The U.S. 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 in the U.S.A. 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.
Classification of Devices by the European Commission
While device classifications for products which are put into the market in the U.S.A. are ultimately determined by FDA pronouncements on a case by case basis, the European Commission provides a complete set of formulas and guidelines for use in classifying devices. It is best to consult such information directly since it cannot be quickly summarized within this website page.
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