FDA's Regulation of Mobile Medical Apps Will Probably Confuse You
FDA's Bakul Patel took the stage at the WLSA Wireless Convergence Summit 2013 using an iRobot RP-VITA to speak with the audience on the status of FDA's mobile health application regulations. It was a gesture as symbolic as it was quasi-futuristic. Patel could have just as easily conferenced in using Skype or Facetime (but then again this is a health conference). Likewise, given the current stage of FDA's draft guidance on mobile medical apps, one has to wonder if there might be a more convenient way...or at least one that brings up fewer questions.
Patel reasserted FDA's commitment to innovation and also quelled fears that the agency might overreach in its efforts to regulate mHealth. The big takeaway is that unless the app was created specifically with a medical purpose in mind, FDA has no desire to regulate it. For example, “Electronic textbooks or smartphones themselves are not medical devices,” Patel says. “A generic smartphone with no medical purpose is not a medical device, and FDA has no intention to regulate it.”
See the compete article @ http://www.mddionline.com/blog/devicetalk/fdas-regulation-mobile-medical...
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