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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 [...]
The U.S. FDA regulates animal drugs, feed, and veterinary products to ensure the safety, quality, and efficacy of products for animals. Compliance with FDA regulations, including 21 CFR Part 514 and FSMA (Food Safety Modernization Act), is mandatory for manufacturers, distributors, and importers. Proper registration, labeling, and reporting are critical [...]
USFDA FEI Number Registration @XPRO AMERICA – Your Gateway to FDA Compliance For any facility engaged in manufacturing, processing, packing, or storing FDA-regulated products such as food, cosmetics, pharmaceuticals, or medical devices, obtaining a USFDA FEI (Facility Establishment Identifier) Number is a critical compliance requirement. The FEI Number serves as a unique identifier for your facility in [...]