” Breaking News – FDA Issues Final Guidance on Mobile Medical Applications”

September 23, 2013 • by pzettler Reblog from
The Stanford Center for Law and Biosciences:
http://blogs.law.stanford.edu/lawandbiosciences/2013/09/23/breaking-news-fda-issues-final-guidance-on-mobile-medical-applications-2/

“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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm

or if this would be enforced?

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