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

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

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About Sterling Medical Devices 

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

Resources

3D printing of organ next to computer screen

June 29, 2022

3D Printing of Medical Devices at the Point of Care

FDA Action on 3D Printing of Medical Devices at the Point of Care In the medical device field, manufacturers and regulators are constantly trying to balance the advantages of new and emerging...
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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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