A combination product’s primary mode of action establishes its regulatory and product development framework as well as how it is viewed in the eyes of a regulator depending on which agency it’s assigned to within the FDA, as we learned from the mini-sim this week. Looking at this digital pill, I would argue the pills primary function is to act as a drug for its prescribed purpose, whether it’s for mental illness (as mentioned in the article) or something else. Since I believe its PMOA is drug related then it would be assigned to The Center for Drug Evaluation and Research (CDER) in the FDA. The aspect of it being able to track whether or not the pill was taken by the user is a secondary feature with the drug portion of the device being the most important in terms of helping the patient and overall purpose of this device in my opinion. With this information a company can prepare to deal with the assigned agency, CDER in this case, to hopefully one day get this product onto the market.