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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - January/February 2004

FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 1

The CVM Home Page receives quite a bit of mail. The questions and answers featured here are composites of multiple questions the Home Page has received on the same topic. If you would like to send a question to the CVM Home Page, please visit www.fda.gov/cvm and select “contact CVM,” or write us directly at CVMHomeP@cvm.fda.gov .

We have developed a device for use in horses for use with homeopathic medication and pharmaceuticals. The device will be sold without any medication. Does FDA have to approve the product before it can be sold in the U.S.?

No prior approval is required for devices. According to information on FDA's website, “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 and Radiological Health. (See www.fda.gov/cdrh/devadvice/311.html )

“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, mislabeled, 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 devices should meet or be equivalent to the performance standards. This is especially important for devices that can be used both in humans and animals, such as examination gloves, sterile catheters, infusion pumps, etc.”

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

I am developing a line of pet grooming products (shampoos and conditioners) and am trying to find out if there are any FDA labeling requirements or laws that apply to such products.

The animal counterpart of a cosmetic is commonly referred to as a “grooming aid.” The Act defines cosmetics as pertaining only to human use (201(i)). Therefore, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control. However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are considered drugs and would be subject to regulation as new animal drugs under the Federal Food, Drug & Cosmetic Act.

What should I do if I find a pet food product that is defective?

You should contact the complaint coordinator at the FDA District Office in your area. You can find information about this program and a listing of the complaint coordinators at www.fda.gov/opacom/backgrounders/complain.html . We also suggest that you contact the pet food company so it is aware of the complaint.