FDA Walks Fine Line With Medical App Regulation

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The proliferation of mobile devices (smartphones, tablets, etc.) has left the Food and Drug Administration in a bit of conundrum.  The agency must be strict in its oversight of the development of apps that could be construed as medical devices while at the same time not pose unwieldy restrictions on app developers.  To walk that fine line, the agency has released a guidance document that discusses their future approach to such technology.  The agency says they will place a focus only on those apps that can turn a mobile device into an FDA-regulated medical device or that can act as an accessory to a given medical device.  In coming to this conclusion, the FDA has provided some examples of what would constitute a medical device and what wouldn’t.  A blood pressure tracker assistant would perhaps not be regulated, although an app that helps measure blood pressure probably would.

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