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FDA eSTAR & eCopy Submission Formatting Services – XPRO AMERICA

Submitting medical device applications to the U.S. FDA requires not only accurate regulatory content but also the correct submission format. The FDA now strongly encourages the use of eSTAR (Electronic Submission Template And Resource) for 510(k) and De Novo submissions, while eCopy remains the standard for PMA and certain other [...]

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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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