'In this whitepaper, the Coalition analyzes two fundamental questions: (1) what mHealth hardware and software will the U.S. Food & Drug Administration (subsequently referred to as the FDA or the Agency) regulate and (2) if such products are regulated, in what device classification will the FDA place them? The three device classifications determine, among other things, whether a given product requires some sort of premarket clearance or approval from the FDA. The Coalition tackles these questions because, quite simply, the answers are fundamental to the business planning process and companies as well as investors need answers as soon as possible to maintain innovation.'

Source: Thompson, B. M., et al., 2010. mHealth Regulatory Coalition.