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Medical Device Import Compliance & Customs Support – XPRO AMERICA

Ensuring FDA import compliance is essential for foreign medical device manufacturers and U.S. importers to avoid detention, refusal, or penalties at U.S. ports. The FDA enforces strict regulations on medical devices entering the U.S., including establishment registration, device listing, labeling, and prior notice requirements. At XPRO AMERICA, we provide comprehensive [...]

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510(k) Premarket Notification & Clearance Support – XPRO AMERICA

The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States. At [...]

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