Medical device cyber security is currently big issue in the medical device industry. Here is a short news story on the topic with some interesting links: http://www.qmed.com/news/fbi-warns-medical-device-hacking-risk.

The last paragraph struck me as particularly interesting. In the same way the post office sometimes gets blamed for lost checks that were never mailed, I think the FDA sometimes gets blamed for complicating things that medical devices companies don’t know how to or simply don’t want to do. I went to the FDA website and found the following Guidance Document: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm077812.htm (those of you how have heard my FDA presentations know how useful guidance documents can be).