[kohanz]

I don't know if this makes you feel any better, but if the device manufacturer are indeed playing by FDA rules, the e-mails that you have sent should have triggered serious investigations into these bugs. That doesn't mean that they would be fixed, but they would be triaged to assess how and when they happen, and what risk they pose to patients.

This is known as the Corrective Action, Preventative Action (CAPA) process [0]. Note that the investigation into your complaint is an absolute requirement. Not just e-mails, but even phone conversations, or comments made in passing verbally - if any of them constitute a comment (positive or negative) on the device, this needs to be logged and, if the comment warrants it, an investigation must take place.

So either your comments have been or are in the process of being investigated, or the device manufacturer is not following the FDA rules.

[0] http://en.wikipedia.org/wiki/Corrective_and_preventive_actio...