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US FDA Agent Representation

The FDA requires foreign companies that want to market a medical device in the United States (US) to designate a US-based agent.

The US Agent:

  • Helps the FDA communicate with the foreign company and schedule inspections.
  • Responds to questions about the foreign company’s products.
  • Receives information or documents from the FDA on behalf of the foreign company (when the FDA is unable to contact the foreign company directly or in a timely manner).
  • It’s critical that your US Agent understands FDA regulatory requirements and has experience communicating with the Agency.

We have worked with the FDA since 1977, and our experience includes new product approvals for medical devices, regulatory assurance, and compliance.

You can find a US Agent with the necessary knowledge and skills at
Oriel STAT A MATRIX.

In addition to providing US Agent services, Oriel STAT A MATRIX can help your company:

  • Communicate with the FDA.
  • Register with the FDA.
  • List your exempt and 510(k)-cleared medical devices
  • Update your required Establishment Registration and device listing
  • Identify any registration exemptions.
  • Determine if FDA Medical Device User Fees are required for your registration. If so, we will help you prepare and submit your payment.
  • Help you to obtain a Certificate of Foreign Government (CFG) from the FDA if your company wants to confirm it has a current, valid FDA Registration.
  • Submit and maintain your device listing with the FDA.

Oriel STAT A MATRIX also provides a full range of medical device regulatory and quality assurance training and consulting. Medical device companies around the world use our services to achieve compliance with FDA and international regulations.

Our team is here to help. Call 1.888.532.6360 or contact us online ›