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Veterinary medical devices are regulated similarly to human medical devices, with the FDA providing guidance to ensure safety, efficacy, and regulatory compliance for animal health products. Manufacturers, importers, and distributors must comply with device registration, product listing, labeling, and safety reporting requirements to legally market veterinary devices in the United [...]
Achieving U.S. FDA compliance is only the first step maintaining it requires constant attention. FDA regulations are dynamic, with frequent updates to labeling rules, safety standards, registration requirements, and inspection protocols. Businesses that fail to keep up with these changes risk losing market access, facing enforcement actions, or damaging their [...]
Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report adverse events and product problems to the FDA. Compliance with MDR regulations ensures patient safety, reduces liability, and supports timely FDA oversight. At XPRO AMERICA, we provide end-to-end support for implementing a [...]
For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities must renew their establishment registration and update product listings to remain in good standing with the FDA. In addition, regulatory [...]
Ensuring consumer safety is at the core of FDA regulations, and one of the most critical obligations for companies in the food, dietary supplement, cosmetic, and OTC product industries is adverse event and safety reporting. The FDA requires manufacturers, packers, distributors, and importers to maintain systems for documenting and reporting [...]