Veterinary medical devices are regulated similarly to human medical devices, with the FDA providing guidance to ensure safety, efficacy, and regulatory compliance for animal health products. Manufacturers, importers, and distributors must comply with device registration, product listing, labeling, and safety reporting requirements to legally market veterinary devices in the United States.

At XPRO AMERICA, we offer comprehensive support for veterinary medical device companies, providing regulatory guidance and ensuring seamless compliance with FDA standards.

Key Services:

• Registration & Listing: All facilities manufacturing, repackaging, or distributing veterinary devices must register with the FDA and list each product. XPRO AMERICA manages the registration and product listing process, ensuring timely and accurate submissions.
• Labeling Compliance: Proper labeling is critical to meet FDA requirements and ensure user safety. Our team reviews device labels for clarity, warnings, instructions for use (IFU), and compliance with FDA regulations for veterinary products.
• Safety Reporting: Veterinary devices require monitoring for adverse events and safety issues. XPRO AMERICA assists in preparing and submitting required FDA safety reports, ensuring timely communication and compliance.
• Regulatory Strategy & Guidance: We help companies determine the appropriate regulatory pathway, assess device classification, and maintain ongoing compliance with changing FDA guidelines.

Why Choose XPRO AMERICA?

• Expertise in FDA veterinary device regulations and compliance pathways.
• End-to-end support from facility registration to labeling and safety reporting.
• Preparation for FDA inspections and post-market compliance obligations.
• Minimizes regulatory risk and ensures efficient market entry for veterinary devices.

By partnering with XPRO AMERICA, veterinary device manufacturers and distributors can confidently navigate FDA regulatory requirements. Our services ensure proper registration, accurate labeling, and safety reporting, supporting compliance, product integrity, and long-term market access.

XPRO AMERICA assists veterinary device companies with FDA registration, product listing, labeling, and safety reporting for animal health compliance.