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.
Questions and Answers
Does the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) apply to the use of medical devices in animals?
No. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), which created an exception allowing the extra-label use of approved drugs in specific circumstances, is not relevant to the use of medical devices in animals. Although Federal Food, Drug, and Cosmetic Act (FD&C Act) section 512(a) contains restrictions on “any particular use or intended use” of a new animal drug, there is no similar generally-applicable provision that restricts the “use” of animal devices.
Is it legal for a veterinarian to use a medical device in a manner other than as labeled (i.e. “off-label” use, such as using a human medical device in animals, or using a device for animals in a manner other than as labeled?)
Generally, yes. Although FDA has regulatory authority over animal medical devices, FDA generally does not regulate the manner in which veterinarians use legally marketed devices in animals within the scope of their practice of veterinary medicine. FD&C Act section 1006 states that nothing in the FD&C Act “shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”
However, it is not permissible to use a medical device in an off-label manner if it causes some other violation of the FD&C Act. For example, off-label use of a medical device in a food-producing animal that causes food derived from the animal to be adulterated would still be a violation of the FD&C Act’s requirements for food.
We encourage veterinarians to consider off-label use of devices carefully, especially if such use is specifically contraindicated by the device’s label. We also remind veterinarians that, as FDA does not approve animal medical devices, device labeling may not be as well-developed as approved animal drug labeling.