FDA labeling compliance

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 [...]

Color Additives & Food Contact Compliance – XPRO AMERICA

The FDA regulates color additives and food contact substances (FCS) to ensure safety for consumers. Companies introducing new color additives or materials intended for contact with food must comply with rigorous FDA requirements, including premarket approval, notifications, and safety testing. At XPRO AMERICA, we provide end-to-end guidance for manufacturers, distributors, [...]

US FDA Labeling Compliance – XPRO AMERICA

Labeling is one of the most important aspects of U.S. FDA compliance for food and beverage products. Any company intending to sell its products in the United States must ensure that packaging and labels meet the strict requirements set forth by the U.S. Food and Drug Administration (FDA). Accurate labeling [...]

Premarket Approval (PMA) Applications for Class III Devices – XPRO AMERICA

Premarket Approval (PMA) is the FDA’s regulatory pathway for high-risk Class III medical devices, which require extensive scientific evidence demonstrating safety and effectiveness before marketing in the United States. Unlike 510(k) or De Novo submissions, PMA applications often involve clinical study data and rigorous review processes. At XPRO AMERICA, we [...]

Medical Device Labeling Compliance & UDI – XPRO AMERICA

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 [...]

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 [...]

510(k) Premarket Notification & Clearance Support – XPRO AMERICA

The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States. At [...]

USFDA Establishment Registration – XPRO America – Food, Drugs, Cosmetic, Medical Devices – Alternative to Registrar Corp

USFDA Registration Services @XPRO AMERICA – Simplifying Your Path to the U.S. Market If your business aims to export food, cosmetics, dietary supplements, or medical devices to the United States, obtaining a USFDA Establishment Registration is a mandatory step. This process ensures your facility is recognized by the U.S. Food and Drug Administration (FDA) and is compliant [...]