Veterinary Devices
The FDA has regulatory oversight over veterinary medical devices and, as such, can take appropriate regulatory action should a veterinary device be misbranded, mislabeled, or adulterated.
The Federal Food, Drug, and Cosmetic Act defines a veterinary device as “an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory thereof, which is intended for use in the diagnosis of disease or other conditions; 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.”[1]
The FDA does not require submission of a 510(k) or formal pre-market approval for devices used in veterinary medicine. Firms that manufacture radiation emitting devices need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health. The FDA does recommend, however, that devices should meet or be equivalent to performance standards, especially important for devices that can be used in both humans and animals (e.g., examination gloves, sterile catheters, infusion pumps, etc.). Additionally, to ensure compliance with labeling and regulations, the FDA recommends that manufacturers and/or distributors of veterinary medical devices request a review of their product labeling and promotional literature.[1]
Manufacturers who exclusively manufacture devices, or distribute veterinary devices are not required to register their establishments and list veterinary devices.
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