk management strategies to prevent compliance gaps and streamline operations.

5. Ongoing Updates and Guidance

Keep you informed of regulatory updates affecting your device category and establishment requirements.
Provide regular compliance health checks to ensure continued alignment with FDA standards.

Who Needs an FDA U.S. Agent?

The FDA U.S. Agent requirement applies to the following categories of foreign establishments:

Primary Manufacturers: Companies primarily responsible for designing, producing, or assembling medical devices.
Contract Manufacturers and Remanufacturers: Companies producing devices under a contract or reprocessing previously used devices.
Contract Sterilizers: Facilities providing sterilization services for medical devices.
Foreign Exporters: Companies located outside the U.S. that export medical devices into the U.S. market.
Specification Developers: Entities responsible for defining the specifications and requirements for medical devices.
Reprocessors of Single-Use Devices: Companies authorized to clean, test, and reuse single-use medical devices.

Why Choose RQMIS as Your FDA U.S. Agent?

Decades of Industry Expertise: Deep knowledge of FDA regulations, medical device quality systems, and compliance protocols.
Responsive and Reliable Communication: Always available during U.S. business hours to handle critical communications.
Comprehensive Support: From registration and inspections to ongoing compliance, we offer end-to-end services.
Customized Solutions: Tailored strategies to meet the unique needs of your establishment and product category.
Proactive Compliance Monitoring: We stay ahead of regulatory changes, ensuring continuous compliance.

FDA Medical Device User Fee Rates for Fiscal Year 2025

Federal law authorizes the U.S. Food and Drug Administration (FDA) to collect user fees/costs for certain medical device submissions and establishment registration. On October 7, 2024, the FDA announced the FY2025 user fees/prices for FDA Medical Device User Fees for 2025 in Medical Device User Fee Rates for Fiscal Year 2025. User fees are required for the following types of medical device submissions:

FDA premarket notifications (510(k)s)
FDA premarket approval applications (PMAs)
product development protocols (PDPs)
FDA De Novo classification requests
some PMA and PDP supplements (for example, panel-track, 180-day, real-time, 30-day notice)
premarket reports (PMRs)
the annual fee for periodic reporting on a class III medical device (PMAs, PDPs, and PMRs)
requests for medical device classification information (513(g)s)
original biologics license applications (BLAs) for certain medical devices reviewed by the FDA's Center for Biologics Evaluation and Research (CBER)
BLA efficacy supplements

In addition, all medical device establishments are required to pay an annual establishment registration fee. Below is the price listed.

FY2025 User Fee for Establishment Registration

For FY2025, the registration fee/cost for each establishment registration is $9,280 (in United States dollars). There are no waivers or reductions for small establishments, businesses, or group registration on the fees.

The annual establishment registration fee must be paid between October 1, 2024, and December 31, 2024.