Regulation of Devices
There are 3 classes of medical devices. A Class I medical device is typically designed to perform simple operations and have almost zero or no risk involved in their application. These devices are required to meet regular FDA guidelines: that is, they must be registered, branded and labeled accordingly, made properly and the FDA has to be told of the devices' existence before it is sent to market. Three examples of this type of device are: elastic bandages, tongue depressors, and examination gloves.
A Class II medical device is a little more complex than a Class I device, and its application does include some risk -- but the risk is low. Like Class I, these devices also have to conform to regular FDA policy, including labeling guidelines; but they must also be monitored in order to make sure they meet specific standards when being utilized. This includes conducting after-market check-ups. Class II devices are the majority of medical devices in the field: three examples include x-ray machines, self-powered wheelchairs, and infusion pumps.
A Class III medical device is of the most complex design of the three classes of devices. These devices come with very strict protocol...
Like I and II devices, these must follow FDA policy and be approved prior to going to market. But they also must pass a scientific review. These devises are used to support life and so if they are used improperly or are not designed adequately, life can be lost. Three examples are: pacemakers, implanted cerebral simulators and heart valves (Litron, 2015).
Premarket notification [501(k)] is required for all three classes of devices. PMA is required for Class II and Class III devices. However, an Investigational Device Exemption (IDE) can be given if the device is being used in a clinical study so that information about its usage and effects can be obtained in order to make a proper judgment regarding PMA or Premarket notification [501(k)] (FDA Device Advice, 2015).
When it is said that regulation of medical devices is 10 years behind the regulation of drugs, this means that regulatory practices are not as advanced for devices as they are for pharmaceuticals. This may be true in one sense, but in another it is not -- and the comparison is essentially an unfair one, as the two are entirely different in terms…
