I think every company is different when it come to categorized ther product but, most of them they will have a focused vertical or sector. each vertical will have it's series with different version. so for each sector there is a product series with in the product line that best fit the applicaition.

According to the FDA, the medical devices are characterized into three categories based on a few factors. According to them, "The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk."
This was taken directly from the FDA website.

Medical devices classifications are broken down into class I, class II, and class III devices. How a device is classified depends on how much of a risk the device presents to the user and how novel the device is. It is up to the FDA to determine which class to classify a given device. Class I devices are the lowest risk devices and are therefore the ones with the least strict regulations. Class II devices are more high risk, but many times they are substantially equivalent to a predicate device and then it is up to the company to demonstrate substantial equivalence on a 510(k). The third class is the Class III device which is the most high risk and often either supports or sustains human life or is a completely novel device for which there is nothing substantially equivalent to compare the product to. Class III devices therefore are the ones out strictly regulated by the FDA.

I think we can all agree that the classification comes from the risk and novelty of the device. However when preparing my response for another forum post, I learned that this classification system was made back in 1976. And according to the link - https://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm - there have been very little updates to the classification system, even some recalls on a class 1 device.
I thin a better question to ask would be "should the classification system be changed/updated/modified to include more modern problems?"
Going off of my new question, I would say yes. I think they need to stricter regulation on their products to include modern day technology and advancements.

That is an interesting topic. Medical Devices are categorized based on the risk associated with the usage of the device. The categorization is based on different parameters such as
1. The general regulatory controls:
General controls are the fundamental provisions that ensure the safety and effectiveness of regulatory devices. This regulatory control includes provision for adulteration, misbranding, device registration, repair or refund etc.
2. The special regulatory controls:
These are the additional controls to the general regulatory controls for reasonable safety and usability assurance that includes specific labeling such as usage methods, guidelines, recommendation etc.
3. The need of Pre Market Approval (PMA):
PMA is a process brought in practice by FDA (Food and Drug Administration) to review a medical device for safety and effectiveness evaluation. For class III medical devices, there a high level of risk associated.

@f-dot, I agree that the FDA does have to stay on top of modern day devices applications, but don't think modern day technologies need a different classification system. I think it is still useful to a classification system based on risk, Class I, Class II, and Class III devices. I think they could maybe include more guidance documents regarding more modern devices, but I think it makes sense for them to still be classified into a Class I, II, or III device. Were you thinking they would add a Class IV device or how would you envision a new modern classification system? Would adding more classes make it more complicated, would it be based on risk or something else?

Completely re-making the classification system seems very unnecessary to me. Granted I have no experience of using this for anything outside of this class, but I think that there are fairly specific qualifications for each class, for example any device that sustains life, produces life or death information, or has a largely unknown risk profile will fall under class 3, requiring extensive clinical and safety data. As far as shifting the standard for each class, and adding a class 4, class 5, or any amount of extra classes of risk, I think would only complicate the process of deciding on classification of a device. I think the three classification groups could have some updated qualifications to account for modern day devices. But the system for assessing risk has gotten the job done for many years, and seems that it will continue this way for years to come, so to answer the question, no I do not think there should be more classes added to a new classification system.

Regulatory Standards for medical devices has a 3 class classification system that are class 1,2 and 3. They are classified on the basis of risk that is present while using them on a patient. As the class increases the risk of the device increases.

Class 1 medical devices have lowest to moderate risk. 47% of medical devices fall underclass 1 and 95% of these are exempted from the regulatory process. Manual stethoscope, bandages are examples of class 1 medical devices.

Class 2 medical device have moderate to high risk. 43% of medical devices fall under this class. Wheelchair, pregnancy test kit are some examples of class 2 devices.

Class 3 medical devices have highest risk of all medical devices. 10% of medical devices fall under this class. Implantable pacemaker is an example of class 3 medical devices

A straightforward way to classify a medical device is to go on the FDA website under their device classification panels page. This web-page allows one to locate their classification regulations by selecting which field their device falls under (i.e. cardiology, dental, immunology, neurology, etc) and correlating it with its associated citation (21CFR). Once the field is determined, all that is left is to select the device that closely matches whatever product is under development. For example, if the field of cardiology is selected, then a page will open up that lists all associated devices, such as blood pressure cuffs, a variety of catheters, specialized syringes, etc. Once the exact device has been selected, the site will then list the CFR Title 21 page that states the device's identification followed by its classification (Class I, II, or III). This is the categorization method that is implemented in the U.S. whereas other countries follow different sets of classification.

If a device is novel and new to the market upon its expected release, then the FDA would commence its categorization based on the risk that the device carries based on its device's function. The PMBOK guidebook states that during the development phase, risk can be categorized by analyzing the availability of resources throughout a project (defined by the RBS: resource breakdown structure) as well as analyzing the areas of a project that would be most affected should any hazards occur (defined by the WBS: work breakdown structure). Are there any other techniques that can be used by either the FDA or a project team that can pinpoint root causes of risk/hazards? What exactly is root-cause analysis (RCA) and how can it be implemented when it comes to classifying a medical device? What classification methods do other countries enforce towards categorizing medical devices?

(1) "A Guide to the Project Management Body of Knowledge (PMBOK Guide)" (2013) Project Management Institute, pp 332-333

(2) FDA website under CFR Title 21

The classification system for medical devices, according to the FDA, is based on risk of failure when used or implemented. Class 1 being the least invasive or safest(such as tongue depressors), class 2 having moderate risk(or having a similar FDA approved product on the market already), and class 3 having the highest risk with a novel approach.

The medical device is generally categorized in three class:- class 1( Low moderate risk medical devices), class 2(low to moderate risk medical devices), class 3(moderate to high risk device). The categorization is been made by FDA. Every Single medical device comes in the market should follow this protocols.

The FDA's CDRH (Center for Devices and Radiological Health) follows a set of protocols to classify medical devices as class 1, class 2 or class 3 device depending on the risks involved with the device. Class 1 device are devices that do not have any associated risks with it and hence and are exempt from premarket notification 510(k) while class 2 devices do need a premarket notification 510(k) due to the moderate risks associated and finally the class 3 devices need a premarket approval (PMA) because of the high risks related to these devices. The class 3 devices need to submit claims of clinical trials in support of the device.

For every medical device, whether it involves risk or not, it needs to be regulated by FDA. And the center that regulates the medical devices is CDRH which is the Center for Devices and Radiological Health. They review and approves medical devices. Each device is classified into class I, class II, and class III. Class I are the most general devices and they are exempt from pre-market notification. Class II requires some risk and controls. It requires 510(k) documents FDA regulations. lastly, Class III requires serious control and also premarket approval application in order to market the device.

Medical devices are regulated by the us food and drug administration (FDA), there is a specialized division names Center for Devices and Radiological Health (CDRH) which reviews device application and monitors the safety of the medical device sold. The devices are classified on the basis of the risks possess to patients and the users. There are three classes in medical devices in which the medical devices are classified they are: Class I, Class II and Class III with level of risk low -medium, medium- high and high respectively. FDA classifies medical devices based on the risks associated with the device.