I have not had an experience working with PMOA for a combination device yet. Upon some researching, I have found out that PMOA is very critical when establishing a product’s regulatory and product development framework. Technically speaking when we need to identify the function of a product, we look at what the product does and where is the greatest impact. In other words, if we have to determine the primary mode of action of a combination device, then we need to determine what the most important therapeutic action. Basically, what action of the device makes the greatest contribution in overall effect of the device.

In a device, list out all the components and their intended use in comparison with the overall intended use of the device. Then, identify one component without which the device would not reach its intended use.