Accurate and FDA-compliant labeling is essential for the safe use, marketing, and distribution of medical devices in the United States. Under 21 CFR Part 801, the FDA sets strict requirements for device labels and Instructions for Use (IFU), ensuring that healthcare providers and patients clearly understand product applications, limitations, and safety precautions. Failure to comply with these requirements can lead to misbranding, product recalls, or reclassification into a higher-risk regulatory category.

At XPRO AMERICA, we specialize in medical device labeling compliance and IFU development, guiding manufacturers through FDA requirements to ensure accuracy, clarity, and regulatory alignment.

Key Components of FDA-Compliant Labeling & IFU:

• Label Content (21 CFR Part 801): Labels must include product name, intended use, directions for use, warnings, contraindications, lot/batch number, and manufacturer details. We help ensure every required element is present and correctly formatted.
• Claims Review & Risk of Reclassification: Marketing claims are carefully reviewed to avoid language that could reclassify the device as a drug or higher-risk product. For example, stating “treats or cures disease” could shift a device into drug classification. XPRO AMERICA ensures that claims remain compliant while maintaining strong market positioning.
• UDI (Unique Device Identification): FDA requires most devices to carry a UDI system for traceability and post-market safety monitoring. We provide guidance on UDI assignment, labeling integration, and database submissions (GUDID).
• Instructions for Use (IFU): IFUs must be user-friendly, scientifically accurate, and aligned with regulatory expectations. They should include setup, operation, maintenance, troubleshooting, and safety information to reduce misuse risks.

Why Choose XPRO AMERICA?

• Expertise in FDA device labeling and IFU compliance.
• Detailed claim review to prevent misbranding or reclassification.
• Step-by-step guidance on UDI labeling and GUDID compliance.
• Streamlined documentation support for faster FDA clearance.

Proper labeling and IFU are not just regulatory requirements—they are vital to patient safety and market success. With XPRO AMERICA’s labeling compliance services, manufacturers gain confidence that their devices meet FDA standards and avoid costly delays or enforcement actions.

XPRO AMERICA ensures FDA-compliant device labeling, IFU review, and UDI guidance to meet 21 CFR Part 801 requirements for safe U.S. market entry.