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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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De Novo Device Classification & FDA Support – XPRO AMERICA

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 [...]

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