I would argue that this product is a combination product. Abilify was first approved in 2002 and approved for use to treat Schizophrenia however the new novel aspect of this design is the sensor technology which tracks the ingestion of the pill. This product would elicit a chemical reaction in the body so it could not classify as just a medical device which is what I was tempted to say at first. The primary mode of action would be the sensor technology itself and the transmission of the data to the caregiver. There would need to be extensive testing performed on whether the sensor technology would interfere with the makeup of the drug once embedded into the pill.
Overall this would have to be submitted through a PMA approval process. Since the primary mode of action would be the sensor, it would have to monitored and reviewed by the CDRH. Additionally, since the sensor technology itself is rather novel, it would most likely go to panel where a board can review holistically the effects of the drug and device together rather than as separate entities. I would believe that device would be classified as a class III due to no prior predicates.