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FDA US Agent Representation

Navigating Complex FDA Regulations for Foreign Medical Device Companies

According to the Food and Drug Administration’s (FDA) Modernization Act of 1997, a company that manufactures, prepares, propagates, compounds, or processes a drug or device imported into the United States must identify a US agent on its behalf. For devices in particular, each foreign establishment may designate a US agent who is either a resident of or maintains a place of business in the US. If you’re not sure where to start, AlvaMed can help.

As a registered US Agent with the FDA, AlvaMed will serve as a liaison between your organization and the FDA, and provide ongoing communication support that includes:

  • Answering FDA questions or responding to issues regarding your products
  • Assisting the FDA in scheduling inspections
  • Registering your device(s) and company with the FDA
  • Completing your registration with the FDA via the electronic Registration and Listing System, if requested
  • Providing additional support as required by the FDA, if needed


As a professional regulatory firm, AlvaMed has a long history serving as a US agent for foreign establishments. We will represent your company’s best interests while ensuring compliance with FDA regulations.

With AlvaMed as your US agent, you can focus on your core business activities while we handle the complexities of FDA compliance.

AlvaMed provided a cost-effective approach to meeting the client’s regulatory requirements for US Agent service. As the company grew, they opened their own US subsidiary to serve as their in-house sales and distribution office. AlvaMed smoothly transitioned US Agent responsibilities to the US subsidiary once the client was ready. 

FDA US Agent Case Study

Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.

President

MedTech Client

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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We look forward to discussing AlvaMed’s services with you.

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FDA US Agent Representation FAQ's

Look for expertise in several areas:

  • Deep understanding of the FDA regulatory landscape: Experience with your specific device type is a bonus.
  • Proven track record representing international companies: They should know the nuances of cross-border interactions.
  • Strong communication and interpersonal skills: Effective liaison between your company and the FDA.
  • Familiarity with your company culture and goals: Ensuring alignment and efficient collaboration.

At AlvaMed we have expertise across a broad range of medical devices.

AlvaMed charges an annual fee and then charges hourly for support. The total fees vary depending on the following factors:

  • The complexity of your device and its regulatory pathway.
  • The level of ongoing support you require (e.g., regulatory filings, inspections, post-market activities).


AlvaMed supports clients across the entire spectrum of quality, regulatory and clinical compliance.

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
 

Eric Bannon

Senior Vice President of Regulatory and Clinical Affairs

Eric leads the regulatory practice at AlvaMed and can add your company to those we currently support as a designated US Agent.

Schedule a meeting with Eric to learn more about AlvaMed’s US Agent Services and how we can help you successfully enter the US market.

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  • Mailbox: 935 Great Plain Ave, Suite 166 • Needham, MA 02492
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