Veterinary Medical Devices
Medical Devices in Veterinary Medicine: Veterinary medical devices (also referred to as animal 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.” 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, ….) among other products that meet the regulatory definition of a veterinary medical device.
Regulatory Oversight in Veterinary Medicine: The FDA-Center for Veterinary Medicine (FDA-CVM) has regulatory oversight of animal medical devices (e.g., veterinary medical devices). Contrary to regulatory approval requirements for human medical devices , veterinary medical devices are not subject to a formal approval process (FDA-CVM webpage on Animal Medical Devices). Medical devices intended for use in veterinary patients do not require submission of a Premarket Approval (PMA) or 510k. However, the FDA does have regulatory oversight 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.
Veterinary Drug or Veterinary Medical Device? periodically, there may be uncertainty if a product is considered an animal medical device or new animal drug. 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. Our veterinary consultants have assisted numerous companies in helping to establish the product’s designation with the Center for Veterinary Medicine.
- Imaging equipment and devices
- Veterinary biomaterials / bioscaffolds
- Viscoelastic injections
- Surgical equipment, syringes, etc.
- Implants and prosthetics
- Dental appliances
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.
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.
Bioscaffolds and Biomaterials
(e.g., accellular tissue derivatives, viscoelastics, hydrogels, synthetic materials)
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 as veterinary medical devices in veterinary medicine. Our veterinary consultants have helped to develop and commercialize ACTPs as well as acellular veterinary bioscaffolds and veterinary biomaterials for companion animal use.