I strongly agree with RyanRattazzi's point about adding more tiers to the medical device classification system: it would be an unhelpful and unneccesesary addition to add something like a class IV device. From a risk indication perspective, Class III devices already indicate that the device presents the most risk for harm. To add a Class IV would not make sense: either you say it presents the "most, MOST" amount of risk (sounds a little silly right?) or you would make Class IV the most and reclassify the other three Classes to other degrees of risk. Reclassifying the classes like that would cause even more confusion around device classifcation than there already exists and would likely serve to create more harm than good. However, more description about the existing classes on what the criteria may help instead. In addition, a great addition to these classifications would be some kind of qualification standard for combination products, where MD manufacturers can have a pretty close idea of what jurisdiction of the FDA their combo product will land and what legwork they will need to do.
The classes defined by the FDA are Class I, II & III. Each company may label them however they want internally. Companies tend to give the projects pseudo/ temporary names while the product is still in development.
I agree with others that stated that FDA medical devices are classified by how severe the risk is to the public. The risk classification helps in including addition exams/protocals before release the product if it is class 2/3. Class 1 is the class that has the lowest risk while the other two classes requires additional regulation/special controls.
Medical devices had been categorized by FDA based on risks and the regulatory controls like class I, class II and class III. The devices are classified on how much the risk presents to the user. Class I device pose the lowest risk to the patient and class III pose the highest risk to the user. 10-15% of the devices falls under the class III. Every device that comes to the market should follow the protocols.
FDA classifies medical devices, There are three main classifications Class |, Class || , and Class |||. The assignment of a classification for a device depends upon the level of risk that is associated with the device.
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.
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.
Class III Devices: Class III devices are generally considered to be the most complex devices. They are considered to be the highest risk.
Medical devices are categorized in three classifications. The classes range from Class One to Three. These classifications are based off the harm that these medical devices present. The FDA classifies and groups these medical devices based on safeness and effectiveness.
Class 1 devices are low-risk devices and examples include a bandage, and nonelectric wheelchairs.
Class 2 devices are intermediate risk devices that and examples include a CT scan.
Class 3 devices are high-risk devices that are important for a healthy life, and examples include pacemakers.
