The FDA medical device classification system (Class 1, 2 and 3) have been in place for many years and is based upon the level of risk a device poses to a patient. However, with the advance of technology, we are now seeing devices that may not fit into these classification categories due to the complexities of modern innovation. Software based tools for example may not fit well into the traditional categories outlined by the classification system, but can still significantly contribute to patient outcomes. This begs the question whether existing classification frameworks are sufficient enough to keep up with new innovations, or if it requires some level of reform.
Do you think the FDAs classification system is outdated, and if so, what changes need to be made to make it more effective for newer developing products? Conversely, do you believe that reform could introduce any unnecessary risks or uncertainty in the system? Let me know your thoughts on the topic.
When it comes to newer technology that does not only involve physical devices (such as software), reform would be necessary as the FDA would need to define how it assigns these solutions. This can include categorized class designation for certain products (be it where certain solutions like software fit) and HOW applicants are supposed to define it when filling out their Request for Designation.
Looking at software, there are actually terms that define kinds of medical device software: Software in a medical device (SiMD), which is what drives the device itself, and Software as a Medical Device (SaMD), which manages said device. This can provide a basis for designation in that regard.
For example, a solution that would allow patients to control cochlear implants would likely be defined by applicants as “a SaMD that would work to make patients’ management of their implants more accessible through their smartphone as opposed to necessitating audiologist visits.” Cochlear implants are defined as a Class III device (since it was first approved in 1984 as a novel technology and still poses patient risks) despite being revised & improved. Thus, software tied to a Class III product would likely mirror that risk. However, software alone might not do as much damage as the device itself, necessitating reform.
I think reform would be well placed in an increasingly interconnected world like ours, if done correctly. As such, the FDA needs to make sure it amends its classification scheme to fit various kinds of solutions and also takes into account the relationship between the devices/software, their functions, and how they affect the health of the patient to reduce any misunderstanding or indecision.
