Article Excerpt: 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 One new section in the final guidelines — that was not included in the draft guidance — is a list of the types of apps that the FDA says will fall under its enforcement discretion.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 for these mobile apps because they pose lower risk to the public.” So these apps won’t be regulated as medical devices. It’s an important section of the document since it adds to the clarity of mobile medical app regulation.
Full Article: http://tinyurl.com/mgxgrw7
Article Source: MobiHealthNews