New FDA Head Lays Out Bold Plan for Digital Health Regulation

Published: Jun 16, 2017

The U.S. Food and Drug Administration Commissioner Scott Gottlieb offered a preview of a new Digital Health Innovation Plan in a blog post this week. It will clarify how the FDA regulates digital medical devices and apps. It is a significant development since it shows that the FDA will play a more active role than it has done as the private sector have pushed ahead with their own forms of vetting initiatives from Mount Sinai’s app prescription platform to Apple’s tightened health app criteria.

In the blog post, Gottlieb said the FDA will provide guidance to clarify its position on products that contain “multiple software functions”.

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