Finally, FDA tells mobile health app developers what it plans to regulate

If you are a mobile developer in the health care space and you are not paying attention to your regulators, you really need to be. Storming the castle is fun and all, but do it smartly or you will get burned down the line.


More than two years after issuing its draft guidance on the regulation of mobile health apps, the U.S. Food and Drug Administration has finally released its final guidelines.

By some counts, there are about 40,000 health-related mobile apps available for download on the iPhone, Android devices or other smartphones. The vast majority of these apps exist outside the scope of F.D.A regulation, but mobile health app developers have still been waiting for the agency’s final word on where it plans to focus.

On Monday, the F.D.A. said its oversight will apply to two broad categories of apps:

  • Those intended to be used as “an accessory to a regulated medical device” – for example, an app that enables a healthcare provider to diagnose a condition by viewing a medical image from a picture archiving or communication system on a smartphone or tablet; or
  • Apps that “transform a mobile platform into…

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