Which agency regulates in-house rapid Canine Heartworm antigen test kits used by a veterinary clinic?

• A. FDA CVM
• B. USDA CVB
• C. USDA AMS
• D. FDA FSAN

Answer: (B)

The key idea here is who regulates diagnostic tools used in veterinary practice. In-house rapid heartworm antigen tests are diagnostic kits used to identify disease in dogs and are considered veterinary biologics or in vitro diagnostic reagents intended for animal health. The USDA Center for Veterinary Biologics (CVB) oversees the licensing, production, and distribution of veterinary biologics and diagnostic reagents used to diagnose diseases in animals. Because these heartworm test kits fall under that category, they fall under CVB’s regulatory authority.

The FDA handles many aspects of veterinary medicine and devices, but for veterinary diagnostic reagents and in-clinic tests that are specifically treated as veterinary biologics or diagnostic kits, the governing oversight is through the USDA CVB.