Understanding the Difference between Class I, Class II and Class III Medical Devices

The Federal Drug Administration (FDA) classifies medical devices. There are three main classifications Class I, Class II, and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device.

How Medical Devices are Classified

There are a number of factors that determine how a medical device is classified, these include:

  • The length of time for which the device will be used
  • If the device is surgically invasive or not
  • If the device is active or surgically implantable
  • If the device contains medicinal substances

Class I Devices

Class I devices are considered to be at the lowest level of risk of all medical devices and are therefore required to comply with the lowest level of regulatory control. Examples of Class I devices include: elastic bandages, dental floss and enemas.

Class II Devices

Class II devices are simple devices, though they are more complicated than Class I devices. They are also considered to be at slightly higher risk than Class I devices and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class II devices include: condoms, pregnancy testing kits and powered wheelchairs.

Class III Devices

Class III devices are generally considered to be the most complex devices. They are also considered to be at the highest risk and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class III devices include: implantable pacemakers and breast implants.

Finding the Classification of a Device

To find the classification of a device, and any possible exemptions, search the FDA Product Classification Database.

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