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How FDA Regulates Animal Devices

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.

FDA does have regulatory oversight over devices intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated.

Pre-market Approval is Not Required: The FDA does not require submission of a 510(k), PMA, or any pre-market approval for devices intended for animal use.

Device manufacturers who exclusively manufacture or distribute animal devices are not required to register their establishments or list animal devices with FDA and are exempt from post-marketing reporting. 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.

The FDA encourages veterinarians and animal owners to report adverse drug experiences and product defects associated with animal devices to FDA using Form FDA 1932a.

An animal device that is also a radiation emitting electronic product, such as an MRI device intended for animal use, must comply with all requirements for animal devices in addition to applicable requirements for radiation-emitting electronic products in 21 CFR 1000 - 1050. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products. For further information on CDRH regulations that apply to manufacturers of electronic products, visit FDA’s website on Radiation Emitting Products.

Manufacturers and/or distributors of animal medical devices may request a review of their product labeling and promotional literature to ensure that it complies with the Act by emailing AskCVM@fda.hhs.gov. This includes devices marketed in another country and offered for importation into the U.S.

Additional Information