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.