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Successful FDA 510(k) submissions require not only a complete dossier but also effective communication with the FDA throughout the review process. Misunderstandings, incomplete responses, or delays in addressing Additional Information (AI) requests can prolong approval timelines and create regulatory risk. At XPRO AMERICA, we provide end-to-end support for FDA communication [...]
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 De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain FDA marketing authorization by demonstrating safety and effectiveness while establishing a new device classification. At XPRO AMERICA, we provide expert [...]