US Agent for Medical Devices (12 months)

US Agent for Medical Devices – 12 Months

Foreign medical device establishments exporting or offering medical devices for import into the United States generally must designate a US Agent as part of their FDA establishment registration. The US Agent serves as a point of contact to help facilitate communication between the foreign establishment and the US Food and Drug Administration (FDA).

Cosmetic Compliance Nest offers a 12-month US Agent service for eligible foreign medical device establishments seeking support with this regulatory requirement. Our service helps establish a communication channel with the FDA in accordance with the applicable US Agent responsibilities.

What Is a US Agent for Medical Devices?

A US Agent is an individual or organisation that resides in, or maintains a place of business in, the United States and is designated by a foreign medical device establishment. The foreign establishment provides the agent's details as part of its FDA registration information.

The US Agent helps the FDA communicate with the foreign establishment, responds to relevant questions about devices imported or offered for import into the United States, and assists with scheduling inspections when requested by the FDA.

What Is Included in the 12-Month Service?

• US Agent designation support: Guidance on providing the relevant US Agent information for your foreign establishment's FDA registration.
• FDA communication point of contact: Designated contact support for communications within the scope of the US Agent's regulatory responsibilities.
• Device-related enquiries: Assistance responding to FDA questions concerning your establishment's devices imported or offered for import into the United States.
• Inspection scheduling assistance: Support with coordinating FDA inspection scheduling when requested.
• 12-month service term: US Agent services for the agreed 12-month period, subject to the service agreement and continued designation.
• Registration information coordination: Guidance on ensuring the agent's contact details are provided through the applicable FDA registration process.

Who Needs a US Agent?

This service is intended for foreign medical device establishments that manufacture, prepare, process or otherwise conduct activities covered by applicable FDA establishment registration requirements for devices imported or offered for import into the United States.

• Medical device manufacturers located outside the United States
• Foreign establishments preparing to enter the US medical device market
• Eligible device businesses maintaining an existing FDA registration
• Foreign medical device establishments seeking to appoint or change their US Agent
• Companies needing a US-based contact for relevant FDA communications

Responsibilities of the US Agent

Under FDA requirements, the US Agent's responsibilities are limited to the applicable regulatory role and include:

• Assisting the FDA in communicating with the foreign establishment.
• Responding to questions concerning the establishment's devices imported or offered for import into the United States.
• Assisting the FDA in scheduling inspections of the foreign establishment.
• Receiving information or documents from the FDA when the agency cannot contact the foreign establishment directly or promptly.

The US Agent must meet FDA requirements for a US-based residence or place of business. A post office box or an answering service alone does not satisfy the FDA's requirements.

What Is Not Included in the US Agent Role?

Appointing a US Agent does not transfer all of the foreign establishment's regulatory responsibilities to that agent. The following should be understood separately:

• FDA establishment registration and device listing requirements
• Applicable premarket submission requirements, such as 510(k) or PMA
• Quality management system and device compliance obligations
• Medical Device Reporting (MDR) responsibilities
• Importation, labelling and other applicable regulatory requirements

These obligations remain subject to the applicable regulations and the responsibilities of the relevant parties. US Agent appointment does not itself constitute FDA approval or clearance of a medical device.

Our US Agent Appointment Process

1. Initial enquiry: Share your company name, country, device information and current FDA registration status, if available.
2. Information review: We review the details needed to assess the service request and applicable appointment requirements.
3. Service confirmation: The appointment and 12-month service term are confirmed under the agreed service terms.
4. FDA designation: The relevant US Agent details are provided through the applicable FDA registration process.
5. Confirmation and communication: The US Agent completes the required consent or verification process, and the appointment is handled in accordance with FDA procedures.

Information Required to Get Started

• Legal name of the foreign establishment
• Company address and country of operation
• Primary contact name, email address and telephone number
• Brief description of the medical devices
• FDA establishment registration details, if already registered
• Details of any current US Agent, if you are requesting a change

Frequently Asked Questions

For further information about the service term, appointment process, required information and scope of support, please visit our dedicated FAQ page or contact Cosmetic Compliance Nest.

Arrange Your US Agent Service

Preparing to register your foreign medical device establishment with the FDA or looking to update your existing US Agent? Contact Cosmetic Compliance Nest to discuss your requirements and arrange the 12-month service.