Article | July 20, 2018

FDA's Holiday Gift: Digital Health Policy Upgrades

Source: DIA

Ann Meeker-O’Connell, DIA Global Forum, US Regional Editor

FDA’s Holiday Gift: Digital Health Policy Upgrades

On December 7 and 8, holidays came early for digital health product developers in the form of three new guidance documents from the US FDA.

These include: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (draft guidance); Clinical and Patient Decision Support Software (draft guidance); and Software as a Medical Device: Clinical Evaluation (final guidance). According to FDA Commissioner Dr. Scott Gottlieb, this trio represents “new, significant policy developments” and is intended to “advance the FDA’s approach to the development and proper oversight of innovative digital health tools.”