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With the rising global demand for U.S. FDA compliance, XPRO America an established provider of USFDA registration and regulatory consulting has taken a bold step forward by launching its services on top freelance platforms: Fiverr and Upwork. Traditionally operating through its website consultancy model, XPRO America specializes in guiding international [...]
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 [...]
The dietary supplements and nutraceuticals industry in the U.S. is highly regulated under 21 CFR Part 111 to ensure product safety, quality, and accurate labeling. Compliance with FDA regulations is mandatory for manufacturers, distributors, and importers, covering facility registration, labeling, Good Manufacturing Practices (GMP), and reporting new dietary ingredients (NDIs). [...]
Accurate and compliant device labeling is critical to ensure safety, regulatory adherence, and market access in the United States. Under 21 CFR Part 801, the FDA requires medical devices to have labels that clearly communicate intended use, instructions, and risk information. Compliance with Unique Device Identification (UDI) regulations further enhances [...]
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 [...]