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Thursday, January 21, 2021 6:29:40 PM
Animal Devices– The key difference between an animal device and an animal drug is how the product works. If it relies on a chemical action occurring in or on the animal’s body to work, the product is a drug, not a device. If it needs to be 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.
Unlike animal drugs, animal devices do not have to be approved by FDA before they can be marketed. Manufacturers and distributers of animal devices are responsible for making sure they are safe, effective, and properly labeled. FDA has the authority to take regulatory action if an animal device is adulterated or misbranded.
For the complete definition of the term “device,” please see the Federal Food, Drug, and Cosmetic Act at Section 201(h) [21 U.S.C. 321].
For more information about animal devices, please visit: How FDA Regulates Animal Devices
https://www.fda.gov/animal-veterinary/animal-health-literacy/what-fda-does-and-does-not-regulate#Devices
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