intended use

By  MHN Staff 07:03 am April 13, 2015
By Bradley Merrill Thompson With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor...
By  Brian Dolan 04:46 pm March 6, 2013
Source: mHealth Regulatory Coalition FDA Report Last week six members of the US House of Representatives Committee on Energy and Commerce wrote a letter to FDA Commissioner Margaret Hamburg MD to ask her when the agency expects to publish its final guidelines for how and when it regulates mobile medical apps as medical devices. The FDA draft guidance document on mobile medical apps was published...