This is a still-evolving story but a great read and a valuable lesson to novice medical device marketers and entrepreneurs: ignore the FDA at your peril. As the author points out, FDA regulations are laws. People do go to jail and companies can be shut down for violating them.
The company developed a mobile app that “reads” urinalysis test strips. In what seems to be an ill-considered decision, the company apparently decided to ignore FDA regulations regarding classification of mobile apps and diagnostic software. It also did not react well to an initial warning letter advising that the app was a Class II device. I wonder what will happen next?