A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth

RESOURCE TYPE
White Paper

FILE TYPE
Link

DATE ADDED
November 17, 2011

AUTHOR(S)
mHIMSS

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.