Anthony,

The premise of the device is interesting and can provide needed support with suggested treatment. The reason for the disclaimer, in my opinion, is because electronics can fail. If they state that this can happen 100 % of the time, they are opening themselves up to hard backlash. If the sensor is damaged, or if the patch isn't placed correctly the intended result can be impacted. There are a lot of factors that come into place that the company needs to protect itself from.

I agree with your concerns regarding the potential risks associated with this combination product. The fact that it is both a device and a drug and collects sensitive personal information makes it a potential target for hacking, which could lead to serious legal and ethical issues. The importance of addressing these issues and ensuring the security of personal information cannot be overstated. It's crucial that appropriate measures are taken to mitigate these risks and prevent any potential breaches.

Since the digital pill is considered a combination product the functions must be taken into account to see what will need to be sent to the FDA. As stated in previous responses, the primary mode of action for the device is to track when the pill is dispensed. This will count as a medical device instead of a drug because it is not connected to any drug in particular. This would be submitted to the FDA throw the CDRH who review and approve medical devices. Along with that, since the device is electronic based it will fall under Class 3 and need premarket approval. This includes items like a 510(k), and IDE and PMA. Since it is an electronic device it needs to include more items that are sent to the FDA for approval.