FDA Draft Guidance Could Spur Innovation in Diabetes, Cardio Spaces

A recent FDA draft guidance titled Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices proposes that the agency refrain from regulating certain low-risk storage and communication systems. Following the tri-agency FDASIA Health IT Report issued in April 2014, which proposes a risk-based framework for health information technology, FDA's proposed hands-off approach for these systems has signaled a general commitment to implementation of such a framework. In addition to the agency's involvement in the FDASIA report, FDA's change of course is driven by a number of other factors, including greater agency experience with these types of technologies, their low-risk nature, public feedback received as part of the FDASIA health IT risk-based framework, and the foundational role that these devices play in the larger health IT ecosystem.

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