I do not have any experience with working with PMOA for a combination device. After doing research on this topic, I have come to the conclusion that if a company cannot identify a PMOA, a Request for Designation can be submitted to the FDA to determine the classification of a combination device. Additionally, before submitting the request, a meeting with the Office of Combination Products (OCP) can be set up if you are uncertain about the type of information to include or about the need to submit an RFD. A meeting with OCP would be helpful in providing the FDA with a better understanding of how the product works and guidance can be developed.