Comments to FDA’s Draft Guidance on Mobile Medical Applications:

This letter details the Coalition’s comments. In short, the Coalition believes that the FDA has taken a significant step toward the appropriate regulation of mobile health(“mHealth”)3 technologies, but there is more work to be done. While others may suggest that FDA regulation of mobile medical apps and other mHealth products is not appropriate at this time—with some requesting that FDA withdraw its guidance document for further consideration of the impact of regulation on the industry—we believe that clear, predictable, and narrowly-tailored regulation is necessary to ensure patient safety and to promote innovation.