Search for:
  • Home/
    • Tag: FDA market access

Infant Formula & Baby Foods FDA Compliance – XPRO AMERICA

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 [...]

Tags:
Read More

Device Classification & Regulatory Pathway – XPRO AMERICA

Proper device classification and regulatory pathway determination are essential first steps for marketing medical devices in the United States. The FDA classifies devices as Class I, II, or III, based on risk level, intended use, and regulatory controls. Choosing the correct submission route 510(k), De Novo, or PMA (Premarket Approval)—is [...]

Tags:
Read More