Veterinary Medical Devices

The FDA-Center for Veterinary Medicine (FDA-CVM) has oversight of animal devices (e.g., veterinary medical devices), but does not require a formal approval process.  In animal health, veterinarians use a variety of medical devices for surgery (bone plates, screws, prosthetics…..), imaging (ultrasound, lasers, …) and woundcare (dressings, wound care gels, ….).  In certain situations, the designation device vs drug may be ambiguous in veterinary medicine.  However, if a product is already designated as a device for humans and/or has a 510k or PMA, it may support the designation as a medical device for veterinary medicine.  Firms should refer to the definition of device vs drug, as follows:

Veterinary medical devices are products which are “…..intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or [which is] intended to affect the structure or any function of the body of man or other animals …”, and which “does not achieve its primary intended purposes through chemical action within or on the body ……, and … is not dependent upon being metabolized for the achievement of its primary intended purposes.”

• Imaging equipment and devices
• Veterinary biomaterials / bioscaffolds
• Viscoelastic injections
• Surgical equipment, syringes, etc.
• Implants and prosthetics
• Dental appliances

Regulations: Contrary to medical devices for human use, veterinary medical devices are not subject to a formal approval process.  In veterinary medicine, medical devices are regulated under the purview of the Food and Drug Administration’s Center for Veterinary Medicine.  Devices intended for use in veterinary patients do not require submission of a Premarket Approval (PMA) or 510k.

Veterinary Diagnostics: In vitro diagnostics are often classified as medical devices on the human side.  In veterinary medicine, however, animal in vitro diagnostics may be regulated by the United States Department of Agriculture as “diagnostic kits”.  Please refer to our veterinary diagnostics page for more information about how animal diagnostics are regulated in veterinary medicine.

Devices used in veterinary medicine do not require US FDA approval for their use.  However, the FDA does have regulatory oversight over veterinary devices, and manufacturers or distributors are responsible for making sure these products are safe, effective, and properly labeled.  Prior to selling or distributing devices for animal use, the FDA-Center for Veterinary Medicine (FDA-CVM) recommends that manufacturers submit labels and promotional materials.

NOTE:

• Firms that manufacture radiation emitting devices used in veterinary medicine must register these products with the Center for Devices Radiological Health (CDRH).
• Companies that exclusively manufacture or distribute veterinary devices are not required to register their establishments.

Acellular bioscaffolds (e.g., veterinary bioscaffolds which do not contain a cells or cell byproducts), such as bone putty, decellularized tissues, or scaffolds comprised of the extracellular matrix (ECM) are routinely distributed and sold a medical devices in veterinary medicine.  However,  cellular and acellular combination products would likely be regulated as a drug under FDA-CVM’s.  Our veterinary consultants have helped to develop and commercialize acellular veterinary bioscaffolds and veterinary biomaterials for companion animal use.