Registered U.S. Agent

According to the FDA’s 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 U.S. agent on its behalf. For devices in particular, each foreign establishment may designate a U.S. Agent who is either a resident of or maintains a place of business in the U.S. If you’re not sure where to start, we can help!

At Sterling Medical Devices, we will act as your official U.S. Agent. In this role, we will serve as a liaison between your organization and the FDA and provide ongoing communications 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, our team has a long history serving as a U.S. Agent for foreign establishments, we will represent your company’s best interests while ensuring compliance with FDA regulations.

Contact us for more information about how to get started with Sterling’s Registered FDA Agent program.

Resources

July 7, 2015

Should the FDA’s Regulatory Oversight of Medical Device Apps be Limited Any Further?

The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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