When Mobile Tech Becomes Medical Device
11/2/2016 7:29:51 AM
Health care, clinical trials, and technology are advancing at a record pace, and nowhere is it more evident than in the development and use of mobile health (mHealth) technologies. This is not lost on the media, with the amount of time and attention being put into the assessment and reporting on availability and accuracy of some devices. Fitness trackers like Fitbit are being constantly debated in regard to their merits and accuracy.
At the same time, regulators are trying to keep pace with the innovation and use of mHealth devices. The FDA has issued a number of guidance documents in the past two years clarifying its position on medical devices, software, mobile technology, and what the agency will pursue with regards to enforcement. Other international regulatory agencies are monitoring the release and use of medical devices and communicating their expectations as well.
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