FDA MMA

FDA finalizes plans to deregulate MDDS health software

By Brian Dolan 06:03 am February 9, 2015

FDA's Bakul Patel Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status. Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where...

FDA makes clear it won't regulate apps like Apple's HealthKit

By Brian Dolan 09:49 am June 16, 2014

As MobiHealthNews noted last week in the introduction to our In-Depth report on Apple's Health app feature set, the FDA made a rare move on Wednesday by adding a new description for a type of mobile medical app that it would not regulate as a medical device. The FDA has actually added a total of four such new descriptions to its list in 2014. It just so happened that the latest app description to...