FDA Agent Program
The Food and Drug Administration (FDA) requires that all medical devices, including eyeglass frames, lenses and sunglasses, imported into the United States have a designated U.S. Agent listed with the FDA.
The Vision Council's FDA Agent program provides members of the optical industry with dedicated FDA Agent services, keeping you up to date with current regulations and immediately informing you of any changes that could impact your company. With unparalleled knowledge of the optical marketplace, The Vision Council serves as the most reliable choice for your company's FDA Agent at a fraction of what others charge for this program.
As your FDA Agent, we:
- Ensure that you are up to date with current regulations and immediately inform you of changes that could impact your company
- Assist the FDA with communications to your company
- Respond to the FDA's questions concerning your imported products/devices
- Assist the FDA in scheduling inspections of the foreign establishment
- Charge a fraction of what many companies charge for this program because of our unique optical product focus
The Vision Council offers FDA Agent services on an annual basis to more than 125 international optical device manufacturers. Our fee for one year of service is $500, with a one-time application fee of $100.
Questions? Contact Lisa Wright for more information or to get started.