FDA Has No Plans for Widespread Regulation of Mobile Apps: Official

An FDA official unequivocally told a Thursday session of the House Oversight and Investigations Subcommittee that the agency will not regulate the general sale of smartphones and tablets, defusing industry scare tactics around the oversight of medical apps. The FDA “would not consider entities that exclusively distribute mobile medical apps, such as the ‘iTunes App store’ or the ‘Android market,’ to be medical device manufacturers,” Christy Foreman, director of CDRH’s Office of Device Evaluation, told the subcommittee.
Devices & Diagnostics Letter