A US Agent for FDA compliance is a person or entity based in the United States designated by a foreign manufacturer to act as its local liaison with the Food and Drug Administration...

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Importing medical devices and certain cosmetic products and devices —such as RF skin-tightening tools, laser tattoo removers, or LED phototherapy panels—into the United States demands more than just logistics.

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Modern medical devices and certain cosmetic “devices” such as RF skin-tightening tools often rely on Bluetooth, Wi-Fi, or cellular connectivity. While the FDA safeguards their safety and efficacy, the Federal Communications Commission (FCC) governs radio frequency (RF) emissions and spectrum use.

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