I agree with wms7 — the pill’s primary function is to cause changes in the body biologically and therefore, it would be assigned to the CDER. The sensor does not make actual changes to the body and therefore, is a secondary feature.

Although I think its a really interesting concept, I was actually really interested in two concepts that the article presented:

1. Does the pill present issues of privacy? If the data is transmitted from the sensor to the patch and then to a wireless device, this means that anyone with basic hacking skills might be able to gain access to this information. What issues would this present?
2. Trials using the medication did not indicate that patients were more likely to take their medication with the sensor anymore than they would their regular medication. In addition, it shouldn’t be used in case of emergencies because the sensor might not transmit — in that case, what is the use of this medication?