Veterinary medical devices, also called animal medical devices, are an integral part of the veterinary market. Veterinarians use a variety of medical devices, including those used in surgery (bone plates, screws, prosthetics…..), imaging (ultrasound, lasers, …) and topical wounds (dressings, wound care gels, ….).
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.”
Veterinary Medical Device Regulations: In veterinary medicine, medical devices are regulated under the purview of the Food and Drug Administration’s Center for Veterinary Medicine, however these products are not subject to Premarket Approval (PMA) or 510k (FDA link).
Examples of Veterinary Medical Equipment include ultrasound units, digital radiography units, CT and MRI, anesthesia systems and syringes.
Other Types of Veterinary Medical Devices may include acellular veterinary bioscaffolds, biomaterials and bone polymers. However, these products have come under more scrutiny as many acellular products may achieve the primary mode of action from metabolism or chemical reaction. For instance, the FDA has recently categorized certain hyaluronic acid viscoelastics as “drugs”.
Although not required, the FDA-CVM invites Sponsors to submit their animal medical device labeling to ensure compliance with the Federal Food, Drug and Cosmetic Act. Our veterinary consultants can work with clients with animal medical device labeling including the submitting to FDA-CVM for their review to ensure compliance.
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