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 traceability and patient safety.

At XPRO AMERICA, we provide comprehensive labeling compliance services for medical device manufacturers and importers, ensuring adherence to FDA regulations and minimizing the risk of misbranding or regulatory enforcement.

Key Services:

• Labeling Review: We conduct a detailed review of device labels, including product name, intended use, warnings, instructions for use (IFU), symbols, and storage conditions, ensuring full compliance with FDA requirements.
• UDI Compliance: XPRO AMERICA helps implement the Unique Device Identification system, assigning appropriate Device Identifier (DI) and production identifiers to facilitate device tracking and traceability.
• Claims & Instructions Compliance: We review device claims to ensure they are truthful, non-misleading, and consistent with the intended use. Instructions for use are evaluated to guarantee clarity, accuracy, and adherence to FDA labeling standards.
• Documentation & Regulatory Support: Our team prepares labeling documentation for submission to FDA, maintains records for inspection readiness, and provides guidance for ongoing compliance updates.
• Audit & Inspection Preparedness: We support facilities in preparing for FDA inspections by reviewing labeling practices, documentation, and UDI implementation, reducing compliance risks.

Why Choose XPRO AMERICA?

• Expert knowledge of 21 CFR Part 801 labeling requirements.
• End-to-end support from label review to UDI compliance and FDA documentation.
• Minimizes regulatory risk and ensures accurate, compliant device labeling.
• Prepares companies for FDA audits, inspections, and post-market compliance.

Partnering with XPRO AMERICA ensures medical device manufacturers and importers maintain complete labeling compliance, meet UDI requirements, and effectively communicate device use and safety to end-users. Our services streamline regulatory submissions, enhance traceability, and support successful market access.

XPRO AMERICA ensures FDA labeling compliance, UDI requirements, and review of claims and instructions for medical devices.