The definition of medical devices, according to the Federal Food, Drug, and Cosmetic Act, is as follows:
"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."
Further, a device "does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals, and is not dependent upon being metabolized for the achievement of any of its principal intended purposes."
http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047117.htm
Needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, certain diagnostic test kits, and dental appliances are all examples of medical devices.
Medical devices used in veterinary medicine do not require submission of a 510(k) or formal pre-market approval from the FDA. 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. 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.
It is the responsibility of the manufacturer and/or distributor of veterinary medical devices to assure the safety, efficacy, and proper labeling of these products. In addition, manufacturers of radiation-emitting devices need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH). Manufacturers who exclusively manufacture devices, or distribute veterinary devices are not required to register their establishments and list veterinary devices.
Research by Diane Meade
