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

More than two years after issuing its draft guidance on the regulation of mobile health apps, the U.S. Food and Drug Administration has finally released its final guidelines.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

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