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FDA Clinical Data Support & IDE Guidance for Devices – XPRO AMERICA

For many medical devices, bench testing, biocompatibility studies, and performance data may be sufficient to demonstrate safety and effectiveness. However, in certain cases, the FDA requires clinical evidence to support a device’s regulatory submission. Knowing when clinical data is expected and preparing it correctly can be the difference between a [...]

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Premarket Approval (PMA) Applications for Class III Devices – XPRO AMERICA

Premarket Approval (PMA) is the FDA’s regulatory pathway for high-risk Class III medical devices, which require extensive scientific evidence demonstrating safety and effectiveness before marketing in the United States. Unlike 510(k) or De Novo submissions, PMA applications often involve clinical study data and rigorous review processes. At XPRO AMERICA, we [...]

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