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Foreign companies manufacturing, repackaging, relabeling, or importing FDA-regulated products into the United States are required to appoint a U.S. Agent. The U.S. Agent serves as the official liaison between the company and the FDA, ensuring that regulatory communications, inspection notices, and emergency matters are handled efficiently and accurately. At XPRO [...]
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 [...]
XPRO America provides expert services for USFDA Agent Registration, a mandatory requirement for foreign facilities exporting FDA-regulated products to the United States. The process can be complex, involving compliance with FDA guidelines and timely submission of accurate details. Our team simplifies the process, acting as your reliable U.S. Agent to handle [...]