FDA U.S. Agent Representation
According to the Food and Drug Administration’s (FDA) 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, Sterling can help.
At Sterling Medical Devices, we will act as your official U.S. agent, serving as a liaison between your organization and the FDA, and provide ongoing communication 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.