What would be considered a medical device?


What would be considered a medical device? A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.


How do you classify a medical device?

FDA Authorization of Medical Devices
  1. Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
  2. Class II devices are intermediate-risk devices. ...
  3. Class III devices are high-risk devices that are very important to health or sustaining life.


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