Veterinary Medical Devices
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.”
Unlike human medicine, veterinary medical devices are not subject to a formal approval process. Refer to the link below for additional information.
Examples of Veterinary Medical Equipment
Digital Radiography Units
CT and MRI
Other Examples of Veterinary Devices
Veterinary bioscaffolds - acellular
Tissue repair gels
IOLs and glaucoma shunts
Veterinary Regulatory Links
In veterinary medicine, medical devices are regulated under the purview of the Food and Drug Administration's Center for Veterinary Medicine. Veterinary medical devices do not require submission of a Premarket Approval (PMA) or 510k.