Medical software regulation reforms (Sec. 3060)

Identifies five specific categories of medical software that, given certain conditions, will not be regulated by FDA as a device. Requires FDA to risk-classify device accessories separately from parent devices.

On June 15, FDA Commissioner Scott Gottlieb said guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies would be published in the "coming months." (Also see "US FDA's New Game Plan For Digital Health" - Medtech Insight, 16 June, 2017.)

FDA also included funds to implement surveillance of the excluded software categories in the Cures work plan. (Also see "FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More" - Medtech Insight, 9 May, 2017.)

21st Century Cures Implementation: Device Provision Updates

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