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luloo117117
Veterinary device is medical device or not? According to the following FDA's definition, veterinary device is medical device, but why people always call device used not for human is not medical device? Confused.
Based on FDA's memo:
http://www.fda.gov/cvm/regofdevices.htm
Based on FDA's memo:
http://www.fda.gov/cvm/regofdevices.htm
May 2003
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.
---FDA
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.
---FDA