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.
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.
