final guidance

By  Aditi Pai 06:14 am October 3, 2013
The FDA final guidance finally published last week and it included very few surprises. One new section in the final guidelines -- that was not included in the draft guidance -- is a list of the types of apps that the FDA says will fall under its enforcement discretion. That means that these apps may meet the definition of a medical device, but the "FDA intends to exercise enforcement discretion...