Yeah, a bandaid would be like class 1. A needle or something like that would be class 2. Class 3 would be like a pace maker. There are very clear legislation that provides tremendous amounts of guidance in solving these situations by making it crystal clear what is what. This makes it easier for the engineers. 

While the classification of medical devices does depend on the level of risk the device poses to patients, its designated classification really depends on the mechanism of action. For example, if the medical device is a simple wound dressing (like a bandaid), it falls under Class I because it's not stimulating a biological phenomena. However, if you add glycosaminoglycans (GAGs) to the bandaid to stimulate cell migration into the wound by solely functioning as a scaffold, this would now probably fall under Class II. If your bandaid has growth factors that are stimulating cell growth, this now falls under Class III because it's mechanism of action is through direct stimulation of a cellular receptor.   

It is always important to know the distinction between the three classes, as stated multiple times in the lecture and the mini simulation because it can lead to many avoidable expenses and loss of time. In the medical device industry, I believe that the more invasive a product is, the more chances there are for it to be class III and require clinical/animal trials. Anything that will be placed "inside" the body or biologically interact with the body is pretty much a class II or class III device, class I devices are mostly external devices that do not interact with the body's biological functions.

I am currently working on a project that includes a wound closure device which uses medical adhesives to "glue" a wound shut. On a high level, there is an external device that has a glass ampoule containing the medical adhesive that a surgeon would place on a cut and wait for to dry until the wound has closed. I am interested in hearing what class people think this device would be? 

@ms2768 This is an interesting topic, especially because I always get confused between Class II and Class III medical devices. Devices in Class II are considered to have a moderate risk level, whereas devices in Class III are considered to have a higher risk level, and they typically require a more rigorous pre-market approval (PMA) process. In the case of a wound closure device that uses medical adhesives, the classification would depend on factors such as the intended use, indications for use, and the level of risk associated with the device. However, based on your description, it is possible that this device could fall into either Class II or Class III.

Well, it's an interesting question. I think in addition to the risk factor some other things are also related.

such as class II, which usually requires animal testing and occasionally requires human testing. However, class III always requires human testing. 

In addition, medical devices should be classified correctly. Otherwise, it will significantly impact the project timeline.  

There is a lot of legal regulations that make it easier to assign a class to a device. You would be surprised. In my opinion, there is a lot of guidance on even specific devices for specific organs or types of procedures. I think all of this will help one assign a classification to a product. 

Medical devices are categorized by the FDA into three main classes, Class I, II, and III. This classification provides an essential framework for assessing the hazards involved and defining regulatory criteria. When designing and developing medical equipment, biomedical engineers must adhere to this classification system. Class I devices, which are considered low-risk, are governed by general restrictions, such as following good manufacturing procedures and labeling regulations. Class II devices require additional special controls, like performance standards and post-market surveillance, due to their moderate level of risk. A few pieces of diagnostic equipment are examples of Class II devices. On the other hand, Class III devices—which are deemed to be high-risk—face the strictest regulatory scrutiny and frequently need pre-market approval (PMA). These devices, which include implants and equipment used to sustain life, require extensive proof of their efficacy and safety. In order to comply with regulatory standards and ensure the market is supplied with safe and effective healthcare solutions, biomedical engineers must carefully evaluate the features and intended usage of their devices to determine the right classification. It is imperative to stay informed about modifications to regulations and standards in order to ensure compliance throughout the lifecycle of a product.

It is very important to understand the differences between the three classes early on in a project because it can help save money and time. Typically, Class I devices are low-risk devices, which are known devices with a long history of safe use. Class I devices do not require pre-clinical or clinical trials. Class II devices are moderate risk devices that are similar to other medical devices in the past. 510(k) is typically required by the FDA for this class of devices. Also, pre-clinical trials are conducted to check the safety of the device. Class III devices are high-risk devices that are complex and critical to maintaining or saving human life. PMA is required by the FDA for Class III devices. In addition, pre-clinical and clinical trials are conducted to check the safety of Class III devices.