The key difference between an animal drug and an animal device is how the product works. If it relies on a chemical action occurring in or on the animal’s body to achieve its primary intended effects, the product is a drug, not a device. If it needs to be broken down (metabolized) by the animal’s body to work, the product is a drug, not a device.

Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices.

Recalls and Other Important Information:

The Center for Veterinary Medicine is sharing the following announcements from the FDA’s Center for Devices and Radiological Health about human medical device recalls that may potentially present significant risks to consumers or users of the product. CVM is sharing these recall announcements because these devices may be used in veterinary settings.

• Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose
• Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)
• Medical Device Shortages During the COVID-19 Public Health Emergency
• Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers
• FDA Statement on Quality Issues with Certain Cardinal Health Surgical Gowns and Packs 01-23-2020
• Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors 08/12/19
• Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy 08/05/19
• Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion 07/18/19

You can find information on any recall monitored by FDA by viewing Enforcement Reports.

For more information:

How FDA Regulates Animal Devices
Animal Drugs Marketed as Animal Devices
Reporting Problems with Animal Devices