This week, our class has focused on an important component of the regulatory overview: identifying the appropriate classification for medical devices. Class I, II, or III categorization is critical in determining the regulatory pathway governing the approval procedure. However, it has become evident that the criteria for establishing each class are not always clear. This ambiguity becomes more evident particularly when dealing with combination items across many regulatory categories. Addressing this complexity needs a detailed classification method that considers the particular regulatory requirements for each element of the combination product.
For example, in the mini-sim, one of the project options was the Tooth Regeneration Scaffold. Despite not being life-sustaining, it is a combination product, which makes it more difficult. The novel application of medicine on a scaffold raises many questions about safety and efficacy in a clinical environment. A concern is the processing of the medicine and scaffolds together, as well as their packaging for sale, which deviates from the typical method of drug sales.
The classification of medical devices can definitely be uncertain and especially unclear when it comes to combination products. It's another component that needs to be accounted/tested for, so I think it's always best to make it as simple as possible (also to limit any unintended interactions between components).
In reference to the tooth scaffold example presented in the MiniSim, I understand why it would fall under Class III, because the GSK3 antagonists are acting on the stem cells (as a drug) to stimulate enamel deposition. However, would this device be classified as a Class II medical device if it were solely made of biodegradable fluoroapatite microspheres? The tooth enamel is primarily made of hydroxyapatite, but one way to promote remineralization is by using fluorine because it forms a more compact complex than hydroxyapatite, as fluoroapatite, that can remineralize enamel. A similar approach is applied with mouth washes that incorporate fluorine.
If the device is only promoting natural remineralization with these microspheres, would this now be a Class II device? Or would the microspheres as a delivery vehicle require it fall under Class III?
I do believe there is some ambiguity in the classification of medical devices, especially when considering combination products. However, I'd make the argument that it is better to "overclassify" than "underclassify" the device. For the example of mouthwash with fluorine, I'd argue that it is more prudent to classify it as Class III from the onset. Class III devices require both animal and clinical testing, so if the device is reclassified as Class II no new testing protocols would need to be added. On the other hand, if it is initially classified as Class II, then the clinical protocol would need to be tested and performed, adding an unexpected obstacle to the project timeline.
Agreeing with the posts above, i believe there is ambiguity observed in the classification of medical devices. The classification of medical devices is based on control level that ensures the safety of the users and efficacy of the device. This allows the FDA to control and determine the regulation of the devices. Even though the FDA works consistently to work in adapting the advancing regulatory frameworks for advancements in technology, the advancement of technology and certain combination within products leads to uncertainty how to classify devices with advanced technology. I believe rather than increased updates to its regulatory framework, the FDA needs to further diversify their categorization to ensure appropriate classification of devices based on certain applications and safety levels for devices that fit into more than one category. Manufacturers are blinds towards the classification of medical devices leaving companies to unguided manufacturing and innovation of devices. The FDA and manufacturers may have differing opinion on the classification of devices based due to ever-changing regulatory requirements and risk assessment for particular parts associated within the product.
I both agree and disagree with the benefits of “overclassifying” a device as mentioned in a previous reply. On one hand, reclassifying a device from Class III to Class II is preferable to the opposite case in terms of not requiring additional testing. However, over-classification may lead to an unnecessary use of resources (budget, material, labor, and time) when attempting to fulfill Class III device requirements for a device that should have been classified as Class II. Clinical trials may cost a company millions of dollars. They also require extreme preparation and close observation. Instead, a change in either the company regulatory department’s classification process or the FDA’s classification system should be done to avoid underclassification or overclassification.
Has anyone had experience working in a company that had a product be reclassified? What steps were taken by the project team following reclassification?
