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U.S. Department of Health and Human Services

Animal & Veterinary

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How FDA Regulates Veterinary Devices

FDA Veterinarian Newsletter May/June 2003 Volume XVIII, No 3

FDA has regulatory oversight over veterinary medical devices1 and can take appropriate regulatory action if a veterinary device is misbranded, mislabeled, or adulterated.

FDA does not require submission of a 510(k) or formal pre-market approval for devices used in veterinary medicine. 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.

Device manufacturers who exclusively manufacture, or distribute veterinary devices are not required to register their establishments and list veterinary devices. Firms that manufacture radiation-emitting devices do need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH).

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 labeling and regulations. This includes devices marketed in another country and offered for importation into the U.S. A review may be requested by forwarding complete labeling, including any instruction manuals, promotional literature, and diagrams or photographs, to the following address (do not send actual devices):

Food and Drug Administration
Center for Veterinary Medicine
Division of Compliance (HFV-230)
7500 Standish Place
Rockville, MD 20855

Although the Quality Systems Regulations published in Title 21, Code of Federal Regulations (CFR), Part 820, apply to human devices only, FDA recommends that veterinary device manufacturers become familiar with these regulations and be guided by them in manufacturing/assembling their device articles. Title 21 CFR, Part 800 to 1299 deals with the regulations governing medical devices. Copies may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Mail Stop: SSOP, Washington, DC 20402-9328. See http://www.gpoaccess.gov.

Adulterated or Misbranded Devices

Animal devices which are not safe, effective, and properly labeled are deemed to be adulterated and/or misbranded under the Act. Examples of when something may be considered adulterated or misbranded:

  • If it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health (adulteration). §501(a)(2)(A)
  • If its labeling is false or misleading in any particular (misbranding). §502(a)
  • If its labeling fails to bear adequate directions for use (misbranding). §502(f)(1)
  • Adequate directions for use means directions by which the layman can safely use the device. Those devices which, because of the nature of the device itself or because they are for use in a condition which requires the training and expertise of a veterinarian and thus for which adequate directions for lay use cannot be written, are prescription devices. These devices must be labeled with the veterinary prescription legend “Caution: Federal law restricts this device to sale by or on the order of a licensed veterinarian,” and they must be used under the supervision of a licensed veterinarian.
  • If it is dangerous to health when used in accordance with its label directions (misbranding). §502(j)

Devices not in compliance with the Act may be subject to seizure, and firms and individuals responsible for marketing these illegal devices may be subject to other penalties of the Act, such as fines and even imprisonment.

Dental Devices

Any product that bears a claim to affect the dental health of an animal through a mechanical rather than a chemical action on the teeth and/or gums is a dental device. Such a product might be a nylon or rubber bone. Because of the abrasive action of these products on the teeth, they do help to clean the teeth of dogs. Therefore, at this time FDA would not object to these products being labeled with claims for helping to clean the teeth of dogs and marketed, provided there is no safety problem for the animal.
Dental devices that are labeled with claims for the prevention and/or treatment of dental disease such as gingivitis and periodontal disease would be considered of higher regulatory priority. These products may be subject to regulatory action under the Act if marketed.
The following veterinary medical devices have received regulatory attention in the past:

  1. Electronic dog collars which would emit an electrical shock when the dog barked. These collars were found to be dangerous because they caused burns to the animal and could be activated by other noises, including other dogs barking.
  2. “Cold Laser” devices were found to be misbranded because they could not achieve the therapeutic effects they claimed.
  3. Pulsed magnetic wave therapy devices were found to be misbranded because they were making excessive therapeutic claims for many more conditions than scientific studies could support.
    In addition, electronic veterinary devices, which emit radiation, are subject to the Radiation Control for Health and Safety Act, which has various performance and safety standards.

In addition, electronic veterinary devices, which emit radiation, are subject to the Radiation Control for Health and Safety Act, which has various performance and safety standards.

  1. The Federal Food, Drug, and Cosmetic Act (the Act) defines medical devices 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.” 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.” Examples of devices include such things as needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, certain diagnostic test kits, and dental appliances.