UDI Medical Device Classifications
What is a Medical Device?
Medical devices fall into one of the following three descriptions.
- It is an instrument, apparatus, implant, in vitro reagent, or similar or related article.
- It is used to diagnose, prevent, or treat disease or other conditions.
- It does not achieve its purposes through chemical action within or on the body (which would make it a drug).
Class III Devices
- Support or sustain human life.
- Are of substantial importance in preventing impairment of human health.
- Present a potential, unreasonable risk of illness or injury.
- Examples: implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, etc.
Class II Devices
- General controls alone cannot assure safety and effectiveness
- Existing methods are available that provide such assurances
- Examples: powered wheelchairs, infusion pumps, surgical drapes and an implantable radiofrequency transponder system for patient identification and health information
Class I Devices
- Not intended to help support or sustain life
- Not intended to be substantially important in preventing impairment to human health
- May not present an unreasonable risk of illness or injury
- Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments
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