This medical device is both a device and drug, therefore it is considered a combination product as stated by regulation. The PMOA is too gather a signal of a patient who took their pill or not and monitors metabolic activity. However, there is a drug component that in turn creates biochemical pathway response. Therefore, a RFD (request for designation) had to be filled. With that ruling, CDRH took over as the regulator for this device and was filed as a Class 3 device in which an IDE was done, pivotal trials and PMA was done as well.

The imperative and critical concern is that this device can be an opening another ” can of worms” of some menace wanting to hack personal information which can lead to identity thief. Now you have legal and ethical issues that need to be fixed immediately.