FDA Takes On Mobile Health Apps

The FDA Takes On Mobile Health Apps - IEEE Spectrum:

"But the public health agencies, big pharmaceutical companies, and start-ups that have pushed out apps in the past few years have outpaced U.S. government regulators. While it’s assumed that some medical apps are subject to regulations, the U.S. Food and Drug Administration (FDA) has not defined the scope of its oversight and has issued few enforcement actions. 


That’s about to change. The agency is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape they’ll encounter in the future, but they’re also nervous that overly broad rules will stifle innovation. 


While waiting for the final guidelines to be published, we surveyed notable industry figures on what they’d like to see in the rules. Here are their top-five requests to the FDA." . . .

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