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FDA Agents

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U.S. Agent and Registration of Facilities Worldwide
for the United States Food and Drug Administration

Sunglasses, Frames, Lens and Magnifying Spectacles

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Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices that are required to be listed with US FDA and the company must register with US FDA.

We at FDA Agents can take care of all these requirements for you, with our expert registration, device listing and US Agent service.

Among the FDA regulations that apply are:

* U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA;

** foreign manufacturers must register their establishment with FDA and name a United States Agent;

*** manufacturers must list their device with FDA.

****the lens for spectacles and/or sunglasses must be certified as impact resistant.

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If your products are sunglasses, frames, lens or spectacles, the required ESTABLISHMENT REGISTRATION and MEDICAL DEVICE LISTING can be completed here. To start the process and complete the registration and listing forms, just click "REGISTER MEDICAL" here or in the menu above.