LIGHT TOUCH BY FDA. “97,000 mobile health applications are available at major app stores. The vast majority won’t have to be cleared through the FDA, which on Sept. 23 completed regulations on the level of oversight such products will receive. Apps that turn a smartphone or other gadget into a regulated medical device, such as an electrocardiogram machine, must be submitted to the agency for review. Companies that don’t comply risk having their product banned in the U.S.” (Sept 23 2013). ”
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http://mobile.businessweek.com/articles/2013-09-26/fda-regulators-eye-medical-apps-for-mobile-devices