September 23, 2013 • by pzettler Reblog from
The Stanford Center for Law and Biosciences:
“FDA will focus on regulating the subset of apps that pose the greatest risks to patients: (1) apps that are used as accessories to already-regulated medical devices, e.g., an app that alters the function or settings of an infusion pump, and; (2) apps that transform a mobile platform into an already-regulated medical device, e.g., an app that uses an attachment to a smartphone to measure blood glucose levels.”
I’m not certain about neurotech and the FDA Medical Device Exemptions:
or if this would be enforced?