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Infant formula and baby foods are subject to strict FDA regulations to ensure safety, nutritional adequacy, and labeling accuracy for vulnerable populations. Manufacturers must comply with specialized review requirements, register facilities, and maintain adherence to nutrient content standards before marketing their products in the United States. At XPRO AMERICA, we provide comprehensive guidance [...]
The FDA regulates blood and tissue products to protect public health and ensure safety, efficacy, and quality. Facilities such as blood banks, cord blood banks, and tissue establishments must comply with rigorous regulatory requirements, including registration, donor eligibility screening, labeling, and traceability documentation. At XPRO AMERICA, we provide comprehensive support [...]
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. [...]
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 [...]
Bringing a pharmaceutical product to the U.S. market requires rigorous regulatory approval by the U.S. Food and Drug Administration (FDA). For drug manufacturers, this process involves filing either an Abbreviated New Drug Application (ANDA) for generic drugs or a New Drug Application (NDA) for novel, innovative drugs. The ANDA pathway [...]
XPRO America offers expert assistance for USFDA NDC (National Drug Code) Registration, required for companies manufacturing, repacking, relabeling, or distributing drug products in the United States. The process involves detailed submission of product and label information in compliance with FDA regulations. Our team streamlines this process, ensuring accurate registration and faster approval. Our Services [...]