Hi All,
recently the FDA approved the First Digital Pill in US, Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken, The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

Question: Its a combination product, apply PMOA (primary mode of action), and find is it a drug or device? what you need to submit to FDA to approve this product?
Hint:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm
https://www.npr.org/sections/thetwo-way/2017/11/14/564112345/fda-approves-first-digital-pill-that-can-track-if-youve-taken-it