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Investigational Device Exemption (IDE) Guidance – XPRO AMERICA

An Investigational Device Exemption (IDE) allows medical device manufacturers to conduct clinical trials in the United States using investigational devices that have not yet received FDA clearance or approval. IDE submissions enable the collection of safety and effectiveness data essential for regulatory pathways such as 510(k), De Novo, or PMA. [...]

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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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