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After successfully navigating the 510(k) or De Novo submission process, medical device manufacturers must secure their FDA clearance certificate and ensure ongoing compliance with post-market requirements. Timely clearance and accurate post-market setup are essential for legal distribution and long-term regulatory success in the U.S. market. At XPRO AMERICA, we provide [...]
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 [...]
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 [...]