The Federal Food, Drug, and Cosmetic Act (the Act) defines medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... 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 ... ." Further, a device "does not achieve its primary 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 its primary intended purposes." Examples of devices include such things as needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, certain diagnostic test kits, and dental appliances.
Pre-market Approval is Not Required: 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 (CDRH).
Device manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments and list veterinary devices.
FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated.
It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.
FDA recommends that manufacturers and/or distributors of veterinary medical devices request a review of their product labeling and promotional literature to ensure that it complies with the Act. This includes devices marketed in another country and offered for importation into the U.S.