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Special & Abbreviated 510(k) Pathways Support – XPRO AMERICA

The U.S. FDA provides multiple 510(k) pathways to streamline medical device clearance, including the Special 510(k) and Abbreviated 510(k) routes. Selecting the correct pathway is essential for efficient review, regulatory compliance, and avoiding unnecessary delays or additional testing. At XPRO AMERICA, we specialize in guiding manufacturers through these specialized pathways, [...]

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FDA Clearance & Post-Market Setup Services – XPRO AMERICA

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 [...]

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