One really critical point brought up during the video lectures/MiniSim was the importance figuring out what kind of device will be developed and its intended classification (Class I, II, or III) from the get-go. If there is a reclassification, this can require the medical device to undergo review through other FDA regulatory organizations, such as switching from CDRH to CDER or CBER, and prolong the approval process. This may also require the project team to acquire forms of data that they are not equipped to do, such as pre-clinical data. For example, if a company is capable of creating a Class I medical devices but through the incorporation of a drug into their implants, their novel device now falls under Class II and requires clinical testing. If the company has not established connections with hospitals/institutions that are capable of carrying out clinical testing, the entire project may not be feasible.
While this is a possible scenario, I would not expect this to occur very often (presumably). Most researchers are required to create crystal-clear project proposals that demonstrate feasibility; so if the planned proposal were to fail, I wouldn't expect the project team to pivot in a way where they would add very different components (e.g., drugs, biologics, etc.) that would require a reassessment of the device's classification just to ensure success of the device.
Can anyone think of a scenario where reclassification of a device would be likely?
While researchers strive for clarity in their study proposals, the complexities of medical device development may add unexpected elements. Consider this scenario: a research team is initially focused on creating a Class I medical device for non-invasive health monitoring. However, as the research advances, an unexpected possibility arises: the use of a novel drug delivery method to improve the device's performance.
The addition of a drug component increases the device's complexity, resulting in a transition from Class I to Class II classification. Despite the fact that the primary objective remains monitoring, this unanticipated development necessitates a revision of the device's categorization. Such situations highlight the adaptability necessary in the face of unforeseen possibilities, perhaps resulting in a reclassification to fit with regulations.
This is a very interesting topic because how possible it is in the "real world" for industries to experience something like this during projects. Based off the lectures and mini simulation this week, this is definitely a thought that popped up in my head as well. There has to be some scenarios where the classification and "primary mode of action" of the device is changed after the project activities have been initiated. I think along with the example of transitioning from Class I to class II due to an addition of a drug component, another example would be if a class II device changes to a class III device because they already have so many similarities. Class III devices definitely require clinical trials but class II devices can also require trials and the main differentiation is that class II devices are "newer" versions of existing devices. Thus, it does not seem too rare that a class II device would be reclassified to class III if there is something along the project timeline that causes it to be majorly different from a device that existed prior to 1976. As described in the mini-sim, it's extremely important that the device is classified as accurately as possible to refrain from additional costs and time, but I'm sure it happens in the industry setting where changes in design inputs throughout a project cause a shift in device classification as well. I would love to hear if anyone in the industry has specific examples from their experiences on this!
if the device is obvious then it is easy to classify the device. However, I think sometimes it is very difficult to classify a device when the device is complex. Sometimes it happens during the project. Then reclassification happens. It impacts the project timeline. If reclassification happens working procedure will also change. Most probably it may happen between class II and class III. In class II human trial is not required. however, in class III it is required. Therefore, if reclassification happens from class II to class III then human trials also have to be included.
Reclassification can happen if there are changes made after undergoing testing. For instance, imagine that a traditional hip implant is being tested. During this testing, the researchers note that the implant is loose at the bone-implant interface. Thus, to improve the device, they may add a biologic or drug to ensure that the implant more seamlessly integrates into native bone tissue. This is a practical example of how classification can switch from a Class II to a Class III or Combination product. So, as improvements are made during testing, reclassification may be necessary depending on the significance of the change being made.
Agreeing with @ms2768 being an interesting topic, i believe re-classification of a certain device would require multiple evaluations. As everyone is aware regarding the COVID-19 outbreak, vaccines that had shown success in completely killing the virus were instantly categorized and sold under Emergency Use Authorization (EUA). Now FDA has approved only few vaccines while others will not be further approved due to regulatory decisions. If there is a shift in the intended use of a medical device, it could potentially pose a change for the classification of the device. Another issue that could question a device's classification is when surveyed reports show adverse events that prompt reclassification.
Research projects need to be flexible since the creation of medical devices is a dynamic process that frequently involves unforeseen components. Imagine a situation in which a research team develops a non-invasive health monitoring equipment that is classified as Class I, but unintentionally adds a unique drug delivery system that raises the device to Class II status. This illustrates the necessity of adaptability to unanticipated events and how reclassification can be required. Device classification may change in real-world projects after they are launched. For example, a Class II device may become a Class III device because of modifications to its design or because it resembles an existing device. Reclassification may also occur after testing; one example is when a hip implant is modified to enhance integration. The consequences for project schedules and protocols, particularly in the context of Class II and Class III devices, highlight the significance of flexibility in the dynamic field of medical device development. Industry experts with firsthand experience with reclassification situations may be able to offer insightful opinions on real-world applications and lessons discovered.
